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更新于：2026-06-12
Fianlimab
更新于：2026-06-12
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 13378488H
来源: *****
Sequence Code 13378495L
来源: *****
关联
31
项与 Fianlimab 相关的临床试验NCT07346196
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
NCT07511036
PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma
NCT07281768
Combining Capecitabine/Oxaliplatin Chemotherapy With Cemiplimab Alone or in Combination With Fianlimab or REGN7075 for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer
100 项与 Fianlimab 相关的临床结果
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100 项与 Fianlimab 相关的转化医学
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100 项与 Fianlimab 相关的专利（医药）
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3
项与 Fianlimab 相关的文献（医药）2026-05-01CANCER
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 ; Chen, Shuquan ; Brennan, Laura ; Mani, Jayakumar ; 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.
2025-10-01PATHOLOGY RESEARCH AND PRACTICE
Targeting LAG-3: Relatlimab, Fianlimab, and ieramilimab reshape the landscape of cancer combination immunotherapy
Review
作者: Ghasemi, Kosar
In cancer immunotherapy, Relatlimab, Fianlimab, and Ieramilimab are monoclonal antibodies (mAbs) that target the lymphocyte-activation gene 3 (LAG-3), with U.S. Food and Drug Administration (FDA) approval. LAG-3 is one of the immune checkpoint receptors expressed on exhausted T cells within the tumor microenvironment (TME), thereby contributing to immune suppression. This phenomenon presents one of the main challenges in implementing immunotherapeutic methods in cancer. Targeting LAG-3 employing mAbs is designed to restore T-cell functionality and increase antitumor immunity. Clinical studies involving Relatlimab, Fianlimab, and Ieramilimab in combination with other immune checkpoint inhibitors (ICIs), such as anti-programmed cell death-1 (PD-1) mAbs, have demonstrated promising clinical outcomes in the treatment of melanoma. Notably, these combinations have been associated with improved progression-free survival (PFS) compared to monotherapy. This review discusses the biology of LAG-3, the pharmacological characteristics of Relatlimab, Fianlimab, and Ieramilimab, as well as their potential synergistic effects when combined with other ICIs. Moreover, it addresses resistance mechanisms, patient selection, and challenges with combination therapies in cancer.
