A Randomized Phase II Trial of Induction Cemiplimab Plus Chemotherapy With or Without Fianlimab in Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer.

开始日期2027-02-07

申办/合作机构

The University of Chicago

NCT07511036

/ Not yet recruiting临床2期IIT

PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma

This is a phase II study testing the safety and preliminary efficacy of triplet ICB in treatment naïve patients with clinical stage III or oligometastatic stage IV melanoma with resectable disease.

开始日期2026-09-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT07281768

/ Recruiting临床2期IIT

Combining Capecitabine/Oxaliplatin Chemotherapy With Cemiplimab Alone or in Combination With Fianlimab or REGN7075 for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

The purpose of this study is to evaluate the safety and clinical activity of combining cemiplimab, cemiplimab/fianlimab, or cemiplimab/REGN7075 with capecitabine/oxaliplatin (CAPOX) for the neoadjuvant treatment of patients with microsatellite stable (MSS) locally advanced rectal cancer (T2 node-positive, T3 node-negative, T3 node-positive).

开始日期2026-07-01

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+1]

100 项与 Fianlimab 相关的临床结果

登录后查看更多信息

100 项与 Fianlimab 相关的转化医学

登录后查看更多信息

100 项与 Fianlimab 相关的专利（医药）

登录后查看更多信息

项与 Fianlimab 相关的文献（医药）

2026-05-01·CANCER

Fianlimab, a human lymphocyte activation gene‐3 monoclonal antibody, in combination with cemiplimab: Tumor‐specific expansion cohorts in advanced malignancies

Article

作者: Lakhani, Nehal ; Birnbaum, Ariel ; Malhotra, Jyoti ; Rischin, Danny ; Fang, Fang ; Cho, Byoung Chul ; Dy, Grace K. ; Pouliot, Jean‐Francois ; Kroog, Glenn ; Kaczmar, John M. ; Zhu, Xin‐Hua ; Papadopoulos, Kyriakos P. ; Sarker, Debashis ; Khaled, Ahmed ; Kim, Tae Min ; Mani, Jayakumar ; Chen, Shuquan ; Brennan, Laura ; Lowy, Israel ; Lewis, Karl D. ; Williamson, Stephen K. ; Dowlati, Afshin ; McDermott, Ray ; Fury, Matthew G. ; Hamid, Omid ; Salvati, Mark

Abstract:

Background:

The dose escalation phase of a first‐in‐human (FIH) study demonstrated acceptable safety and preliminary antitumor activity of fianlimab (anti‐lymphocyte activation gene‐3 [LAG‐3]) as monotherapy and in combination with cemiplimab (anti‐programmed cell death‐1 [PD‐1]). Here, the authors present safety and clinical activity data from the dose‐expansion portion of the FIH study in patients with advanced non–small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC), head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (CSCC).

Methods:

Anti–PD‐1/PD‐L1 naive (N) or experienced (E) patients with advanced NSCLC, ccRCC, HNSCC, and CSCC were enrolled in this phase 1 study (NCT03005782). Patients received fianlimab 1600 mg plus cemiplimab 350 mg intravenously every 3 weeks for up to 24 months. The primary end point was the objective response rate (ORR) per RECIST 1.1.

Results:

Investigator‐assessed ORR was 27% in NSCLC‐N (four partial responses [PRs]), 7% in NSCLC‐E (one PR), 20% in ccRCC‐N (three PRs), 7% in ccRCC‐E (one PR), 33% in HNSCC‐N (five PRs), 7% in HNSCC‐E (one PR), and 20% CSCC‐E (two complete responses; one PR). The most common treatment‐related treatment‐emergent adverse events among patients across all cohorts were fatigue (15%), rash (12%), pruritus (10%), infusion‐related reaction (10%), and adrenal insufficiency (10%).

Conclusions:

Fianlimab plus cemiplimab demonstrated modest clinical efficacy with an acceptable safety profile in patients with advanced malignancies across several tumor types mostly in treatment‐naive patients. Further investigation is warranted.

2024-12-16·CLINICAL CANCER RESEARCH

First-in-Human Dose-Escalation Study of Fianlimab, an Antilymphocyte Activation Gene-3 Antibody, with Cemiplimab in Patients with Advanced Malignancies

Article

作者: Kyriakos P. Papadopoulos ; Susanna Ulahannan ; Israel Lowy ; Haeseong Park ; Karen Kelly ; Glenn Kroog ; Shuquan Chen ; Sheila Masinde ; Tasha Sims ; Vladimir Jankovic ; Ana Gonzalez Ortiz ; Timothy A. Yap ; Filipa Lynce ; Anne Paccaly ; Jyoti Malhotra ; Ding Wang ; Nehal J. Lakhani ; Melissa Lynne Johnson ; Afshin Dowlati ; Giuseppe Gullo ; Robert G. Maki ; Jayakumar Mani ; Stephen Williamson

Abstract:

Purpose::

Preclinical data indicate that fianlimab (antilymphocyte activation gene-3) plus cemiplimab (anti–PD-1) enhances antitumor activity. Here, we report prespecified final analyses of the dose-escalation part of a first-in-human, phase 1 study (NCT03005782) of fianlimab as monotherapy and in combination with cemiplimab in patients with advanced malignancies.

Patients and Methods::

Adult patients received 1 to 40 mg/kg of fianlimab plus 350 mg of cemiplimab every 3 weeks (Q3W) across various dose-escalation schedules. Primary objectives were the rate of dose-limiting toxicities, adverse events (including immune mediated), deaths, laboratory abnormalities, and pharmacokinetics. Secondary outcomes were objective response rate, best overall response, duration of response, and antidrug antibody variables.

Results::

Seventy-eight patients were enrolled (fianlimab + cemiplimab, n = 47; fianlimab monotherapy, n = 31). One patient treated with 3 mg/kg fianlimab + cemiplimab experienced dose-limiting toxicities, including increased blood creatine phosphokinase and myasthenic syndrome. No maximum tolerated dose was reached. Any-grade treatment-emergent adverse events occurred in 90% of patients with fianlimab monotherapy, in 87% of patients with fianlimab + cemiplimab, and in 87% of patients who transitioned from monotherapy to combination therapy. Fianlimab pharmacokinetics were dose proportional and similar in monotherapy and combination therapy. Across patients who received fianlimab + cemiplimab, five achieved a partial response, three of whom experienced a response after transitioning from monotherapy to combination therapy. Fianlimab 1,600 mg Q3W (20 mg/kg in an 80-kg individual) is the selected dose for phase 2 and phase 3 studies.

Conclusions::

Fianlimab as monotherapy and in combination with cemiplimab demonstrated acceptable safety and preliminary antitumor activity, which is generally consistent with previous reports of cemiplimab.

2024-08-20·JOURNAL OF CLINICAL ONCOLOGY

Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma

Article

作者: Lewis, Karl D ; Paccaly, Anne ; Lowy, Israel ; Kim, Kevin B ; Salvati, Mark ; Brennan, Laura ; Mani, Jayakumar ; Fang, Fang ; Weise, Amy ; Yushak, Melinda ; Chen, Shuquan ; Rabinowits, Guilherme ; Mehmi, Inderjit ; Lakhani, Nehal J. ; Fiaschi, Nathalie ; Jankovic, Vladimir ; Spira, Alexander I ; Spira, Alexander I. ; Papadopoulos, Kyriakos P. ; Mehnert, Janice ; McKean, Meredith ; Gullo, Giuseppe ; Lewis, Karl D. ; Fury, Matthew G. ; Kroog, Glenn ; Papadopoulos, Kyriakos P ; Thomas, Sajeve S ; Fury, Matthew G ; Kim, Kevin B. ; Middleton, Mark R. ; Hamid, Omid ; Crown, John ; Middleton, Mark R ; Kaczmar, John ; Thomas, Sajeve S. ; Masinde, Sheila ; Wang, Fang ; Kim, Tae Min ; Lakhani, Nehal J ; Lee, Dae Ho

PURPOSE:

Coblockade of lymphocyte activation gene-3 (LAG-3) and PD-1 receptors could provide significant clinical benefit for patients with advanced melanoma. Fianlimab and cemiplimab are high-affinity, human, hinge-stabilized IgG4 monoclonal antibodies, targeting LAG-3 and PD-1, respectively. We report results from a first-in-human phase-I study of fianlimab and cemiplimab safety and efficacy in various malignancies including advanced melanoma.

METHODS:

Patients with advanced melanoma were eligible for enrollment into four cohorts: three for patients without and one for patients with previous anti–PD-1 therapy in the advanced disease setting. Patients were treated with fianlimab 1,600 mg and cemiplimab 350 mg intravenously once every 3 weeks for up to 51 weeks, with an optional additional 51 weeks if clinically indicated. The primary end point was objective response rate (ORR) per RECIST 1.1 criteria.

RESULTS:

ORRs were 63% for patients with anti–PD-1–naïve melanoma (cohort-6; n = 40; median follow-up 20.8 months), 63% for patients with systemic treatment–naïve melanoma (cohort-15; n = 40; 11.5 months), and 56% for patients with previous neo/adjuvant treatment melanoma (cohort-16; n = 18, 9.7 months). At a median follow-up of 12.6 months for the combined cohorts (6 + 15 + 16), the ORR was 61.2% and the median progression-free survival (mPFS) 13.3 months (95% CI, 7.5 to not estimated [NE]). In patients (n = 13) with previous anti–PD-1 adjuvant therapy, ORR was 61.5% and mPFS 12 months (95% CI, 1.4 to NE). ORR in patients with previous anti–PD-1 therapy for advanced disease (n = 15) was 13.3% and mPFS 1.5 months (95% CI, 1.3 to 7.7). Treatment-emergent and treatment-related adverse events ≥grade 3 (G3) were observed in 44% and 22% of patients, respectively. Except for increased incidence of adrenal insufficiency (12%-G1-4, 4%-G3-4), no new safety signals were recorded.

CONCLUSION:

The current results show a promising benefit-risk profile of fianlimab/cemiplimab combination for patients with advanced melanoma, including those with previous anti–PD-1 therapy in the adjuvant, but not advanced, setting.

103

项与 Fianlimab 相关的新闻（医药）

2026-07-15

·BioSpace

Q2 earnings arrive as pharma picks up steam, buoyed by dealmaking, policy tailwinds

