Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy)

开始日期2046-12-31

申办/合作机构-

NCT06592664

/ Withdrawn临床1/2期

A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

开始日期2030-01-01

申办/合作机构

Lisata Therapeutics, Inc.

NCT07639528

/ Not yet recruiting临床2期IIT

Phase II, Open Label, Non-Randomized, Study of Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC)

This phase II trial tests the safety and effectiveness of preoperative immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine with or without futibatinib targeted therapy in treating patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine and/or targeted therapy with futibatinib before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. Patients whose molecular profiling test result show a genetic change called FGFR2 fusion, rearrangement, or activating mutation, receive immunotherapy, chemotherapy and targeted therapy while patients without a FGFR2 fusion, rearrangement, or activating mutation just receive immunotherapy and chemotherapy. Giving targeted therapy based on molecular profile test results prior to attempted resection for patients with intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes in patients with resectable intrahepatic cholangiocarcinoma.

开始日期2027-12-10

申办/合作机构

Northwestern University

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100 项与盐酸吉西他滨相关的临床结果

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100 项与盐酸吉西他滨相关的转化医学

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100 项与盐酸吉西他滨相关的专利（医药）

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15,227

项与盐酸吉西他滨相关的文献（医药）

2026-12-31·JOURNAL OF MEDICAL ECONOMICS

Budget impact model of nadofaragene firadenovec for the treatment of high-risk non-muscle-invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin immunotherapy

Article

作者: Ye, Dongni ; Yang, Min ; Chai, Xinglei ; Moradi, Ashton ; Lotan, Yair ; Zhao, Angela

AIMS:

To estimate the budget impact of adopting nadofaragene firadenovec for the treatment of adults with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors (CIS ± Ta/T1) from a US third-party payer's perspective.

METHODS:

A budget impact model was developed to compare total healthcare costs under two scenarios: (1) with nadofaragene firadenovec included in the treatment mix, and (2) without it. The model simulated a hypothetical US health plan covering one million members over a 3-year time horizon. Costs assessed included drug acquisition and administration, surveillance and disease management, cystectomy, and treatment-related adverse events (AEs). Base-case inputs were informed by trial data, published literature, and real-world evidence. Scenario analyses explored alternative population definitions, epidemiology and clinical inputs; one-way sensitivity analyses tested parameter uncertainty.

RESULTS:

In the base-case, the estimated per-member-per-month (PMPM) budget impact of adopting nadofaragene firadenovec ranged from $0.0010 in Year 1 to $0.0084 in Year 3. Increased drug and administration costs were partially offset by cost savings from reduced disease progression, fewer cystectomies, and lower AE rates. Scenario analyses demonstrated that even examining a broader population including papillary disease-only patients, the budget impact remained modest ($0.0064-$0.0548 PMPM from Years 1-3). Sensitivity analyses confirmed that results were most influenced by uptake rate, drug cost, and target population size.

LIMITATIONS:

Key limitations include reliance on projected market shares for nadofaragene firadenovec, omission of recently approved treatments (nogapendekin alfa inbakicept-pmln and TAR-200) due to the lack of publicly available market share data, and assumptions to derive clinical outcomes for certain treatments due to lack of reported data.

CONCLUSIONS:

Despite its higher acquisition cost, the inclusion of nadofaragene firadenovec resulted in a minimal budget impact as bladder-sparing option for patients with BCG-unresponsive NMIBC with CIS ± Ta/T1.

2026-09-01·Translational Oncology

Can manual gemcitabine instillation or tumor microenvironment-based selection enhance the efficacy of TAR-200 in bladder cancer?

Letter

作者: Chen, Lei ; Liang, Chaozhao

TAR-200, a novel intravesical drug delivery system, has demonstrated remarkable efficacy in patients with BCG-unresponsive non-muscle-invasive bladder cancer, achieving a complete response rate of 82.4% in the phase IIb SunRISe-1 study. In this letter, we propose two strategies to further optimize treatment outcomes. First, we suggest that a single manual gemcitabine instillation given concurrently with TAR-200 placement-without adding an extra procedure - could combine the high peak concentration of manual instillation with the sustained release profile of TAR-200, potentially enhancing antitumor activity. Second, we discuss the immunological mechanisms underlying BCG failure, particularly the development of an immunosuppressive tumor microenvironment characterized by upregulation of PD-L1 on tumor and immune cells. We hypothesize that assessing baseline or BCG-induced immunosuppressive status may help identify patients who would derive greater benefit from the addition of the PD-1 inhibitor cetrelimab to TAR-200. These considerations warrant further investigation to maximize therapeutic efficacy in this challenging patient population.

2026-08-20·JOURNAL OF CLINICAL ONCOLOGY

Adjuvant Chemotherapy ± Chemoradiotherapy for Adenocarcinoma of the Pancreatic Head: Results of the Radiotherapy Random Assignment of NRG Oncology/RTOG 0848

Article

作者: Van Laethem, Jean-Luc ; Seaward, Samantha A. ; Conlin, Alison ; Regine, William F. ; Kachnic, Lisa A. ; Wu, Abraham J. ; Gillin, Michael T. ; Philip, Philip A. ; Safran, Howard P. ; Goodman, Karyn A. ; Moughan, Jennifer ; Geva, Ravit ; Aljumaily, Raid M. ; DiPetrillo, Thomas A. ; Liles, Darla K. ; Abrams, Ross A. ; Winter, Kathryn A. ; O'Reilly, Eileen ; Wu, Jennifer J. ; Anne, Pramila Rani ; Crane, Christopher H. ; Lowy, Andrew M. ; Guha, Chandan S. ; Ling, Diane C.