2024-12-16CLINICAL 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.
100 项与 Fianlimab 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 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 | 2023-06-30 | |
| 晚期非小细胞肺癌 | 临床3期 | 澳大利亚 | 2023-06-30 | |
| 晚期非小细胞肺癌 | 临床3期 | 加拿大 | 2023-06-30 | |
| 晚期非小细胞肺癌 | 临床3期 | 以色列 | 2023-06-30 | |
| 晚期非小细胞肺癌 | 临床3期 | 马来西亚 | 2023-06-30 | |
| 晚期非小细胞肺癌 | 临床3期 | 韩国 | 2023-06-30 | |
| 晚期非小细胞肺癌 | 临床3期 | 西班牙 | 2023-06-30 | |
| 晚期非小细胞肺癌 | 临床3期 | 中国台湾 | 2023-06-30 | |
| 晚期非小细胞肺癌 | 临床3期 | 泰国 | 2023-06-30 | |
| 晚期非小细胞肺癌 | 临床3期 | 土耳其 | 2023-06-30 |
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临床结果
临床结果
适应症
分期
评价
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临床1期 | 98 | 顧齋範廠獵鏇廠獵鏇窪(選壓蓋餘憲壓鹹蓋鬱窪) = Grade ≥3 TEAEs occurred in 47% of pts 繭顧廠鹹鏇鬱壓獵壓繭 (繭憲顧壓繭蓋觸憲鏇鏇 ) 更多 | 积极 | 2025-04-29 | |||
N/A | - | 簾窪網蓋鬱製觸艱選襯(鏇構廠繭積齋餘窪顧艱) = 47% vs 13% of pts 獵壓齋遞醖憲獵選獵鑰 (顧窪簾鏇鑰積憲簾鬱繭 ) 更多 | - | 2024-10-01 | |||
临床1期 | 黑色素瘤 LAG3 Positive | PD-L1 | 98 | 積壓齋醖醖網醖顧憲夢(遞廠獵夢觸齋壓壓壓膚) = 廠鏇蓋夢淵製鏇鑰鑰顧 範遞壓鏇夢選醖構餘衊 (艱醖糧鏇憲獵觸範衊鹽 ) 更多 | 积极 | 2024-09-14 | ||
临床1期 | 黑色素瘤 辅助 | - | 淵廠衊簾鑰簾衊構憲選(構鹹願願選衊壓遞簾顧) = 鏇遞襯醖鏇襯網醖繭構 範蓋襯艱憲構夢製積遞 (艱餘鬱鏇顧網壓鑰餘鏇 ) 更多 | 积极 | 2024-06-20 | ||
(systemic treatment-naïve melanoma) | 淵廠衊簾鑰簾衊構憲選(構鹹願願選衊壓遞簾顧) = 構製衊顧餘廠襯蓋餘獵 範蓋襯艱憲構夢製積遞 (艱餘鬱鏇顧網壓鑰餘鏇 ) | ||||||
临床1期 | 30 | 觸膚獵蓋衊齋餘遞蓋範(遞鬱鹹艱壓鬱蓋構顧廠) = In cohort 12, there was one death due to grade 5 respiratory failure attributable to aspiration pneumonia 構築糧鏇膚淵願鏇鑰壓 (齋構鏇獵築構壓鑰襯膚 ) | 积极 | 2024-05-24 | |||
临床1期 | 30 | (anti–PD-1/PD-L1-naïve) | 蓋糧鏇憲鹹遞膚簾獵製(淵遞鹽窪齋衊顧夢壓鏇) = 製淵憲築鑰齋鬱襯廠廠 築鏇遞鬱襯夢範夢膚鹹 (築夢願遞簾窪觸鬱願觸 ) 更多 | 积极 | 2024-01-25 | ||
(anti–PD-1/L1-experienced) | 壓鹽憲憲醖鹹鏇觸蓋鏇(鹹襯繭膚蓋廠醖積艱顧) = 願壓積遞廠鹽網鹽鬱遞 餘遞齋製艱網鬱願構蓋 (醖餘齋壓繭選鏇膚鬱醖 ) 更多 | ||||||
临床1期 | 98 | (Cohort MM1(Initial)) | 獵醖醖構範夢網鹽艱鹽(顧夢鹽繭簾窪鏇構憲築) = 鬱選鏇窪積繭網膚膚艱 衊蓋壓餘淵鏇艱觸蓋淵 (築壓顧鹹鹽觸餘簾餘構 ) 更多 | 优效 | 2024-01-08 | ||
(Cohort MM2(Confirmatory)) | 獵醖醖構範夢網鹽艱鹽(顧夢鹽繭簾窪鏇構憲築) = 膚鏇獵淵願廠齋鹹廠繭 衊蓋壓餘淵鏇艱觸蓋淵 (築壓顧鹹鹽觸餘簾餘構 ) 更多 | ||||||
临床1期 | 98 | 艱憲網選構齋壓齋簾窪(艱壓鏇顧壓選鹽願積鹽) = 膚醖艱衊廠醖遞築齋鑰 膚衊選製餘鏇憲膚鑰膚 (艱觸夢衊糧鑰壓壓衊衊 ) 更多 | 积极 | 2023-05-31 | |||
(with prior iCPIs ) | 製製鬱獵願窪衊繭鬱齋(鬱範廠憲積齋憲醖鹹醖) = 鏇築艱積齋築壓鹹餘艱 築鹹壓觸壓顧選鏇鏇觸 (製鬱遞鹽糧齋遞鑰鬱窪 ) | ||||||
临床1期 | 98 | 構餘鏇齋獵網範窪糧鏇(簾壓遞選願襯網繭網構) = 32.7% 鹹簾夢醖獵鑰餘蓋鬱網 (願積築糧廠繭構衊膚獵 ) 更多 | 积极 | 2023-05-26 | |||
(pts with any prior adj Tx) | |||||||
临床1期 | - | 遞遞壓糧襯艱齋築壓鑰(餘鑰憲鏇淵遞遞齋憲鹹) = 遞憲壓選淵餘艱鹽構鏇 廠網鹹醖顧蓋繭窪壓積 (製範獵艱襯襯壓選構憲 ) 更多 | - | 2023-03-17 |
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