iStock, panom73 Biopharma is entering its second-quarter earnings season riding high on a wave of massive deals and venture capital flow, plus a clearing of regulatory and policy overhangs. What can industry watchers expect to hear on the upcoming investor calls? Pharma is entering the second-quarter earnings season riding high on a surge of deals—and now largely unencumbered by previous policy headwinds. The XBI—a fund that tracks the performance of the biotech sector—is back to “pandemic peak levels,” Truist Securities told investors in a July 7 note, pointing to the metric as evidence not only of the industry’s recovery from the post-COVID crash but also of the momentum building as the calendar flips to the back half of the year. Truist expects to see revenue start picking up across the board, “a rebound from a traditionally softer start to the year.” Analysts will also be on the lookout for updates on the completion of major acquisitions and on upcoming data readouts. “We continue to sense easing concern toward regulatory and policy factors, previously top of mind, into the midterms,” Truist added. No doubt contributing to this ease is the exit of former FDA Commissioner Marty Makary, who stepped down from his post in May, closing out what Capital Alpha called “ the most damaging period in FDA history .” FDA After ‘most damaging period in FDA history,’ Makary will be hard to replace With Commissioner Marty Makary’s exit, the FDA will enter a period of “unprecedented” and “prolonged” leadership vacuum, analysts at Capital Alpha predicted, noting that the government will have trouble finding someone who will want to take the FDA’s reins. May 13, 2026 · 3 min read · Tristan Manalac Read more Alongside the clearing regulatory skies, biopharma in recent months has also ridden high on a swelling wave of deals. M&A, for instance, has hit a total cumulative value of around $80 billion, per Truist’s estimate. This sum includes the year’s four of largest takeovers so far, all inked in Q2: Sun Pharma’s $11.75 billion pickup of Organon, AbbVie’s $10.9 billion gambit for Apogee, GSK’s $10.6 billion purchase of Nuvalent Bio and Vertex’s $10 billion Crinetics play. There has also been an encouraging influx of money into the industry, with Truist documenting “healthy financing activity and robust appetite for new paper.” Indeed, Isomorphic Labs in May closed its eye-watering $2.1 billion series B round—the second-largest in the sector’s history. But even as headwinds ebb for biopharma overall, some companies, such as Amgen and Gilead, continue to face challenges brought about by certain market factors—and analysts expect to see some weakness in their prints here. Venture capital 5 largest VC rounds of H1 2026 Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace . July 8, 2026 · 9 min read · Tristan Manalac Read more What to watch for With the obesity market projected to hit up to $200 billion next year , this therapeutic space is top of mind for most analysts and investors—and here, Eli Lilly continues to be the most closely watched company. The pharma could deliver a “beat and raise quarter,” Truist wrote in a Lilly-focused note sent on July 8, pointing to “strong US script growth” in the company’s tirzepatide profile. Both the obesity brand Zepbound and the diabetes drug Mounjaro are poised to grow quarter-on-quarter, as per the firm’s projections. Q2 will also be the first full commercial quarter for Lilly’s weight-loss pill Foundayo, which won the FDA’s go-ahead on April 1. Figures for the oral drug don’t point to a blowout victory for Lilly, however, with Truist noting that Foundayo’s U.S. launch has been “off to a slower than expected start.” Here, Novo Nordisk seems to have eked out an edge, with its oral Wegovy reaching 1 million patients in May after just 16 weeks on the market, exceeding all expectations and marking what CEO Maziar Mike Doustdar called a “record-breaking start” in the U.S. Still, Truist remains optimistic about Foundayo, writing on July 8 that “we see substantial potential” for the pill, “particularly in the international market.” Editorial With oral obesity race underway, all eyes are on Lilly’s Foundayo launch Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug. April 10, 2026 · 3 min read · Jef Akst Read more Aside from Lilly, analysts are also keeping an eye on Pfizer, from which Guggenheim Partners expects to hear obesity updates, according to a July 10 note. The pharma has been aggressively building out its weight loss portfolio, winning a bidding war against Novo Nordisk last November to bag Metsera for close to $10 billion . A readout from berobenatide—the acquisition’s centerpiece, which is being trialed with an amylin analog—is expected later this year . Outside of obesity, Guggenheim also wants to hear about Pfizer’s “latest capital allocation and business development priorities,” given the impending departure of the pharma’s CFO Dave Denton on Aug. 16. Also on Guggenheim’s docket is AbbVie, which analysts expect to report $16.65 billion in revenue in Q2—largely in line with, if not slightly below, the $16.77 billion consensus forecast. Top-of-mind for the analysts, according to a separate note sent July 8, is the pharma’s progress toward closing its Apogee acquisition. Guggenheim is also looking forward to hearing from AbbVie how competitive dynamics have changed in the immunology space since the entry of Johnson & Johnson’s plaque psoriasis pill Icotyde after its March approval . Aesthetics is also an area to watch, the group continued, especially following the FDA’s April rejection of trenibotulinumtoxinE, AbbVie’s successor to Botox. In cancer, Guggenheim is watching for updates from Merck on the market uptake for Keytruda Qlex, the subcutaneous formulation of the blockbuster PD-1 inhibitor, analysts wrote in a July 10 note focused on the pharma. Looking ahead, the firm awaits additional data for Merck’s Kelun Biotech–partnered antibody-drug conjugate sac-TMT. Antibody-drug conjugate (ADC) ASCO: Merck overshadowed by upstart biotechs but TROP2 plans begin to pay off Merck may not have had the splashiest presentation at the American Society of Clinical Oncology meeting, but the data show why the Big Pharma remains king of oncology, analysts say. June 2, 2026 · 4 min read · Annalee Armstrong Read more Merck is also set to provide updated sales figures for its respiratory drug Ohtuvayre and hypertension medicine Winrevair—both of which are also on Guggenheim’s radar. Moderna, meanwhile, is a rapidly emerging player in oncology with stock that has performed strongly in 2026 so far, surging 121% year-to-date. Much of this is “due to growing excitement toward mRNA-4157,” Jefferies analysts wrote in a July 12 note focused on the company. The personalized cancer vaccine is being developed along with Keytruda for melanoma. A late-stage readout is on track for later this year—and Jefferies is anticipating details on that during the company’s call. Otherwise, the firm expects Moderna’s earnings call to be “straightforward,” noting that the company has already projected a dip in income due to seasonality in demand for its COVID-19 products. Dark clouds still hang overhead While many key headwinds for pharma have petered out, some companies continue to face challenges. Amgen, for instance, has been contending with calls from the FDA to withdraw its rare disease drug Tavneos. While the pharma has come out in defense of Tavneos— requesting a hearing with the FDA and enlisting an independent analysis from the Duke Clinical Research Institute—Truist has nevertheless lowered its projections for the drug this year “in light of recent safety and data integrity concerns.” Tavneos made $119 million in the first quarter, a 32% year-on-year increase. Regulatory Amgen continues to defend Tavneos as global regulatory pressure mounts Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx. July 10, 2026 · 4 min read · Nick Paul Taylor Read more Another company dealing with difficulties is Regeneron, which in May revealed that its LAG-3 inhibitor fianlimab, when used with the PD-1 blocker Libtayo, failed to significantly outperform Keytruda in a Phase 3 melanoma study.BMO Capital Markets at the time took the failure hard: “Confidence shaken; frustration mounting around R&D execution.” Truist, in its July 7 note, suggested that investors have started moving on. “We note fading LAG-3 (fianlimab) frustration, with focus turning back to commercial execution.” On this front, the firm expects Regeneron to surpass the consensus earnings estimate, driven heavily by a strong projected performance of its Sanofi-partnered Dupixent. The firm also noted that investors could start clamoring for Regeneron to join the M&A frenzy sweeping across pharma, asking the company to “strike on more fulsome and de-risked portfolios,” though the analysts didn’t identify any potential acquisition targets. Cancer Regeneron misses again as melanoma combo bows to Merck’s Keytruda in Phase 3 The late-stage miss shakes analyst confidence in Regeneron’s clinical execution, according to BMO Capital Markets, also noting last year’s Phase 3 failure in chronic obstructive pulmonary disease. May 18, 2026 · 2 min read · Tristan Manalac Read more Truist also expects to see some slowness on Gilead’s end, with the firm forecasting that Q2 revenues could come slightly under the consensus estimate. Looking at drug script trends, the analysts anticipate sales of the daily HIV pill Biktarvy and the CAR T therapy Yescarta to also fall behind Wall Street projections. Gilead’s twice-yearly HIV pre-exposure prophylactic Yeztugo is likewise on track to miss the consensus forecast, according to Truist’s projections. On the company call, the firm wants to hear how Gilead is preparing for the launch of its next CAR T therapy, anito-cel, ahead of a potential approval later this year. The pharma is proposing anito-cel for multiple myeloma, with an FDA target action date of Dec. 23 . Mergers & acquisitions Gilead Doubles Down on CAR T With $7.8B Arcellx Acquisition The centerpiece of the takeover is anito-cel, a CAR T therapy under development for relapsed or refractory multiple myeloma. An FDA decision on the therapy is expected by December 2026. February 23, 2026 · 2 min read · Tristan Manalac Read more Looking ahead to the back half of the year, Truist anticipates a “robust catalyst calendar, supported by sector optimism and deal activity” across biopharma.

2026-07-02

·动脉网

到2036年，非小细胞肺癌市场在新兴靶向治疗和免疫疗法创新的推动下，预计将以6.6%的年均复合增长率强劲扩张 DelveInsightNon-Small Cell Lung Cancer Market Poised for Robust Expansion at a 6.6% CAGR Through 2036, Driven by Emerging Targeted and Immunotherapy Innovations

The non-small cell lung cancer market is experiencing robust growth, driven by the increasing incidence of lung cancer and continuous advancements in precision medicine. The introduction of targeted therapies, immune checkpoint inhibitors, and biomarker-driven treatment approaches has significantly improved patient outcomes and expanded treatment options. 非小细胞肺癌市场正经历强劲增长，这得益于肺癌发病率的不断上升以及精准医疗的持续进步。靶向疗法、免疫检查点抑制剂和基于生物标志物的治疗方法的引入，显著改善了患者预后并扩大了治疗选择。Additionally, the expected launch of emerging therapies such as BMS-986504 + Pembrolizumab (BMS), Iza-bren (izalontamab brengitecan) (SystImmune and Bristol Myers Squibb), Neladalkib (NVL-655) (Nuvalent), PF-08046054 (SGN-PDL1V) (Pfizer), and others will further propel the market growth.. 此外，BMS-986504联合帕博利珠单抗（百时美施贵宝）、Iza-bren（izalontamab brengitecan）（SystImmune与百时美施贵宝）、Neladalkib（NVL-655）（Nuvalent）、PF-08046054（SGN-PDL1V）（辉瑞）等新兴疗法的预期上市，将进一步推动市场增长。LAS VEGAS 拉斯维加斯, ，July 2, 2026 2026年7月2日/PRNewswire/ -- Recently published Non-small Cell Lung Cancer Market Insights report includes a comprehensive understanding of current treatment practices, non-small cell lung cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].. /美通社/ -- 最近发布的《非小细胞肺癌市场洞察》报告包括对当前治疗实践、非小细胞肺癌新兴药物、各疗法市场份额以及2022年至2036年当前和预测市场规模的全面理解，按主要市场（美国、欧盟四国（德国、法国、意大利和西班牙）、英国和日本）进行细分。Non-small Cell Lung Cancer Market Summary 非小细胞肺癌市场概览The market size for non-small cell lung cancer was found to be 非小细胞肺癌的市场规模被发现为USD 33 billion 330亿美元in the 7MM in 2025. 在2025年的7毫米口径中。The total market size of EGFR-mutated NSCLC in the US was nearly 美国EGFR突变非小细胞肺癌（NSCLC）的总体市场规模接近USD 3.8 billion 38亿美元in 2025. EGFR is one of the profitable biomarker segments, with blockbuster therapies such as TAGRISSO. TAGRISSO is now the dominant EGFR inhibitor. 2025年。EGFR是盈利的生物标志物细分领域之一，拥有TAGRISSO等重磅疗法。TAGRISSO目前是主导的EGFR抑制剂。The total market size of ALK-mutated NSCLC in the US was nearly 美国ALK突变型非小细胞肺癌（NSCLC）的总体市场规模接近USD 1.28 billion 12.8亿美元in 2025. In the adjuvant setting, ALECENSA has become the first approved ALK inhibitor following surgical resection, expanding treatment duration and increasing the addressable early-stage population. 2025年。在辅助治疗领域，ALECENSA已成为首个在手术切除后获批的ALK抑制剂，延长了治疗持续时间，并扩大了可治疗的早期患者人群。In 2025, the 7MM had approximately 2025年，7MM大约有539,000 539,000incident cases of NSCLC. These are expected to rise due to the growing incident population and advancements in diagnostic capabilities during the forecast period (2026−2036). 非小细胞肺癌（NSCLC）的新发病例。在预测期（2026−2036年）内，由于新发患者人群的增长以及诊断技术的进步，预计这些病例数将上升。Leading non-small cell lung cancer pharmaceutical companies, such as 领先的非小细胞肺癌制药公司，例如SystImmune, Bristol Myers Squibb, Nuvalent, AbbVie, Revolution Medicines, GSK, Compugen, BioNTech, Candel Therapeutics, OncoC4, BioNTech, Incyte, Macrogenics, Iovance Biotherapeutics, Hoffmann-La Roche, Genentech, Regeneron Pharmaceuticals, Kelun-Biotech, Immutep, Moderna Therapeutics, BeyondSpring, Cullinan Oncology, Eli Lilly and Company, OSE Immuno-therapeutics, Pfizer, ImmunityBio, Jiangsu HengRui Medicine, AstraZeneca, Arcus Biosciences, Gilead Sciences, Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals), ArriVent BioPharma, Shanghai Allist Pharmaceuticals, Innovent Biologics, Takeda Pharmaceutical, Apollomics, Avistone Biotechnology,. SystImmune、百时美施贵宝、Nuvalent、艾伯维、Revolution Medicines、葛兰素史克、Compugen、BioNTech、Candel Therapeutics、OncoC4、BioNTech、Incyte、MacroGenics、Iovance Biotherapeutics、霍夫曼-拉罗氏、基因泰克、再生元制药、科伦博泰、Immutep、Moderna Therapeutics、BeyondSpring、Cullinan Oncology、礼来公司、OSE Immuno-therapeutics、辉瑞、ImmunityBio、江苏恒瑞医药、阿斯利康、Arcus Biosciences、吉利德科学、默沙东、大冢制药（Taiho 和 Astex Pharmaceuticals）、ArriVent BioPharma、上海艾力斯医药、信达生物、武田制药、Apollomics、Avistone Biotechnology。and others, are developing new non-small cell lung cancer treatment drugs that can be available in the non-small cell lung cancer market in the coming years. 以及其他公司，正在开发新的非小细胞肺癌治疗药物，这些药物有望在未来几年内上市。The promising non-small cell lung cancer therapies in clinical trials include 临床试验中颇具前景的非小细胞肺癌疗法包括Iza-bren (izalontamab brengitecan), BMS-986504 + Pembrolizumab, Neladalkib (NVL-655), PF-08046054 (SGN-PDL1V), Telisotuzumab adizutecan, Temab-A (ABBV-400), Daraxonrasib (RMC-6236), ZEJULA (niraparib), Rilvegostomig (AZD2936), Pumitamig (BNT327/PM8002), CAN-2409 (aglatimagene besadenovec), Gotistobart (BNT316, ONC-392), ZYNYZ (retifanlimab-dlwr, INCMGA00012), LN-145, Divarasib (GDC-6036), Fianlimab (REGN3767), Sacituzumab tirumotecan (MK-2870/SKB264), Eftilagimod alpha, Intismeran autogene (mRNA-4157/V940), Plinabulin, Zipalertinib, Olomorasib, Ceralasertib, TEDOPI, Sigvotatug vedotin, ANKTIVA, Pyrotinib, Volrustomig, TRODELVY (sacituzumab govitecan), Domvanalimab + Combination Therapies, OPDUALAG (nivolumab and relatlimab), Calderasib (MK-1084), Firmonertinib, IBI363, Vebreltinib (APL-101), . 伊扎布伦（izalontamab brengitecan）、BMS-986504 + 帕博利珠单抗、内拉达尔基布（NVL-655）、PF-08046054（SGN-PDL1V）、泰利索珠单抗 adizutecan、Temab-A（ABBV-400）、达拉雄拉西布（RMC-6236）、ZEJULA（尼拉帕利）、瑞尔维戈斯托米格（AZD2936）、普米塔米格（BNT327/PM8002）、CAN-2409（aglatimagene besadenovec）、戈蒂斯托巴特（BNT316，ONC-392）、ZYNYZ（retifanlimab-dlwr，INCMGA00012）、LN-145、迪瓦拉西布（GDC-6036）、菲安利马单抗（REGN3767）、萨西妥珠单抗 tirumotecan（MK-2870/SKB264）、依夫替拉吉莫德α、英蒂斯美兰自基因（mRNA-4157/V940）、普利纳布林、齐帕替尼、奥洛莫拉西布、塞拉拉瑟替布、TEDOPI、西格沃塔图格维多汀、ANKTIVA、吡咯替尼、沃尔鲁斯托米格、TRODELVY（萨西妥珠单抗戈维替康）、多姆瓦那利马单抗 + 联合疗法、OPDUALAG（纳武利尤单抗和瑞拉利马单抗）、卡尔德拉西布（MK-1084）、菲尔莫奈替尼、IBI363、韦布替尼（APL-101）and others. 以及其他。Discover bispecific antibody treatments for EGFR-mutated non-small cell lung cancer @ 探索针对EGFR突变非小细胞肺癌的双特异性抗体疗法 @https://www.delveinsight.com/report-store/non-small-cell-lung-cancer-nsclc-market https://www.delveinsight.com/report-store/non-small-cell-lung-cancer-nsclc-marketKey Factors Driving the Growth of the Non-small Cell Lung Cancer Market 推动非小细胞肺癌市场增长的关键因素Rising NSCLC Incidence: 非小细胞肺癌发病率上升：Non-small cell lung cancer continues to represent a significant healthcare burden in the United States, although its incidence is showing signs of stabilization. This trend reflects the impact of sustained tobacco control efforts, which have contributed to a gradual decline in overall lung cancer rates, while broader adoption of low-dose CT screening and increased incidental detection through routine imaging have led to more diagnoses at earlier stages. 非小细胞肺癌在美国仍然构成重大的医疗负担，尽管其发病率已显现出稳定迹象。这一趋势反映了持续烟草控制措施的影响，这些措施促使整体肺癌发病率逐渐下降；同时，低剂量CT筛查的广泛普及以及常规影像学检查中偶然发现病例的增加，使得更多患者能够在早期阶段获得诊断。In 2025, the US recorded approximately 203,000 incident NSCLC cases, a figure projected to increase modestly to around 205,000 cases by 2036.. 2025年，美国记录的新发非小细胞肺癌（NSCLC）病例约为203,000例，预计到2036年将小幅增至约205,000例。Rising Opportunities in EGFR NSCLC Therapies: EGFR非小细胞肺癌治疗领域日益增长的机遇：In EGFR-mutated NSCLC, where Tagrisso continues to dominate the market, Rybrevant is steadily strengthening its position. The J&J therapy has expanded into the broader first-line EGFR-mutated NSCLC setting through its combination with the oral EGFR-TKI Lazcluze. Additionally, the company is pursuing the launch of a subcutaneous (SC) formulation of Rybrevant to further enhance patient convenience and treatment accessibility.. 在泰瑞沙持续主导市场的EGFR突变非小细胞肺癌领域，Rybrevant的市场地位正稳步增强。通过与口服EGFR-TKI药物Lazcluze联用，强生公司的该疗法已拓展至更广泛的一线EGFR突变非小细胞肺癌治疗场景。此外，该公司正推动Rybrevant皮下注射制剂的上市，以进一步提升患者便利性和治疗可及性。The Untapped Potential of Front-Line NSCLC Treatment: 一线非小细胞肺癌治疗的未开发潜力：Front-line NSCLC represents a large market, currently only being dominated by anti-PD1 drugs and anti-PD-1 + CTx combination, leaving a significant opportunity for therapy beyond anti-PD1 to deliver higher clinical benefit. 一线非小细胞肺癌（NSCLC）市场庞大，目前主要由抗PD-1药物及抗PD-1联合化疗（CTx）方案主导，这为超越抗PD-1的疗法提供了显著机会，以带来更高的临床获益。Robust NSCLC Clinical Trial Activities: 稳健的非小细胞肺癌临床试验活动：The NSCLC clinical trial landscape is robust with various candidates in late stage of development, including 非小细胞肺癌（NSCLC）临床试验格局强劲，有多种候选药物处于后期开发阶段，包括BMS-986504 + Pembrolizumab BMS-986504 + 帕博利珠单抗(BMS), （电池管理系统）Iza-bren (izalontamab brengitecan) 伊扎布伦（伊扎仑塔单抗布伦吉特康）(SystImmune and Bristol Myers Squibb), （SystImmune 和百时美施贵宝）Neladalkib (NVL-655) 奈拉达尔克布（NVL-655）(Nuvalent), （Nuvalent），PF-08046054 (SGN-PDL1V) PF-08046054（SGN-PDL1V）(Pfizer), （辉瑞）Telisotuzumab adizutecan, Temab-A (ABBV-400) 替利索珠单抗阿迪苏特康，Temab-A（ABBV-400）(AbbVie), （艾伯维）Daraxonrasib (RMC-6236) 达拉索拉西布（RMC-6236）(Revolution Medicines), (革命药物公司),ZEJULA (niraparib) 则杰拉（尼拉帕利）(GSK), （葛兰素史克）Rilvegostomig (AZD2936) Rilvegostomig（AZD2936）(AstraZeneca/Compugen), （阿斯利康/Compugen）Pumitamig (BNT327/PM8002) 普米塔米格（BNT327/PM8002）(BioNTech/BMS), （BioNTech/百时美施贵宝）CAN-2409 (aglatimagene besadenovec) CAN-2409（阿格拉蒂马基因贝萨多诺韦克）(Candel Therapeutics), and other. （Candel Therapeutics）及其他。Sadaf Javed, Functional Head, Forecasting at DelveInsight, said that the total market size of KRAS-mutated NSCLC in the US was nearly USD 2.23 billion in 2025. The most frequent KRAS variant in NSCLC is G12C. KRAS-mutated NSCLC represents a rapidly evolving and highly competitive market across 1L and 2L+ settings, driven by the shift from first-generation monotherapies to next-generation, combination-based strategies. DelveInsight 预测功能主管 Sadaf Javed 表示，2025 年美国 KRAS 突变非小细胞肺癌（NSCLC）的总体市场规模接近 22.3 亿美元。NSCLC 中最常见的 KRAS 变异是 G12C。KRAS 突变 NSCLC 市场在一线治疗和二线及以上治疗领域均呈现出快速演变和高度竞争的态势，这一趋势由从第一代单药疗法向新一代联合治疗策略的转变所驱动。In the 2L+ settings, approved agents such as LUMAKRAS (2021) and KRAZATI (2023) established the KRAS G12C class, with KRAZATI demonstrating slightly stronger competitive positioning.. 在二线及以上治疗（2L+）中，已获批的药物如LUMAKRAS（2021年）和KRAZATI（2023年）确立了KRAS G12C抑制剂这一类别，其中KRAZATI展现出略强的竞争优势。Non-small Cell Lung Cancer Market Analysis 非小细胞肺癌市场分析Real-world treatment patterns in non-small cell lung cancer have evolved considerably, with a clear transition from conventional systemic therapies to targeted treatments and immunotherapies, which now represent the primary drivers of therapeutic advancement. 非小细胞肺癌的真实世界治疗模式已发生显著演变，明显从传统全身性治疗转向靶向治疗和免疫治疗，后者如今已成为推动治疗进步的主要动力。However, a substantial proportion of NSCLC patients remain ineligible for targeted therapies due to the absence of actionable mutations. In these patients, PD-L1–directed therapies play a central role, with 然而，由于缺乏可靶向的突变，相当大比例的非小细胞肺癌（NSCLC）患者仍然无法接受靶向治疗。在这些患者中，针对PD-L1的治疗发挥着核心作用，Merck's KEYTRUDA 默沙东的KEYTRUDA, particularly in combination with platinum-based chemotherapy, continuing to serve as the standard first-line treatment irrespective of PD-L1 expression levels. ，尤其是与铂类化疗联合使用时，无论PD-L1表达水平如何，继续作为标准的一线治疗方案。A major challenge in the immunotherapy landscape is the development of acquired resistance to PD-1/PD-L1 inhibitors. As resistance emerges, many patients lose the clinical benefit of these agents and are often left with chemotherapy, which may offer limited efficacy and considerable toxicity. 免疫治疗领域面临的一个主要挑战是获得性耐药对PD-1/PD-L1抑制剂的发展。随着耐药性的出现，许多患者失去了这些药物的临床获益，往往只能接受化疗，而化疗可能疗效有限且毒性较大。This significant unmet need has prompted extensive research into novel therapeutic agents and combination regimens for patients with advanced NSCLC who have progressed following immunotherapy. 这一显著未满足的临床需求促使人们开展广泛研究，探索用于免疫治疗后进展的晚期非小细胞肺癌患者的新型治疗药物及联合方案。Among molecularly defined NSCLC subtypes, EGFR exon 20 insertion mutations have attracted significant attention in recent years, resulting in an increasingly competitive treatment landscape. 在分子定义的非小细胞肺癌（NSCLC）亚型中，EGFR 20号外显子插入突变近年来引起了广泛关注，导致治疗格局的竞争日益激烈。Beyond these alterations, uncommon EGFR mutations, including 除这些改变外，罕见的EGFR突变，包括G719X, S768I, and PACC variants G719X、S768I 和 PACC 变异, are emerging as important areas of clinical development and represent the next frontier for targeted therapies in EGFR-mutated NSCLC. ，正成为临床开发的重要领域，并代表了EGFR突变非小细胞肺癌靶向治疗的下一个前沿。In ALK-positive NSCLC, 在ALK阳性的非小细胞肺癌中，ALECENSA and ALUNBRIG 艾乐替尼和阿来替尼have become the preferred first-line tyrosine kinase inhibitors (TKIs), with ALECENSA maintaining a dominant position due to its broader clinical adoption. Before the introduction of these next-generation agents, 已成为首选的一线酪氨酸激酶抑制剂（TKI），其中阿来替尼凭借更广泛的临床应用而占据主导地位。在这些下一代药物问世之前，XALKORI 克唑替尼was the primary treatment option for ALK-rearranged disease. 是ALK重排疾病的主要治疗选择。KRAS-mutated NSCLC has also witnessed substantial progress, particularly for the KRAS G12C subtype, which represents the most common KRAS alteration in NSCLC. As multiple therapies now target this mutation, the G12C segment is becoming increasingly crowded and competitive. KRAS突变的非小细胞肺癌（NSCLC）也取得了显著进展，尤其是KRAS G12C亚型，这是NSCLC中最常见的KRAS变异。随着多种疗法现在针对这一突变，G12C领域正变得越来越拥挤和竞争激烈。Future growth opportunities are expected to arise from expanding treatment options in relapsed/refractory settings and advancing KRAS-targeted therapies into first-line treatment. 未来的增长机会预计将来自在复发/难治性环境中扩大治疗选择，以及将KRAS靶向疗法推进至一线治疗。The treatment landscape for rare NSCLC biomarkers remains less well-defined due to the low prevalence of these alterations and the limited availability of late-stage clinical evidence. 由于这些罕见非小细胞肺癌（NSCLC）生物标志物的发生率较低，且晚期临床证据有限，其治疗格局仍不够明确。Nevertheless, significant advancements have been achieved for rare molecular subsets such as ROS1 rearrangements, HER2 mutations, RET fusions, and NTRK gene fusions, leading to improved therapeutic options for these patient populations. 然而，在ROS1重排、HER2突变、RET融合和NTRK基因融合等罕见分子亚型方面已取得显著进展，从而为这些患者群体提供了更优的治疗选择。Despite remarkable progress in precision oncology and immunotherapy, early-stage NSCLC (Stages I–III) continues to represent a significant area of unmet need. Surgical resection followed by adjuvant platinum-based chemotherapy remains the standard of care but provides only modest survival benefits while exposing patients to substantial toxicity.. 尽管在精准肿瘤学和免疫治疗方面取得了显著进展，但早期非小细胞肺癌（I–III期）仍然代表着一个存在巨大未满足需求的重要领域。手术切除后辅以含铂辅助化疗仍是标准治疗方案，但其带来的生存获益有限，同时使患者面临显著的毒性反应。Although immunotherapeutic approaches, including PD-1/PD-L1 inhibitors and neoadjuvant chemo-immunotherapy regimens, have demonstrated encouraging improvements in event-free survival and pathological response rates, their integration into routine clinical practice is still evolving, with challenges related to accessibility, patient selection, and treatment personalization.. 尽管包括PD-1/PD-L1抑制剂和新辅助化疗免疫联合方案在内的免疫治疗方法，在无事件生存期和病理缓解率方面显示出令人鼓舞的改善，但其在常规临床实践中的整合仍在不断发展中，并面临与可及性、患者选择和治疗个体化相关的挑战。The dynamics of the NSCLC market are anticipated to change in the coming years owing to the improvement in the rise in healthcare spending across the world. Some of the key players in the pipeline include 预计未来几年，随着全球医疗保健支出的增加，非小细胞肺癌（NSCLC）市场的动态将发生变化。研发管线中的一些主要参与者包括Bristol Myers Squibb, SystImmune, Nuvalent, Pfizer, AbbVie, Revolution Medicines, GSK, AstraZeneca, Compugen, BioNTech, Candel Therapeutics, OncoC4, Incyte, Macrogenics, Iovance Biotherapeutics, Hoffmann-La Roche, Genentech, Regeneron Pharmaceuticals 百时美施贵宝、SystImmune、Nuvalent、辉瑞、艾伯维、Revolution Medicines、葛兰素史克、阿斯利康、Compugen、BioNTech、Candel Therapeutics、OncoC4、Incyte、MacroGenics、Iovance Biotherapeutics、罗氏、基因泰克、再生元制药, and others are involved in developing drugs for NSCLC. ，其他机构也参与了非小细胞肺癌（NSCLC）药物的研发。Non-small Cell Lung Cancer Competitive Landscape 非小细胞肺癌竞争格局Some of the NSCLC drugs under late stage of development include 处于后期开发阶段的非小细胞肺癌药物包括BMS-986504 + Pembrolizumab BMS-986504 + 帕博利珠单抗(BMS), （电池管理系统）Iza-bren (izalontamab brengitecan) 伊扎布伦（伊扎仑塔单抗布伦吉替康）(SystImmune and Bristol Myers Squibb), （SystImmune 和百时美施贵宝）Neladalkib (NVL-655) 奈拉达尔克（NVL-655）(Nuvalent), (Nuvalent),PF-08046054 (SGN-PDL1V) PF-08046054（SGN-PDL1V）(Pfizer), （辉瑞）Telisotuzumab adizutecan, Temab-A (ABBV-400) 泰利索妥珠单抗阿迪祖替康，Temab-A（ABBV-400）(AbbVie), （艾伯维）Daraxonrasib (RMC-6236) 达拉松拉西布（RMC-6236）(Revolution Medicines), （革命医药公司）ZEJULA (niraparib) 泽杰拉（尼拉帕利）(GSK), （葛兰素史克）Rilvegostomig (AZD2936) Rilvegostomig（AZD2936）(AstraZeneca/Compugen), （阿斯利康/Compugen）Pumitamig (BNT327/PM8002) 普米塔米格（BNT327/PM8002）(BioNTech/BMS), （BioNTech/百时美施贵宝）CAN-2409 (aglatimagene besadenovec) CAN-2409（阿格拉蒂马基因贝萨多诺韦克）(Candel Therapeutics), （Candel Therapeutics），Gotistobart (BNT316, ONC-392) 戈替斯托巴特（BNT316，ONC-392）(OncoC4/BioNTech), （OncoC4/百欧恩泰）ZYNYZ (retifanlimab-dlwr, INCMGA00012) ZYNYZ（retifanlimab-dlwr，INCMGA00012）(Incyte/Macrogenics), （Incyte/Macrogenics），LN-145 LN-145(Iovance Biotherapeutics), （Iovance Biotherapeutics）Divarasib (GDC-6036) 迪瓦拉西布（GDC-6036）(Hoffmann-La Roche/Genentech), （霍夫曼-拉罗氏/基因泰克）Fianlimab (REGN3767) 菲安利单抗（REGN3767）(Regeneron Pharmaceuticals), （再生元制药公司）Sacituzumab tirumotecan (MK-2870/SKB264) 萨西妥珠单抗替鲁特康（MK-2870/SKB264）(Merck and Kelun-Biotech), （默克和科伦博泰）Eftilagimod alpha 依夫替莫德α(Immutep), (Immutep)Intismeran autogene (mRNA-4157/ V940) Intismeran autogene（mRNA-4157/V940）(Moderna Therapeutics and Merck), （莫德纳治疗公司和默克公司）Plinabulin 普利纳布林(BeyondSpring), （BeyondSpring），Zipalertinib 齐帕雷替尼(Cullinan Oncology/Taiho Pharma), （Cullinan Oncology/大正制药）Olomorasib 奥洛莫拉西布(Eli Lilly and Company), （礼来公司）Ceralasertib 塞拉拉斯替布(AstraZeneca), （阿斯利康），TEDOPI OSE TEDOPI OSE(Immuno-therapeutics), （免疫治疗药物）Sigvotatug vedotin 西格沃塔图格·韦多廷(Pfizer), （辉瑞）ANKTIVA 安科蒂瓦(ImmunityBio), （ImmunityBio）Pyrotinib 吡咯替尼(Jiangsu HengRui Medicine), （江苏恒瑞医药）Volrustomig 沃尔鲁斯托米格(AstraZeneca), （阿斯利康）TRODELVY (sacituzumab govitecan) 特罗德尔维（戈沙妥珠单抗）(Gilead Sciences), （吉利德科学公司）Domvanalimab + Combination Therapies 多姆瓦那利单抗 + 联合疗法(Arcus Biosciences/Gilead Sciences), （Arcus Biosciences/吉利德科学）OPDUALAG (nivolumab and relatlimab) OPDUALAG（纳武利尤单抗和瑞拉利珠单抗）(Bristol Myers Squibb), （百时美施贵宝）Calderasib (MK-1084) 卡尔德拉西布（MK-1084）[Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals)], [默克、大冢制药（Taiho 和 Astex Pharmaceuticals）]，Firmonertinib 非莫替尼(ArriVent BioPharma/Shanghai Allist Pharmaceuticals), （ArriVent BioPharma/上海艾力斯医药）IBI363 IBI363(Innovent Biologics and Takeda Pharmaceutical), （信达生物和武田制药），Vebreltinib (APL-101) 韦布替尼（APL-101）(Apollomics and Avistone Biotechnology), and others. （阿波罗米克斯和艾维斯通生物技术）等。Immutep's Eftilagimod alpha Immutep 公司的 Eftilagimod alphais a recombinant soluble protein composed of a dimeric form of LAG-3 that has been engineered to circulate freely rather than remain attached to the cell surface. As a first-in-class activator of antigen-presenting cells (APCs), it enhances immune system activity and has demonstrated the ability to generate durable immune responses in cancer patients. 是一种重组可溶性蛋白，由经工程化改造的二聚体LAG-3组成，使其能够在体内自由循环，而非锚定在细胞表面。作为首创的抗原呈递细胞（APC）激活剂，它能够增强免疫系统活性，并已在癌症患者中展现出诱导持久免疫反应的能力。The therapy can be administered at lower doses as an adjuvant to cancer vaccines or at higher doses to achieve broader systemic activation of APCs.. 该疗法可以作为癌症疫苗的辅助治疗以较低剂量给药，或以较高剂量给药以实现对抗原呈递细胞（APCs）更广泛的全身激活。Nuvalent's Neladalkib Nuvalent公司的Neladalkibis an advanced, brain-penetrant ALK inhibitor with high selectivity, developed to effectively target ALK resistance mutations while minimizing central nervous system toxicities associated with TRK inhibition. Created by Nuvalent for the treatment of ALK-driven malignancies, the therapy is designed to address resistance mechanisms and offer improved tolerability. 是一种先进的、能够穿透血脑屏障的ALK抑制剂，具有高选择性，旨在有效靶向ALK耐药突变，同时最大限度地减少与TRK抑制相关的中枢神经系统毒性。该疗法由Nuvalent公司开发，用于治疗ALK驱动的恶性肿瘤，旨在应对耐药机制并提供更好的耐受性。It is currently undergoing clinical investigation.. 目前正在接受临床研究。Revolution Medicines' Daraxonrasib (RMC-6236) Revolution Medicines 公司的 Daraxonrasib（RMC-6236）is an orally administered, multi-selective inhibitor that directly targets the active RAS(ON) state, enabling broad applicability across cancers driven by RAS mutations. By preventing activated RAS proteins from interacting with downstream signaling effectors, it disrupts key pathways responsible for tumor growth and survival. 是一种口服的多选择性抑制剂，直接靶向活性RAS（ON）状态，从而在由RAS突变驱动的多种癌症中具有广泛的适用性。通过阻止活化的RAS蛋白与下游信号效应因子相互作用，它破坏了负责肿瘤生长和存活的关键通路。The drug is active against several oncogenic RAS variants, including G12X, G13X, and Q61X mutations, which are frequently observed in cancers such as non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC).. 该药物对多种致癌性RAS变异体具有活性，包括在非小细胞肺癌（NSCLC）、胰腺导管腺癌（PDAC）和结直肠癌（CRC）等癌症中常见的G12X、G13X和Q61X突变。Iovance Biotherapeutics' LN-145 Iovance Biotherapeutics 公司的 LN-145is an autologous tumor-infiltrating lymphocyte (TIL) therapy that harnesses a patient's own immune cells to combat cancer. The treatment is produced by isolating T cells from a patient's tumor tissue and expanding them outside the body before reinfusion. A related product, LN-145-S1, is manufactured through an enhanced process that selectively enriches a specific subset of T cells, potentially improving therapeutic activity.. 是一种自体肿瘤浸润淋巴细胞（TIL）疗法，利用患者自身的免疫细胞来对抗癌症。该治疗方案通过从患者的肿瘤组织中分离T细胞，在体外进行扩增后再回输到患者体内。一款相关产品LN-145-S1则通过一种增强工艺生产，该工艺可选择性地富集特定亚群的T细胞，从而可能提高治疗活性。The anticipated launch of these emerging therapies are poised to transform the non-small cell lung cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the non-small cell lung cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.. 这些新兴疗法的预期上市将在未来几年内改变非小细胞肺癌市场的格局。随着这些前沿疗法不断成熟并获得监管批准，预计它们将重塑非小细胞肺癌市场格局，提供新的治疗标准，并为医疗创新和经济增长带来机遇。Discover more about non-small cell lung cancer PD-L1 inhibitors competitors 2026 @ 深入了解2026年非小细胞肺癌PD-L1抑制剂竞争格局 @Non-small Cell Lung Cancer Therapeutics Market 非小细胞肺癌治疗药物市场Recent Developments in the Non-small Cell Lung Cancer Market 非小细胞肺癌市场的最新进展In 在June 2026, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 2026年6月，四川科伦博泰生物医药股份有限公司announced the online publication of translational research findings in the international journal Cancer Cell, highlighting the use of sacituzumab tirumotecan in combination with osimertinib as a first-line therapy for patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). 宣布在国际期刊《癌症细胞》（Cancer Cell）在线发表转化研究成果，重点介绍了萨西妥珠单抗替鲁特康联合奥希替尼作为晚期EGFR突变非小细胞肺癌（NSCLC）患者的一线治疗方案。In 在June 2026, MAIA Biotechnology 2026年6月，MAIA生物技术公司announced the activation of Winship Cancer Institute of Emory University as the third U.S. site in its Phase 2 THIO-101 expansion trial. The study is enrolling patients to assess ateganosine as a third-line therapy for non-small cell lung cancer (NSCLC). 宣布启动埃默里大学温希普癌症研究所作为其THIO-101二期扩展试验的第三个美国站点。该研究正在招募患者，以评估阿替加诺辛作为非小细胞肺癌（NSCLC）三线疗法的疗效。In 在May 2026, Bristol Myers Squibb (BMS) and its partner BioNTech 2026年5月，百时美施贵宝（BMS）及其合作伙伴BioNTechunveiled interim Phase II findings from the global Phase II/III ROSETTA Lung-02 trial (NCT06712316) at ASCO 2026, evaluating the PD-L1/VEGF bispecific antibody pumitamig in combination with chemotherapy as a first-line treatment for patients with previously untreated non-small cell lung cancer (NSCLC).. 在2026年美国临床肿瘤学会（ASCO）年会上，公布了全球II/III期ROSETTA Lung-02试验（NCT06712316）的II期中期结果，该研究评估了PD-L1/VEGF双特异性抗体pumitamig联合化疗作为既往未经治疗的非小细胞肺癌（NSCLC）患者一线治疗的疗效。In 在May 2026, Nuvation Bio 2026年5月，Nuvation Bioentered into a strategic collaboration with Thermo Fisher Scientific for the U.S.-based manufacturing of ibtrozi, an investigational drug targeting ROS1-positive non-small cell lung cancer (NSCLC). 与赛默飞世尔科技达成战略合作，在美国本土生产靶向ROS1阳性非小细胞肺癌（NSCLC）的在研药物ibtrozi。In 在May 2026, Innovent Biologics, Inc. 2026年5月，信达生物制药公司reported preliminary findings from a proof-of-concept (PoC) clinical study evaluating its first-in-class global PD-1/IL-2α-biased bispecific fusion protein, IBI363 (Takeda R&D code: TAK-928), in combination with chemotherapy for the first-line treatment of advanced non-small cell lung cancer (NSCLC). 报告了一项概念验证（PoC）临床研究的初步结果，该研究评估了其首创的全球性PD-1/IL-2α偏向性双特异性融合蛋白IBI363（武田研发代码：TAK-928）联合化疗用于晚期非小细胞肺癌（NSCLC）一线治疗的疗效。The results were presented at the 2026 ASCO Annual Meeting.. 这些结果在2026年美国临床肿瘤学会（ASCO）年会上进行了展示。In 在May 2026, Dizal 2026年5月，Dizalshared findings from two non-small cell lung cancer (NSCLC) studies at the 2026 ASCO Annual Meeting. One study highlighted the investigational fourth-generation EGFR tyrosine kinase inhibitor (TKI), DZD6008, in previously treated NSCLC patients harboring EGFR C797X mutations after disease progression on third-generation EGFR TKIs, with results presented during an oral session. 在2026年美国临床肿瘤学会（ASCO）年会上分享了两项非小细胞肺癌（NSCLC）研究的结果。其中一项研究重点介绍了 investigational 第四代表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）DZD6008，用于既往接受过治疗、且在第三代EGFR TKI治疗后出现疾病进展并携带EGFR C797X突变的NSCLC患者，相关结果在口头报告环节公布。The second study reported outcomes of golidocitinib, a selective JAK1 inhibitor, used in combination with an anti-PD-1 antibody as a first-line therapy for patients with PD-L1-positive advanced NSCLC lacking driver mutations.. 第二项研究报告了选择性JAK1抑制剂戈利昔替尼联合抗PD-1抗体作为一线疗法，用于缺乏驱动基因突变的PD-L1阳性晚期非小细胞肺癌（NSCLC）患者的治疗结果。What is Non-small Cell Lung Cancer? 什么是非小细胞肺癌？Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases. It is a heterogeneous group of malignancies that originate from the epithelial cells of the lung and includes several histological subtypes, primarily adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. 非小细胞肺癌（NSCLC）是最常见的肺癌类型，约占所有肺癌病例的85%。它是一组起源于肺上皮细胞的异质性恶性肿瘤，包括多种组织学亚型，主要为腺癌、鳞状细胞癌和大细胞癌。NSCLC typically grows and spreads more slowly than small cell lung cancer (SCLC), although disease progression can vary depending on the tumor subtype and molecular characteristics. Major risk factors include tobacco smoking, exposure to environmental carcinogens such as radon and asbestos, air pollution, and certain genetic predispositions. 非小细胞肺癌（NSCLC）的生长和扩散速度通常慢于小细胞肺癌（SCLC），尽管疾病进展可能因肿瘤亚型和分子特征而异。主要风险因素包括吸烟、接触氡和石棉等环境致癌物、空气污染以及某些遗传易感性。Advances in molecular diagnostics have identified key genetic alterations, including mutations in EGFR, ALK, ROS1, KRAS, and other oncogenic drivers, enabling the development of targeted therapies and immunotherapies that have significantly improved treatment outcomes for patients with advanced disease.. 分子诊断技术的进步已识别出关键的基因改变，包括EGFR、ALK、ROS1、KRAS及其他致癌驱动基因的突变，从而推动了靶向治疗和免疫治疗的发展，显著改善了晚期疾病患者的治疗结局。Non-small Cell Lung Cancer Epidemiology Segmentation 非小细胞肺癌流行病学细分The non-small cell lung cancer epidemiology section provides insights into the historical and current non-small cell lung cancer patient pool and forecasted trends for the leading markets. Among the 7MM, the US accounted for the highest incident cases of NSCLC in 2025. This was followed by Japan, whereas the least number of cases were accounted by Spain.. 非小细胞肺癌流行病学部分提供了对主要市场历史及当前非小细胞肺癌患者群体规模以及预测趋势的洞察。在七大主要市场（7MM）中，美国在2025年记录的非小细胞肺癌新发病例数最多，其次是日本，而西班牙的新发病例数最少。The non-small cell lung cancer treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into: 非小细胞肺癌治疗市场报告提供了2022年至2036年研究期间主要市场的流行病学分析，细分如下：Total Incident Cases of NSCLC 非小细胞肺癌总发病病例数Gender-specific Cases of NSCLC 非小细胞肺癌的性别特异性病例Age-specific Cases of NSCLC 非小细胞肺癌的年龄特异性病例Total Incident Cases of NSCLC by Histology 按组织学分类的非小细胞肺癌总发病病例数Total Incident Cases of NSCLC by Stage 按分期划分的非小细胞肺癌总发病病例数Total Incident Cases of NSCLC by Genetic Mutations/Biomarkers 按基因突变/生物标志物分类的非小细胞肺癌（NSCLC）总发病病例数Patient Seeking Treatment for NSCLC 寻求非小细胞肺癌治疗的患者Line-wise Treated Cases of Metastatic NSCLC 按治疗线数划分的转移性非小细胞肺癌病例Non-small Cell Lung Cancer Market Report Metrics 非小细胞肺癌市场报告指标Details 详细信息Study Period 学习阶段2022–2036 2022–2036Coverage 覆盖范围7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. 7国集团（美国、欧盟四国（德国、法国、意大利和西班牙）、英国和日本）。Non-small Cell Lung Cancer Market CAGR 非小细胞肺癌市场复合年增长率6.6% 6.6%Non-small Cell Lung Cancer Market Size in 2025 2025年非小细胞肺癌市场规模USD 33 Billion 330亿美元Key Non-small Cell Lung Cancer Companies 关键非小细胞肺癌公司SystImmune, Bristol Myers Squibb, Nuvalent, AbbVie, Revolution Medicines, GSK, Compugen, BioNTech, Candel Therapeutics, OncoC4, BioNTech, Incyte, Macrogenics, Iovance Biotherapeutics, Hoffmann-La Roche, Genentech, Regeneron Pharmaceuticals, Kelun-Biotech, Immutep, Moderna Therapeutics, BeyondSpring, Cullinan Oncology, Eli Lilly and Company, OSE Immuno-therapeutics, Pfizer, ImmunityBio, Jiangsu HengRui Medicine, AstraZeneca, Arcus Biosciences, Gilead Sciences, Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals), ArriVent BioPharma, Shanghai Allist Pharmaceuticals, Innovent Biologics, Takeda Pharmaceutical, Apollomics, Avistone Biotechnology, Boehringer Ingelheim, Hansoh Pharma, Dizal (Jiangsu) Pharmaceutical, Johnson & Johnson Innovative Medicine (Janssen), and others. SystImmune、百时美施贵宝、Nuvalent、艾伯维、Revolution Medicines、葛兰素史克、Compugen、BioNTech、Candel Therapeutics、OncoC4、BioNTech、Incyte、MacroGenics、Iovance Biotherapeutics、霍夫曼-拉罗氏、基因泰克、再生元制药、科伦博泰、Immutep、Moderna Therapeutics、BeyondSpring、Cullinan Oncology、礼来公司、OSE Immuno-therapeutics、辉瑞、ImmunityBio、江苏恒瑞医药、阿斯利康、Arcus Biosciences、吉利德科学、默克、大冢制药（Taiho 和 Astex Pharmaceuticals）、ArriVent BioPharma、上海艾力斯医药、信达生物、武田制药、Apollomics、Avistone Biotechnology、勃林格殷格翰、翰森制药、迪哲（江苏）医药、强生创新药（杨森）等。Key Non-small Cell Lung Cancer Therapies 关键非小细胞肺癌疗法Iza-bren (izalontamab brengitecan), BMS-986504 + Pembrolizumab, Neladalkib (NVL-655), PF-08046054 (SGN-PDL1V), Telisotuzumab adizutecan, Temab-A (ABBV-400), Daraxonrasib (RMC-6236), ZEJULA (niraparib), Rilvegostomig (AZD2936), Pumitamig (BNT327/PM8002), CAN-2409 (aglatimagene besadenovec), Gotistobart (BNT316, ONC-392), ZYNYZ (retifanlimab-dlwr, INCMGA00012), LN-145, Divarasib (GDC-6036), Fianlimab (REGN3767), Sacituzumab tirumotecan (MK-2870/SKB264), Eftilagimod alpha, Intismeran autogene (mRNA-4157/V940), Plinabulin, Zipalertinib, Olomorasib, Ceralasertib, TEDOPI, Sigvotatug vedotin, ANKTIVA, Pyrotinib, Volrustomig, TRODELVY (sacituzumab govitecan), Domvanalimab + Combination Therapies, OPDUALAG (nivolumab and relatlimab), Calderasib (MK-1084), Firmonertinib, IBI363, Vebreltinib (APL-101), TAGRISSO, GILOTRIF/GIOTRIF, VIZIMPRO, EXKIVITY, AUMSEQA, ZEGFROVY, RYBREVANT, DATROWAY, PORTRAZZA, KEYTRUDA, OPDIVO and others. 伊扎布伦（izalontamab brengitecan）、BMS-986504 + 帕博利珠单抗、奈拉达尔基布（NVL-655）、PF-08046054（SGN-PDL1V）、泰利索妥珠单抗 adizutecan、Temab-A（ABBV-400）、达拉雄拉西布（RMC-6236）、ZEJULA（尼拉帕利）、Rilvegostomig（AZD2936）、Pumitamig（BNT327/PM8002）、CAN-2409（aglatimagene besadenovec）、Gotistobart（BNT316，ONC-392）、ZYNYZ（retifanlimab-dlwr，INCMGA00012）、LN-145、Divarasib（GDC-6036）、Fianlimab（REGN3767）、Sacituzumab tirumotecan（MK-2870/SKB264）、eftilagimod alpha、Intismeran autogene（mRNA-4157/V940）、Plinabulin、Zipalertinib、Olomorasib、Ceralasertib、TEDOPI、Sigvotatug vedotin、ANKTIVA、Pyrotinib、Volrustomig、TRODELVY（sacituzumab govitecan）、Domvanalimab + 联合疗法、OPDUALAG（纳武利尤单抗和 relatlimab）、Calderasib（MK-1084）、Firmonertinib、IBI363、Vebreltinib（APL-101）、TAGRISSO、GILOTRIF/GIOTRIF、VIZIMPRO、EXKIVITY、AUMSEQA、ZEGFROVY、RYBREVANT、DATROWAY、PORTRAZZA、KEYTRUDA、OPDIVO 等。Scope of the 范围Non-small Cell Lung Cancer 非小细胞肺癌Market Report 市场报告Non-small Cell Lung Cancer Patient Population Forecast 非小细胞肺癌患者人群预测Non-small Cell Lung Cancer Therapeutics Market Size 非小细胞肺癌治疗药物市场规模Non-small Cell Lung Cancer Pipeline Analysis 非小细胞肺癌在研管线分析Non-small Cell Lung Cancer Market Size and Trends 非小细胞肺癌市场规模及趋势Non-small Cell Lung Cancer Market Opportunity 非小细胞肺癌市场机遇Non-small Cell Lung Cancer Market Unmet Needs 非小细胞肺癌市场未满足的需求KOL's Views on Non-small Cell Lung Cancer 关键意见领袖对非小细胞肺癌的观点Non-small Cell Lung Cancer Market Access and Reimbursement 非小细胞肺癌的市场准入与报销Download the report to understand the first-line treatment of advanced non-small cell lung cancer @ 下载报告以了解晚期非小细胞肺癌的一线治疗方案 @Non-small Cell Lung Cancer Pharmaceutical Company 非小细胞肺癌制药公司Table of Contents 目录1 1Non-small Cell Lung Cancer Market Key Insights 非小细胞肺癌市场关键洞察2 2Non-small Cell Lung Cancer Market Report Introduction 非小细胞肺癌市场报告简介3 3Key Highlights 核心亮点4 4Executive Summary 执行摘要5 5Key Events 关键事件6 6Epidemiology and Market Forecast Methodology of NSCLC 非小细胞肺癌的流行病学与市场预测方法学7 7NSCLC Market Overview at a Glance 非小细胞肺癌市场概览7.1 7.1Emerging Landscape Analysis in the 7MM (by Phase) 七大主要市场（按阶段划分）的新兴格局分析7.2 7.2Market Share of NSCLC by Biomarker (%) in the 7MM in 2025 2025年七国市场（7MM）中按生物标志物划分的非小细胞肺癌（NSCLC）市场份额（%）7.3 7.3Market Share of NSCLC by Biomarker (%) in the 7MM in 2036 2036年七大主要市场（7MM）中按生物标志物划分的非小细胞肺癌（NSCLC）市场份额（%）8 8Disease Background and Overview of NSCLC 疾病背景及非小细胞肺癌概述8.1 8.1Introduction 引言8.2 8.2Disease Biology: NSCLC 疾病生物学：非小细胞肺癌8.3 8.3Diagnosis 诊断9 9Current Treatment Practices: NSCLC 当前治疗实践：非小细胞肺癌9.1 9.1Treatment Algorithm 治疗算法9.2 9.2Treatment Guidelines and Recommendations for NSCLC 非小细胞肺癌的治疗指南与建议10 10Epidemiology and Patient Population 流行病学与患者人群10.1 10.1Key Findings 主要发现10.2 10.2Assumptions and Rationale 假设与理由10.3 10.3Total Incident Cases of NSCLC in the 7MM 7MM国家非小细胞肺癌（NSCLC）的总发病病例数10.4 10.4United States 美国10.4.1 10.4.1Total Incident Cases of NSCLC in the United States 美国非小细胞肺癌的总发病病例数10.4.2 10.4.2Gender-specific Cases of NSCLC in the United States 美国非小细胞肺癌的性别特异性病例10.4.3 10.4.3Age-specific Cases of NSCLC in the United States 美国非小细胞肺癌的年龄别病例数10.4.4 10.4.4Total Incident Cases of NSCLC by Histology in the United States 美国按组织学分类的非小细胞肺癌总发病病例数10.4.5 10.4.5Total Incident Cases of NSCLC by Stage in the United States 美国按分期统计的非小细胞肺癌总发病病例数10.4.6 10.4.6Total Cases of NSCLC by Genetic Mutations/Biomarkers in the United States 美国按基因突变/生物标志物划分的非小细胞肺癌病例总数10.4.7 10.4.7Patient Seeking Treatment for NSCLC in the United States 在美国寻求非小细胞肺癌治疗的患者10.4.8 10.4.8Line-wise Treated Cases of NSCLC in the United States 美国非小细胞肺癌按治疗线数统计的病例数10.5 10.5EU4 and the UK 欧盟4国与英国10.6 10.6Japan 日本11 十一Patient Journey 患者旅程12 12Key Endpoints in NSCLC 非小细胞肺癌的关键终点13 13Marketed NSCLC Therapies 已上市的非小细胞肺癌治疗药物13.1 13.1Competitive Landscape 竞争格局13.1.1 13.1.1Regulatory Approval History Across the 7MM 7MM国家的监管审批历史13.2 13.2EGFR Mutations EGFR突变13.2.1 13.2.1AUMSEQA (Aumolertinib): Jiangsu Hansoh Pharmaceutical AUMSEQA（阿美替尼）：江苏豪森药业13.2.1.1 13.2.1.1Product Description 产品描述13.2.1.2 13.2.1.2Regulatory Milestones 监管里程碑13.2.1.3 13.2.1.3Other Developmental Activity 其他发展性活动13.2.1.4 13.2.1.4Summary of Pivotal Clinical Trial 关键性临床试验总结13.2.2 13.2.2VIZIMPRO (Dacomitinib): Pfizer VIZIMPRO（达可替尼）：辉瑞13.2.3 13.2.3GILOTRIF/GIOTRIF (Afatinib maleate): Boehringer Ingelheim 吉洛特瑞夫/吉奥特瑞夫（马来酸阿法替尼）：勃林格殷格翰13.2.4 13.2.4TAGRISSO (Osimertinib): AstraZeneca 泰瑞沙（奥希替尼）：阿斯利康13.2.5 13.2.5PORTRAZZA (Necitumumab): Eli Lilly and Company PORTRAZZA（耐昔妥珠单抗）：礼来公司13.2.6 13.2.6RYBREVANT (Amivantamab) ± LAZCLUZE (Lazertinib): Johnson & Johnson Innovative Medicine/Yuhan Corporation RYBREVANT（埃万妥单抗）± LAZCLUZE（拉泽替尼）：强生创新医药/柳韩公司13.2.7 13.2.7ZEGFROVY (Sunvozertinib): Dizal Pharmaceutical ZEGFROVY（舒沃替尼）：迪哲医药13.2.8 13.2.8DATROWAY (Datopotamab Deruxtecan): Daiichi Sankyo/AstraZeneca DATROWAY（德曲妥珠单抗）：第一三共/阿斯利康13.3 13.3PD-1 Inhibitors PD-1抑制剂13.3.1 13.3.1OPDIVO (Nivolumab): Bristol Myers Squibb/Ono Pharmaceutical 欧狄沃（纳武利尤单抗）：百时美施贵宝/小野制药13.3.2 13.3.2KEYTRUDA (Pembrolizumab): Merck KEYTRUDA（帕博利珠单抗）：默克公司13.3.3 13.3.3LIBTAYO (Cemiplimab): Regeneron/Sanofi LIBTAYO（西米普利单抗）：再生元/赛诺菲13.3.4 13.3.4TEVIMBRA (Tislelizumab): BeiGene 替雷利珠单抗（TEVIMBRA）：百济神州13.3.5 13.3.5IMFINZI (Durvalumab) + IMJUDO (Tremelimumab): AstraZeneca IMFINZI（度伐利尤单抗）+ IMJUDO（曲美木单抗）：阿斯利康13.3.6 13.3.6CEJEMLY (Sugemalimab): CStone Pharmaceuticals CEJEMLY（舒格利单抗）：基石药业13.3.7 13.3.7IMFINZI (Durvalumab): AstraZeneca IMFINZI（度伐利尤单抗）：阿斯利康13.3.8 13.3.8TECENTRIQ (Atezolizumab): Genentech/Roche 泰圣奇（阿替利珠单抗）：基因泰克/罗氏13.4 13.4Other Mutations 其他突变13.4.1 13.4.1LORBRENA/LORVIQUA (Lorlatinib): Pfizer LORBRENA/LORVIQUA（洛拉替尼）：辉瑞13.4.2 13.4.2ENSACOVE (Ensartinib): Betta Pharmaceuticals/Xcovery 恩沙替尼（Ensartinib）：贝达药业/Xcovery13.4.3 13.4.3ALUNBRIG (Brigatinib): Takeda Pharmaceuticals ALUNBRIG（布格替尼）：武田制药13.4.4 13.4.4AUGTYRO (Repotrectinib): BMS AUGTYRO（瑞波替尼）：百时美施贵宝13.4.5 13.4.5ALECENSA (Alectinib): Roche/Chugai Pharmaceutical 艾乐替尼（Alectinib）：罗氏/中外制药13.4.6 13.4.6ROZLYTREK (Entrectinib): Roche (Genentech) 罗扎特雷克（恩曲替尼）：罗氏（基因泰克）13.4.7 13.4.7IBTROZI (Taletrectinib): Nuvation Bio IBTROZI（他雷替尼）：Nuvation Bio13.4.8 13.4.8GAVRETO (Pralsetinib): Blueprint Medicines/Rigel Pharmaceuticals GAVRETO（普拉替尼）：Blueprint Medicines/Rigel Pharmaceuticals13.4.9 13.4.9RETEVMO/RETSEVMO (Selpercatinib): Eli Lilly and Company RETEVMO/RETSEVMO（塞尔帕替尼）：礼来公司13.4.10 13.4.10TEPMETKO (Tepotinib): EMD Serono (Merck KGaA) TEPMETKO（特泊替尼）：EMD Serono（默克 KGaA）13.4.11 13.4.11HAIYITAN (Gumarontinib): Haihe Biopharma and Taiho Pharmaceutical 海益坦（古玛罗替尼）：海河生物制药与泰和制药13.4.12 13.4.12TABRECTA (Capmatinib): Novartis TABRECTA（卡马替尼）：诺华13.4.13 13.4.13LUMAKRAS/LUMYKRAS (Sotorasib): Amgen LUMAKRAS/LUMYKRAS（索托拉西布）：安进13.4.14 13.4.14KRAZATI (Adagrasib): BMS KRAZATI（阿达格拉西布）：百时美施贵宝13.4.15 13.4.15ENHERTU (Trastuzumab deruxtecan): Daiichi Sankyo /AstraZeneca ENHERTU（德曲妥珠单抗）：第一三共/阿斯利康13.4.16 13.4.16TAFINLAR (Dabrafenib) + MEKINIST (Trametinib): Novartis TAFINLAR（达拉非尼）+ MEKINIST（曲美替尼）：诺华13.4.17 13.4.17BRAFTOVI (Encorafenib) + MEKTOVI (Binimetinib): Pfizer/Pierre Fabre BRAFTOVI（康奈非尼）+ MEKTOVI（比美替尼）：辉瑞/皮埃尔法布雷13.4.18 13.4.18VITRAKVI (Larotrectinib): Bayer VITRAKVI（拉罗替尼）：拜耳13.4.19 13.4.19EMRELIS (Telisotuzumab vedotin-tllv): AbbVie EMRELIS（Telisotuzumab vedotin-tllv）：艾伯维13.4.20 13.4.20BIZENGRI (Zenocutuzumab): Merus and Partner Therapeutics BIZENGRI（泽诺库妥珠单抗）：Merus 与 Partner Therapeutics13.4.21 13.4.21HYRNUO (Sevabertinib): Bayer HYRNUO（塞瓦伯替尼）：拜耳13.4.22 13.4.22HERNEXEOS (Zongertinib): Boehringer Ingelheim HERNEXEOS（宗格替尼）：勃林格殷格翰14 十四Emerging NSCLC Therapies 新兴的非小细胞肺癌疗法14.1 14.1Competitive Landscape 竞争格局14.2 14.2Ateganosine: MAIA Biotechnology 阿替加诺辛：MAIA生物技术公司14.2.1 14.2.1Product Description 产品描述14.2.2 14.2.2Other Developmental Activities 其他发展活动14.2.3 14.2.3Clinical Development 临床开发14.2.3.1 14.2.3.1Clinical Trials Information 临床试验信息14.2.4 14.2.4Safety and Efficacy 安全性和有效性14.3 14.3BMS-986504 + Pembrolizumab: Bristol-Myers Squibb BMS-986504 + 帕博利珠单抗：百时美施贵宝14.4 14.4Iza-bren (izalontamab brengitecan): SystImmune and Bristol Myers Squibb 伊扎布伦（伊扎仑塔单抗布伦吉替康）：SystImmune 与百时美施贵宝14.5 14.5Neladalkib (NVL-655): Nuvalent 奈拉达克替尼（NVL-655）：Nuvalent公司14.6 14.6PF-08046054 (SGN-PDL1V): Pfizer PF-08046054（SGN-PDL1V）：辉瑞14.7 14.7Telisotuzumab adizutecan, Temab-A (ABBV-400): AbbVie Telisotuzumab adizutecan，Temab-A（ABBV-400）：艾伯维14.8 14.8Daraxonrasib (RMC-6236): Revolution Medicines 达拉松拉西布（RMC-6236）：Revolution Medicines公司14.9 14.9ZEJULA (niraparib): GlaxoSmithKline ZEJULA（尼拉帕利）：葛兰素史克14.10 14.10Rilvegostomig (AZD2936): AstraZeneca/Compugen Rilvegostomig（AZD2936）：阿斯利康/Compugen14.11 14.11Pumitamig (BNT327/PM8002): BioNTech/Bristol Myers Squibb 普米塔米格（BNT327/PM8002）：BioNTech/百时美施贵宝14.12 14.12CAN-2409 (aglatimagene besadenovec): Candel Therapeutics CAN-2409（阿格拉替马基因贝萨多诺韦克）：Candel Therapeutics14.13 14.13Gotistobart (BNT316): OncoC4/BioNTech 戈替斯托巴特（BNT316）：OncoC4/ BioNTech14.14 14.14ZYNYZ (retifanlimab-dlwr): Incyte/Macrogenics ZYNYZ（retifanlimab-dlwr）：Incyte/Macrogenics14.15 14.15LN-145: Iovance Biotherapeutics LN-145：Iovance Biotherapeutics14.16 14.16Divarasib (GDC-6036): Hoffmann-La Roche/Genentech Divarasib（GDC-6036）：霍夫曼-拉罗氏/基因泰克14.17 14.17Fianlimab (REGN3767): Regeneron Pharmaceuticals Fianlimab（REGN3767）：再生元制药公司14.18 14.18Sacituzumab Tirumotecan (MK-2870): Merck and Kelun-Biotech 萨西妥珠单抗替鲁替康（MK-2870）：默沙东与科伦博泰14.19 14.19Eftilagimod alpha (Efti, IMP321): Immutep 艾夫替拉莫德α（Efti，IMP321）：Immutep公司14.20 14.20Intismeran autogene (mRNA-4157/V940): Moderna Therapeutics and Merck Sharp & Dohme Intismeran autogene（mRNA-4157/V940）：莫德纳治疗公司与默沙东14.21 14.21Plinabulin: BeyondSpring 普利那布林：BeyondSpring14.22 14.22Zipalertinib (CLN-081): Cullinan Therapeutics and Taiho Pharma Zipalertinib (CLN-081)：Cullinan Therapeutics 与 Taiho Pharma14.24 14.24Olomorasib (LY3537982): Eli Lilly and Company 奥洛莫拉西布（LY3537982）：礼来公司14.25 14.25Ceralasertib (AZD6738): AstraZeneca Ceralasertib (AZD6738)：阿斯利康14.26 14.26TEDOPI (OSE2101): OSE Immunotherapeutics TEDOPI (OSE2101)：OSE免疫治疗公司14.27 14.27Sigvotatug Vedotin (PF08046047, SGN-B6A): Pfizer Sigvotatug Vedotin (PF08046047, SGN-B6A)：辉瑞14.28 14.28ANKTIVA (N-803, nogapendekin alfa inbakicept-pmln): ImmunityBio ANKTIVA（N-803，nogapendekin alfa inbakicept-pmln）：ImmunityBio14.29 14.29Pyrotinib: Jiangsu HengRui Medicine 吡咯替尼：江苏恒瑞医药14.30 14.30Volrustomig (MEDI5752): AstraZeneca Volrustomig（MEDI5752）：阿斯利康14.31 14.31TRODELVY (sacituzumab govitecan): Gilead Sciences 特罗达维（戈沙妥珠单抗）：吉利德科学14.32 14.32Domvanalimab + Combination Therapies: Arcus Biosciences and Gilead Sciences Domvanalimab联合疗法：Arcus Biosciences与Gilead Sciences14.33 14.33OPDUALAG (nivolumab and relatlimab): Bristol-Myers Squibb OPDUALAG（纳武利尤单抗和瑞拉利珠单抗）：百时美施贵宝14.34 14.34Calderasib (MK-1084): Merck, Otsuka Pharmaceutical (Taiho, and Astex Pharmaceuticals) Calderasib（MK-1084）：默克、大冢制药（Taiho 和 Astex Pharmaceuticals）14.35 14.35Firmonertinib: ArriVent BioPharma and Shanghai Allist Pharmaceuticals 法米替尼：ArriVent BioPharma 和上海艾力斯医药14.36 14.36Livmoniplimab (ARGX-115): AbbVie 利夫莫尼普利单抗（ARGX-115）：艾伯维14.37 14.37IBI363: Innovent Biologics and Takeda Pharmaceutical IBI363：信达生物与武田制药14.38 14.38Ivonescimab (AK112): Akeso Bio and Summit Therapeutics 依沃西单抗（AK112）：康方生物与 Summit Therapeutics14.39 14.39Vebreltinib (APL-101): Apollomics and Avistone Biotechnology 韦布替尼（APL-101）：阿波罗生物制药与艾维斯通生物技术14.4 14.4Zidesamtinib (NVL-520): Nuvalent Zidesamtinib（NVL-520）：Nuvalent15 十五Phase II Emerging Drugs Under Development 研发中的二期新兴药物16 16NSCLC: 7MM Market Analysis 非小细胞肺癌：7MM市场分析报告16.1 16.1Key Findings 主要发现16.2 16.2Total Market Size of NSCLC by Country in the 7MM 七个主要市场（7MM）中各国非小细胞肺癌（NSCLC）的总体市场规模16.3 16.3Total Market Size of NSCLC by Biomarker in the 7MM 七大主要市场中按生物标志物划分的非小细胞肺癌总市场规模16.4 16.4Market Outlook of NSCLC 非小细胞肺癌市场展望16.4.1 16.4.17MM Market Dynamics Overview of NSCLC 7MM NSCLC市场动态概览16.4.1.1 16.4.1.1PD-L1 Expression PD-L1表达16.4.1.2 16.4.1.2EGFR Mutation EGFR突变16.4.1.3 16.4.1.3ALK Mutation ALK突变16.4.1.4 16.4.1.4KRAS Mutation KRAS突变16.4.1.5 16.4.1.5BRAF Mutation BRAF突变16.4.1.6 16.4.1.6MET 气象16.4.1.7 16.4.1.7Others Emerging Biomarkers 其他新兴生物标志物16.5 16.5Key Market Forecast Assumptions 关键市场预测假设16.5.1 16.5.1PD-L1 Expression PD-L1表达16.5.2 16.5.2EGFR NSCLC EGFR非小细胞肺癌16.5.3 16.5.3ALK NSCLC ALK阳性非小细胞肺癌16.5.4 16.5.4KRAS NSCLC KRAS非小细胞肺癌16.5.5 16.5.5ROS-1 NSCLC ROS-1 非小细胞肺癌16.5.6 16.5.6HER2 NSCLC HER2 非小细胞肺癌16.5.7 16.5.7BRAF NSCLC BRAF 非小细胞肺癌16.5.8 16.5.8C-Met NSCLC C-Met非小细胞肺癌16.5.9 16.5.9RET NSCLC RET 非小细胞肺癌16.5.10 16.5.10NTRK NSCLC NTRK 非小细胞肺癌16.5.11 16.5.11NRG1 Fusion NSCLC NRG1融合非小细胞肺癌16.6 16.6The United States NSCLC Market 美国非小细胞肺癌市场16.7 16.7EU4 and the UK NSCLC Market 欧盟四国与英国非小细胞肺癌市场16.8 16.8Japan NSCLC Market 日本非小细胞肺癌市场17 17Unmet Needs of NSCLC 非小细胞肺癌的未满足需求18 18SWOT Analysis of NSCLC 非小细胞肺癌的SWOT分析19 十九KOL Views of NSCLC 非小细胞肺癌领域的关键意见领袖观点20 二十Market Access and Reimbursement of NSCLC 非小细胞肺癌的市场准入与报销21 二十一Bibliography 参考文献22 二十二NSCLC Market Report Methodology 非小细胞肺癌市场报告方法论Related Reports 相关报告Non-small Cell Lung Cancer 非小细胞肺癌Clinical Trial Analysis 临床试验分析Non-small Cell Lung Cancer 非小细胞肺癌Pipeline Insight 管道洞察– –2026 2026年report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including 报告提供了关于管线格局、管线药物概况（包括临床和非临床阶段产品）以及关键非小细胞肺癌公司的全面见解，包括ArriVent BioPharma, iTeos Therapeutics, GSK, Incyte, Macrogenics, AstraZeneca, Hutchison MediPharma, Hoffmann-La Roche, Genentech, AnaptysBio, Shanghai Henlius Biotech, Otsuka Pharmaceutical, Bristol-Myers Squibb, OSE Immunotherapeutics, Arcus Biosciences, Gilead Sciences, Pfizer, Cullinan Oncology, Taiho Pharma, ImmunityBio, Jiangsu Hansoh Pharmaceutical, Daiichi Sankyo, Boehringer Ingelheim, Moderna Therapeutics, Merck Sharp & Dohme, Eli Lilly and Company, BeyondSpring, Immutep, Genmab, Imugene, Dizal Pharmaceutical, Regeneron Pharmaceuticals, AbbVie, Candel Therapeutics, . ArriVent BioPharma、iTeos Therapeutics、葛兰素史克（GSK）、Incyte、MacroGenics、阿斯利康、和记黄埔医药、罗氏（Hoffmann-La Roche）、基因泰克（Genentech）、AnaptysBio、上海复宏汉霖生物技术、大冢制药、百时美施贵宝、OSE Immunotherapeutics、Arcus Biosciences、吉利德科学、辉瑞、Cullinan Oncology、Taiho Pharma、ImmunityBio、江苏恒瑞医药、第一三共、勃林格殷格翰、Moderna Therapeutics、默沙东（Merck Sharp & Dohme）、礼来公司、BeyondSpring、Immutep、Genmab、Imugene、迪哲医药、再生元制药、艾伯维（AbbVie）、Candel Therapeutics。and others. 以及其他。EGFR NSCLC Market EGFR非小细胞肺癌市场EGFR NSCLC Market Insights, Epidemiology, and Market Forecast – 2036 EGFR非小细胞肺癌市场洞察、流行病学及市场预测（至2036年）report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key EGFR NSCLC companies, including 报告提供了对疾病的深入理解、历史和预测的流行病学，以及市场趋势、市场驱动因素、市场障碍和关键的EGFR非小细胞肺癌公司，包括AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hansoh Pharmaceutical, Johnson & Johnson Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, Akeso Biopharma, Summit Therapeutics, 阿斯利康、勃林格殷格翰、礼来、翰森制药、强生创新药、辉瑞、Cullinan Oncology、大冢制药、ArriVent Biopharma、Black Diamond Therapeutics、第一三共、康方生物、Summit Therapeutics，and others. 以及其他。EGFR Inhibitors Market EGFR抑制剂市场EGFR Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 EGFR抑制剂市场规模、目标人群、竞争格局及市场预测——2036年report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key EGFR inhibitors companies, including 报告深入解析了市场趋势、市场驱动因素、市场壁垒以及关键的EGFR抑制剂企业，包括Cullinan Oncology, Taiho Pharma, ArriVent BioPharma, Akeso Biopharma, Summit Therapeutics, Pfizer, Daiichi Sankyo, AstraZeneca, Merck, Kelun-Biotech, CSPC Pharmaceutical, Shanghai JMT-Bio, Bristol-Myers Squibb, AbbVie, Lantern Pharma, Wayshine Biopharm, Teligene US, Genprex, J Ints Bio, Black Diamond Therapeutics, BlossomHill Therapeutics, Scorpion Therapeutics, Pierre Fabre, Antares Therapeutics, A2 Biotherapeutics, BioNTech, Dragonfly Therapeutics, Merus, DualityBio, ORIC Pharmaceuticals, BeOne Medicines (formerly BeiGene), Dizal Pharmaceutical, Jiangsu Hansoh Pharmaceutical, Boehringer Ingelheim, Pfizer, Johnson & Johnson Innovative Medicine, Yuhan Corporation, Eli Lilly and Company,. Cullinan Oncology、Taiho Pharma（大正制药）、ArriVent BioPharma（阿瑞云生物）、Akeso Biopharma（康方生物）、Summit Therapeutics、Pfizer（辉瑞）、Daiichi Sankyo（第一三共）、AstraZeneca（阿斯利康）、Merck（默克）、Kelun-Biotech（科伦博泰）、CSPC Pharmaceutical（石药集团）、Shanghai JMT-Bio（上海君实生物）、Bristol-Myers Squibb（百时美施贵宝）、AbbVie（艾伯维）、Lantern Pharma、Wayshine Biopharm（微芯生物）、Teligene US、Genprex、J Ints Bio、Black Diamond Therapeutics、BlossomHill Therapeutics、Scorpion Therapeutics、Pierre Fabre（皮尔法伯）、Antares Therapeutics、A2 Biotherapeutics、BioNTech（拜恩泰科）、Dragonfly Therapeutics、Merus、DualityBio（康诺亚）、ORIC Pharmaceuticals、BeOne Medicines（前身为百济神州）、Dizal Pharmaceutical（迪哲医药）、Jiangsu Hansoh Pharmaceutical（江苏恒瑞医药）、Boehringer Ingelheim（勃林格殷格翰）、Pfizer（辉瑞）、Johnson & Johnson Innovative Medicine（强生创新制药）、Yuhan Corporation（柳韩洋行）、Eli Lilly and Company（礼来公司）。and others. 以及其他。Antibody Drug Conjugates Market 抗体药物偶联物市场Antibody Drug Conjugates Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 抗体药物偶联物市场规模、目标人群、竞争格局及市场预测——2036年report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key ADCs companies, including 报告深入分析了市场趋势、市场驱动因素、市场壁垒以及关键的ADC公司，包括ImmunoGen, Daiichi Sankyo, AstraZeneca, Seagen, Sorrento Therapeutics, Inc., Mythic Therapeutics, Merck KGaA, NBE-Therapeutics AG, Gilead Sciences, Regeneron Pharmaceuticals, Kirilys Therapeutics Inc., Tanabe Research Laboratories USA Inc, Sutro Biopharma, Inc., OBI Pharma, Inc, MediLink Therapeutics (Suzhou) Co., Ltd., TORL Biotherapeutics, LLC, Ambrx, Inc.,. ImmunoGen、第一三共、阿斯利康、Seagen、Sorrento Therapeutics, Inc.、Mythic Therapeutics、默克（KGaA）、NBE-Therapeutics AG、吉利德科学、再生元制药、Kirilys Therapeutics Inc.、田边美国研究实验室有限公司、Sutro Biopharma, Inc.、OBI Pharma, Inc.、迈迪安龙药业（苏州）有限公司、TORL Biotherapeutics, LLC、Ambrx, Inc.。and others. 以及其他。About 关于DelveInsight DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platformPharmDelve. DelveInsight 是一家领先的商业咨询和市场研究公司，专注于生命科学领域。它通过提供全面的端到端解决方案来帮助制药公司提升绩效。通过我们基于订阅的平台 PharmDelve，您可以轻松获取所有医疗保健和制药市场研究报告。. 。Contact Us 联系我们Shruti Thakur 什鲁蒂·塔库尔[emailprotected] [email protected]+14699457679 +14699457679www.delveinsight.com www.delveinsight.comLogo: 标志：https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpgSOURCE DelveInsight Business Research, LLP 来源：DelveInsight Business Research, LLP21 二十一% %more press release views with 更多新闻稿浏览量Request a Demo 申请演示

2026-07-01

·CPHI制药在线

黑色素瘤——罕见病思路开发肿瘤药物

关注并星标CPHI制药在线肿瘤始终是所有疾病中致死率最高的疾病，非小细胞肺癌、肝癌、胃癌、乳腺癌等疾病是众多药企重点攻关的领域。然而，在热门的肿瘤领域，黑色素瘤却是一个“冷门”的存在。整体患者基数没有肺癌、乳腺癌那样庞大，却在过去数年间催生了PD-1抑制剂、BRAF靶向药、LAG-3抗体等一系列划时代的免疫和靶向疗法。如今，这个领域正在上演一场新的变革：用罕见病的开发思路，去攻克一个“并不罕见”的肿瘤。一、全球 vs 中国 1.1 全球黑色素瘤：地域差异性极大黑色素瘤在全球范围内是一个典型的“地域病”。全球每年新发约33.17万例，其中男性约18.0万，女性约15.2万。全球年龄标化发病率约为3.2/10万，死亡率0.53/10万。但这一平均值掩盖了极大的地域差异。大洋洲（澳大利亚/新西兰）发病率最高，可达每10万人50-60例，部分地区如昆士兰甚至超过70例。北美和欧洲也处于高位，美国年发病率约28.2/10万（男）和16.8/10万（女），2025年美国新发侵袭性黑色素瘤预计约10.96万例。北欧国家如丹麦、挪威发病率同样居高不下。而在亚洲，黑色素瘤却是一个真正的“罕见病”。亚洲男女发病率分别仅约0.5/10万和0.4/10万。中国2021年GBD数据显示年龄标化发病率为0.7/10万，虽较1990年增长了89.2%，绝对值仍然极低。这种差异的核心决定因素是人种肤色。Fitzpatrick皮肤光反应类型I-II型的浅肤色人群，紫外线暴露后黑色素瘤风险急剧升高；而亚洲、非洲等深肤色人群，黑色素瘤发病率低2个数量级。美国1999-2006年近29万例晚期黑色素瘤患者中，白人占95%，黑人仅0.5%，亚裔及太平洋岛民仅0.3%。新西兰1996-2006年1.6万例新发中，欧洲裔占99%，毛利族1%，太平洋岛民0.2%，亚裔仅0.1%。 1.2 中国黑色素瘤：被忽视的“亚型鸿沟” 中国黑色素瘤年新发病例约8,000至19,000例，存量患者约10万人。从绝对数字看，它确实属于“小瘤种”。但真正的差异不在于数量，而在于亚型分布。欧美黑色素瘤以皮肤型（慢性日光损伤型）为主，占比约90%，多发生在躯干和四肢，与紫外线暴露密切相关。这类肿瘤突变负荷高，对PD-1抑制剂单药有效率可达40%左右，联合CTLA-4或LAG-3后可进一步提升至50%以上。而中国黑色素瘤的亚型分布截然不同。根据全国肿瘤登记中心及多家大型中心医院数据，肢端型（手掌、脚底、甲下）占比约51%（部分研究报道38%-52%），黏膜型（鼻腔、口腔、直肠肛管等）占比约17%，两类合计超过三分之二。慢性日光损伤型（即皮肤型）仅占7%。这与美国形成鲜明对比：非西班牙裔白人仅1%为黏膜型，而亚裔/太平洋岛民中黏膜型占15%，非西班牙裔黑人占9%，西班牙裔占4%。这一亚型差异直接决定了治疗的“冰火两重天”。肢端型和黏膜型黑色素瘤具有独特的基因组特征——BRAF突变率低（仅约10%-15% vs 皮肤型40%-50%），c-KIT突变相对多见，肿瘤微环境中T细胞浸润少，呈现“冷肿瘤”表型。因此，肢端和黏膜型黑色素瘤对PD-1单药的有效率仅10%-20%，中位无进展生存期仅2.3个月，远低于欧美患者的40%。这意味着，在中国，占绝大多数的黑色素瘤患者，用全球最主流的免疫疗法，效果大打折扣。而一旦PD-1治疗失败，二线化疗有效率仅7%-8%，PFS仅为2.2个月。这就是中国黑色素瘤市场最核心的未满足临床需求——一个被全球主流药物“遗漏”的巨大盲区。 1.3 市场规模的冰与火从市场规模看，差距同样悬殊。2025年全球黑色素瘤药物市场估值约83亿美元，预计2034年达237亿美元，年复合增长率12.3%。BRAF/MEK联合抑制疗法2025年约42.5亿美元，LAG-3抑制剂Opdualag单药2025年销售额已达11.85亿美元。而中国黑色素瘤市场规模2024年仅约61.81亿元人民币（约8.7亿美元），全球占比不足10%。但随着国产PD-1抑制剂特瑞普利单抗2025年获批晚期黑色素瘤一线治疗并纳入国家医保，以及康奈非尼（BRAF抑制剂）2025年在国内获批上市，多款TIL疗法进入关键II期临床，中国黑色素瘤创新药市场正进入加速放量阶段。然而，受限于绝对发病率低、亚型特殊导致现有高价药物疗效有限，这个市场注定不会像肺癌那样成为“重磅炸弹”的温床——它更适合罕见病思路下的精准开发和利基市场策略。要通过高单价、小人群、差异化机制来实现商业回报。这正是罕见病药物的典型逻辑。二、创新药的开发思路：从“广谱”到“亚型聚焦” 过去十年，黑色素瘤的治疗格局已被彻底改写。BRAF/MEK靶向药（达拉非尼+曲美替尼2025年约22亿美元，恩考芬尼+比美替尼约7.5-8亿美元）、PD-1抑制剂（帕博利珠单抗、纳武利尤单抗）、CTLA-4抑制剂（伊匹木单抗），以及首个LAG-3联合方案Opdualag（2022年获批，2025年销售额达11.85亿美元），构成了强大的治疗矩阵。但这些方案主要惠及的是皮肤型患者，且大部分由跨国药企主导。面对中国特殊的肢端/黏膜型黑色素瘤，以及全球范围内PD-1耐药后的巨大空白，新一代创新药的开发正在走一条“小而精”的路。以下三个方向尤其值得关注。 2.1 TIL细胞疗法：实体瘤细胞治疗的“中国速度” TIL疗法是2024年最受瞩目的实体瘤细胞治疗突破。2024年2月，Iovance Biotherapeutics的lifileucel（Amtagvi）获FDA加速批准，用于既往接受过PD-1抑制剂治疗的晚期黑色素瘤，成为全球首款实体瘤T细胞疗法。其定价一次性51.5万美元，上市首年销售额1.036亿美元，2025年增长至2.2亿美元，同比增速超110%。注册临床试验客观缓解率29%，但真实世界后线治疗（41例患者，医生评估）达到48.8%，其中三线或更早治疗患者缓解率高达60.9%，显示出在更前线应用的巨大潜力。 Amtagvi联合帕博利珠单抗一线治疗黑色素瘤的III期TILVANCE-301试验已获FDA快速通道资格，若成功，TIL疗法将从末线跃升至一线，目标人群从每年约2-3万后线患者扩展至全球30多万新发患者。中国在这一赛道已形成全球第二梯队。截至2025年底，三款TIL产品进入黑色素瘤治疗关键II期临床：华赛伯曼HS-IT101（I期ORR 50%，完全缓解率20%）、蓝马医疗LM103（I期推荐剂量组ORR 50%，DCR 100%）、君赛生物GC101。中国TIL产品的差异化优势在于：①定价有望显著低于美国（51.5万美元/次），预计在20-30万人民币区间；②针对肢端/黏膜型黑色素瘤这一对PD-1低响应的人群，TIL的多靶点识别能力具有天然优势；③企业自建产能和自动化生产流程缩短制备周期（华赛伯曼FAST-TIL将周期压缩至14天，优于传统22-28天），降低成本并提高可及性。 2.2 mRNA个性化肿瘤疫苗：免疫治疗的“主动教育” mRNA-4157（V940，Moderna/默沙东）是全球首个进入III期的mRNA个性化癌症疫苗。在黑色素瘤辅助治疗中联合Keytruda，KEYNOTE-942 IIb期研究的5年随访数据显示，联合组复发或死亡风险较Keytruda单药降低49%（HR=0.510），远侧无转移生存期HR达0.384。疗效从2年随访时的44%提升至3年及5年的49%，且稳定维持——这是mRNA肿瘤疫苗能够诱导持久免疫记忆的首次人体长期证据。该疫苗已获FDA突破性疗法认定，预计2027年上市。然而，mRNA个性化疫苗的发展并非一帆风顺。2025年10月，BioNTech宣布终止其BNT111在特定晚期难治性黑色素瘤中的进一步开发。BNT111为固定组合肿瘤相关抗原疫苗，II期数据显示联合PD-1的ORR仅18.1%，中位PFS 3.1个月，未能达到内部疗效阈值。这一分化清晰表明：个性化新抗原疫苗（mRNA-4157）在辅助治疗场景中的价值远大于固定抗原疫苗在晚期难治场景中的价值。中国已有超过30家企业布局mRNA肿瘤疫苗，这些管线的共同挑战是：个体化生产周期约30-40天、成本高昂，以及中国黑色素瘤肢端/黏膜型高占比对“通用新抗原”库的适配性问题。但若能通过AI算法优化和规模化生产降低成本，mRNA疫苗有望成为黑色素瘤术后辅助治疗的新标准。 2.3 新免疫检查点：LAG-3的成功与TIGIT/TIM-3的警示 LAG-3已经成功商业化，Opdualag 2025年销售额11.85亿美元，在美国转移性黑色素瘤一线市场占据约30%份额。但后续TIGIT、TIM-3等靶点的III期试验却频频受挫。默沙东的vibostolimab在切除术后黑色素瘤辅助治疗中，联合帕博利珠单抗不仅未能延长无复发生存期，反而以HR 1.25（复发风险增加25%）和显著增加的免疫相关毒性宣告失败；2026年5月，Regeneron的fianlimab联合cemiplimab在一线转移性黑色素瘤III期试验中未达到统计学显著（PFS HR=0.845，p=0.0627），尽管高剂量组中位PFS达11.5个月 vs 帕博利珠单抗单药6.4个月，但试验设计因同时测试两种剂量承担了过大的统计负担。这些教训表明：在PD-1已将客观缓解率提升至40%-50%的背景下，新靶点必须找到更精准的患者亚群，而非简单做“PD-1+X”的加法。新辅助治疗正成为关键验证窗口——2025年ASCO上，TIGIT联合PD-L1新辅助治疗高危III期黑色素瘤取得47.1%的主要病理缓解率，TIM-3联合PD-1更是达到55.6%，且安全性良好。这些数据为后续注册性试验指明了方向，但也提醒我们：辅助治疗与转移性一线治疗的疗效存在本质差异，同一靶点在不同治疗线数中的价值可能天差地别。三、未来商业化的逻辑：洞察市场，精准打击中国黑色素瘤每年新发仅1-2万例，存量患者约10万人，属于典型的“小瘤种”。但正是因为小，才需要用罕见病的逻辑来开发、注册和商业化。国家药监局（NMPA）对罕见病药物有优先审评、附条件批准、突破性治疗认定等绿色通道。黑色素瘤在中国虽未被正式列入第一批罕见病目录（患者数略高于罕见病标准，罕见病定义通常为<5万/年），但完全可以参照罕见病思路申报，争取纳入临床急需境外新药名单或获得突破性疗法认定。2025年国产PD-1特瑞普利单抗一线黑色素瘤适应症的快速获批即为先例。中国黑色素瘤市场的人均年治疗费用（医保后约8000-20000美元）仅为美国的1/10到1/15。这并非单纯因为医保控价，更深层的原因在于：肢端/黏膜型对现有免疫疗法响应不佳，导致高价药物无法带来与之匹配的临床获益，医生和患者的使用意愿自然低下。创新药要在中国放量，必须兼顾疗效与成本。 TIL疗法在美国定价51.5万美元/次，中国产品若能将生产成本压缩至15-20万人民币/次（通过自动化生产、缩短培养周期、减少IL-2使用等），再通过医保谈判将患者自付比例降至可接受范围（如年自付<15万人民币），就有望打开每年数千例患者的市场。而小分子靶向药若能实现口服、低毒性，年治疗费用控制在10-15万人民币，甚至可作为长期维持治疗，形成稳定现金流。中国黑色素瘤市场的支付结构可分为三个层次：①医保覆盖层（特瑞普利单抗、达拉非尼+曲美替尼等），年费用5-15万人民币，覆盖约40%-60%患者；②自费/商保层（TIL、创新联合方案），年费用20-50万人民币，覆盖约10%-20%高端患者；③基础治疗层（化疗、对症支持），年费用1-5万人民币，覆盖30%-40%经济受限群体。创新药应根据自身机制和数据，选择适合的支付层级——高端自费适合TIL这类“一次性治愈”疗法；医保放量适合小分子口服药这类“慢病管理”产品。黑色素瘤正在从“皮肤癌中的少数派”变成肿瘤免疫治疗的“风向标”。在中国，它更是一个独特的“罕见病化”市场：患者基数小、亚型特殊、对现有疗法响应差，但政策支持、技术突破、成本优势交织，正在催生一批具有全球竞争力的创新疗法。未来的赢家，不是那些盲目追求“广谱抗癌”的“大分子”，而是愿意沉下心来做肢端、做黏膜、做耐药的“窄谱专家” 。用罕见病的思路，做出不罕见的疗效——这或许是中国黑色素瘤药物开发最好的注脚，也是中国创新药在全球肿瘤免疫版图中找到自己位置的一条可行之路。 END 扫码领取2026年CPHI深圳展门票来源：研界OmniSci 声明：本网站内容仅出于传递更多信息之目的。并不代表制药在线立场。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

100 项与 Fianlimab 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
晚期非小细胞肺癌	临床3期	美国	Regeneron Pharmaceuticals, Inc.	2023-06-30
晚期非小细胞肺癌	临床3期	澳大利亚	Regeneron Pharmaceuticals, Inc.	2023-06-30
晚期非小细胞肺癌	临床3期	加拿大	Regeneron Pharmaceuticals, Inc.	2023-06-30
晚期非小细胞肺癌	临床3期	以色列	Regeneron Pharmaceuticals, Inc.	2023-06-30
晚期非小细胞肺癌	临床3期	马来西亚	Regeneron Pharmaceuticals, Inc.	2023-06-30
晚期非小细胞肺癌	临床3期	韩国	Regeneron Pharmaceuticals, Inc.	2023-06-30
晚期非小细胞肺癌	临床3期	西班牙	Regeneron Pharmaceuticals, Inc.	2023-06-30
晚期非小细胞肺癌	临床3期	中国台湾	Regeneron Pharmaceuticals, Inc.	2023-06-30
晚期非小细胞肺癌	临床3期	泰国	Regeneron Pharmaceuticals, Inc.	2023-06-30
晚期非小细胞肺癌	临床3期	土耳其	Regeneron Pharmaceuticals, Inc.	2023-06-30

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03005782 (Fianlimab + cemiplimab, AACR2025)	临床1期	晚期癌症新辅助 \| 辅助 LDH \| BRAF \| adrenal insufficiency ... 更多	98	Fianlimab 1600 mg + Cemiplimab 350 mg	糧築鬱壓淵衊鏇壓鬱壓(範糧齋襯窪選鬱鹹醖獵) = Grade ≥3 TEAEs occurred in 47% of pts 餘築衊糧憲網網願遞顧 (範遞範積憲構繭製鏇簾 ) 更多	积极	2025-04-29
ASTRO2024	N/A	头颈癌转移	-	Cemiplimab monotherapy	醖製齋廠構鹹願鹽夢齋(憲夢積鬱網廠糧蓋鏇糧) = 47% vs 13% of pts 壓齋築鬱鑰築鹹願獵網 (網襯淵糧鏇夢鹽窪願襯 ) 更多	-	2024-10-01
				Fianlimab + Cemiplimab combination
NCT03005782 (ESMO2024) 人工标引	临床1期	黑色素瘤 LAG3 Positive \| PD-L1	98	fianlimab mg + CEMI cemiplimab	繭壓壓獵願壓糧範願積(鑰壓蓋蓋選膚餘廠夢鹽) = 醖膚範鹹醖衊齋壓壓遞夢遞鏇廠鹽選糧遞觸糧 (積觸憲顧鹹淵簾蓋獵鹹 ) 更多	积极	2024-09-14
NCT03005782 (Pubmed) 人工标引	临床1期	黑色素瘤辅助	-	Fianlimab 1,600 mg + Cemiplimab 350 mg	鏇廠廠蓋獵構遞壓窪築(構餘鹹簾網廠衊積顧糧) = 夢齋廠獵蓋願鏇觸獵顧簾網製積窪繭鹹壓築夢 (築簾鹹襯鏇構鬱鹹夢鹹 ) 更多	积极	2024-06-20
				Fianlimab 1,600 mgFianlimab 1,600 mg + Cemiplimab 350 mgCemiplimab 350 mg (systemic treatment-naïve melanoma)	鏇廠廠蓋獵構遞壓窪築(構餘鹹簾網廠衊積顧糧) = 壓鬱夢鹹鑰夢夢膚衊夢簾網製積窪繭鹹壓築夢 (築簾鹹襯鏇構鬱鹹夢鹹 )
NCT03005782 (Phase 1 study of fianlimab (anti-LAG-3) in combination with cemiplimab (anti-PD-1) in patients with advanced HNSCC, ASCO2024)	临床1期	头颈部鳞状细胞癌	30	Fianlimab 1600 mg + Cemiplimab 350 mg	願鏇築製簾襯蓋壓糧艱(餘鏇衊獵鏇餘衊糧築遞) = In cohort 12, there was one death due to grade 5 respiratory failure attributable to aspiration pneumonia 窪觸獵鹽築簾築窪夢襯 (觸構觸繭憲鹽鏇願築積 )	积极	2024-05-24
NCT03005782 (ASCO_GU2024) 人工标引	临床1期	肾细胞癌	30	fianlimab 1600 mg + cemiplimab 350 mg (anti–PD-1/PD-L1-naïve)	遞艱積鬱廠襯鹹醖遞鬱(鏇齋鑰觸顧網憲鑰鹹顧) = 鑰壓製蓋夢構網獵鏇積鏇膚網餘鏇襯鏇積夢餘 (壓艱顧蓋網範觸窪選廠 ) 更多	积极	2024-01-25
				fianlimab1600 mg + cemiplimab 350 mg (anti–PD-1/L1-experienced)	憲範獵鬱製衊醖簾蓋鹹(鹹衊膚鹽選齋淵淵襯簾) = 衊繭觸窪餘憲繭顧衊衊襯網夢齋廠顧遞獵醖選 (蓋網壓齋鑰築築願網憲 ) 更多
NCT03005782 (FIH POC study1, NEWS) 人工标引	临床1期	转移性黑色素瘤	98	fianlimab+cemiplimab (Cohort MM1(Initial))	窪構築鹹蓋膚獵膚衊廠(窪壓範獵憲願蓋蓋壓積) = 齋壓鏇繭製衊醖鹹鹹獵構網遞蓋獵襯壓願糧膚 (製壓網廠觸夢願鏇觸艱 ) 更多	优效	2024-01-08
				fianlimab+cemiplimab (Cohort MM2(Confirmatory))	窪構築鹹蓋膚獵膚衊廠(窪壓範獵憲願蓋蓋壓積) = 積鏇糧鏇簾範鬱獵簾鹹構網遞蓋獵襯壓願糧膚 (製壓網廠觸夢願鏇觸艱 ) 更多
NCT03005782 (ASCO2023) 人工标引	临床1期	局部晚期黑色素瘤	98	Fianlimab 1600 mg + Cemiplimab 350 mg	餘淵遞網範鑰壓醖膚廠(糧蓋鏇積蓋繭餘襯積簾) = 簾簾繭艱簾衊餘顧艱窪夢蓋廠艱鏇願鑰繭選餘 (鹹願鑰糧夢壓選憲鑰糧 ) 更多	积极	2023-05-31
				Fianlimab 1600 mg + Cemiplimab 350 mg (with prior iCPIs )	糧鑰壓衊襯遞鹽鬱觸壓(範淵壓網製顧觸鹹鑰遞) = 繭膚顧窪襯構網顧蓋鬱壓觸範衊積廠遞醖鏇鬱 (鏇製遞淵醖襯鑰衊選鹹 )
NCT03005782 (ASCO 12023 \| ASCO 22023) 人工标引	临床1期	局部晚期黑色素瘤	98	Cemiplimab-RWLC+Fianlimab	遞夢糧餘願鑰觸衊襯淵(構衊構鑰選築醖夢蓋製) = 32.7% 衊衊鬱膚網網齋製襯廠 (艱醖願簾鹹觸膚構範淵 ) 更多	积极	2023-05-26
				Cemiplimab-RWLC+Fianlimab (pts with any prior adj Tx)
NCT03005782 (AAD2023)	临床1期	局部晚期黑色素瘤	-	fianlimab 1600 mg + cemiplimab 350 mg	鏇範顧膚壓廠鏇夢願範(範夢夢選鑰遞餘範積淵) = 範鏇製觸憲願鹽願鏇範遞繭壓築鬱築鹽鑰淵獵 (壓範夢構顧壓觸獵繭夢 ) 更多	-	2023-03-17