PURPOSE:

To assess whether adding fluoropyrimidine sensitized radiotherapy (CXRT) to adjuvant chemotherapy improves overall survival (OS) after curative intent resection of the pancreatic head.

METHODS:

This was a multicenter, randomized phase III, two step trial. Step 1: gemcitabine versus gemcitabine + erlotinib (previously reported). Step 2: random assignment to sixth chemotherapy cycle ± CXRT after five cycles of step 1 chemotherapy without progression. Outcomes of step 2 random assignment are reported here. Assuming 17 months median OS (chemotherapy alone), the sample size was 354 patients (hazard ratio [HR], 0.76, 80% power, one-sided α = .05, 316 OS events). OS/disease-free survival (DFS) were estimated by Kaplan-Meier and arms compared using the log-rank test.

RESULTS:

A total of 354 patients (median age 63, 55% male, 56% performance status, 1) were randomly assigned to chemotherapy (174) or chemotherapy + CXRT (180). Univariable median and 5-year OS (90% CIs) were 2.6 years (2.1-3.1) and 23.1% (17.7-28.6) for chemotherapy alone, and 2.3 years (2.0-2.6) and 27.9% (22.2-33.6) for chemotherapy + CXRT. The OS primary end point was not met (HR, 0.96 [90% CI, 0.79 to 1.18]; one-sided P = .38, two-sided P = .77). Chemotherapy + CXRT was associated with a trend for improved DFS (univariably; HR, 0.82 [95% CI, 0.65 to 1.03]; P = .089), without increase in grade 4/5 toxicities. However, grade 3 toxicity increased (38% v 19%, P < .001). Significantly, treatment by nodal status interactions showed that CXRT improved OS ( P = .0063) and DFS ( P = .014) in node-negative patients.

CONCLUSION:

Overall, the addition of adjuvant CXRT to adjuvant gemcitabine did not statistically significantly improve OS, DFS, or increase grade 4/5 toxicity. For node-negative patients, CXRT improved OS and DFS. These results, if confirmed in studies with current or future systemic therapies, would support the use of adjuvant/neoadjuvant CXRT for node-negative patients.

1,622

项与盐酸吉西他滨相关的新闻（医药）

2026-09-11

·复星医药

复星医药子公司复宏汉霖抗EGFR单抗（HLX07） II期研究结果于《Therapeutic Advances in Medical Oncology》发表

近日，复星医药子公司复宏汉霖自主研发的重组抗EGFR单克隆抗体pimurutamab (HLX07)，针对局部晚期及转移性皮肤鳞状细胞癌（CSCC）的II期临床研究第一部分结果发表于国际肿瘤专业期刊Therapeutic Advances in Medical Oncology。研究结果显示，HLX07单药治疗晚期CSCC展现出积极的疗效与良好的安全性特征，为在更大的患者人群中进一步探索抗EGFR靶向治疗提供了新的循证依据。 ORR达60.0%，展现积极抗肿瘤活性皮肤鳞状细胞癌（CSCC）是常见的皮肤恶性肿瘤之一，约占全部皮肤癌的20%，且全球发病率持续上升1-2。尽管早期患者可通过手术或放疗获得较好预后，但对于无法手术或放疗的局部晚期或转移性患者，其10年生存不足20%，仍存在进一步优化治疗方案的临床需求1，3。目前，晚期CSCC的系统治疗主要包括免疫治疗、化疗及抗EGFR靶向治疗1，4，5。尽管免疫治疗已成为重要治疗选择，但仍有多数患者无法获得应答；化疗的疗效证据则较为有限，迄今尚无系统性化疗药物获批用于晚期CSCC。由于CSCC中EGFR表达广泛且RAS突变率较低，使得EGFR成为潜在的治疗靶点6，7。然而，既往抗EGFR抗体疗效有限，因此，开发疗效和安全性更优的抗EGFR靶向疗法具有重要临床价值。 HLX07是一款新型全人源抗EGFR单克隆抗体。基于既往临床前及早期临床研究结果，HLX07表现出良好的抗肿瘤活性和安全性，并具有较长的半衰期，支持每3周一次给药。本次发表的II期研究进一步探索了HLX07单药治疗局部晚期及转移性CSCC的疗效与安全性。该研究是一项评估HLX07单药在晚期CSCC患者中疗效与安全性的开放、多中心、两部分II期临床试验。本次报道第一部分的结果。研究入组了伴有淋巴结转移或远端转移的晚期CSCC或无法进行手术/无法进行根治性放疗的局部晚期CSCC患者。截至2024年4月30日，共入组31例患者，绝大多数患有转移性CSCC，其中1500 mg组（A组）21例、1000 mg组（B组）10例。B组中60%的患者既往接受过系统性抗肿瘤治疗。研究主要终点为盲态独立中心审查委员会（BICR）评估的客观缓解率（ORR），次要终点包括无进展生存期（PFS）、总生存期（OS）、缓解持续时间（DOR）、疾病控制率（DCR）、至缓解时间以及安全性、药代动力学、免疫原性和生活质量等，并探索疗效与肿瘤EGFR及PD-L1表达水平之间的相关性。长期随访数据展现出优异的抗肿瘤活性与生存获益：基于BICR评估，A组中，经确认的ORR为19.0%，均为部分缓解（PR）；B组中经确认的ORR达到60.0%，其中包括1例完全缓解（CR）。DCR分别为61.9%和100%。A组和B组的PFS分别为4.9个月和7.9个月，DOR分别为5.0个月和7.4个月，OS分别为11.8个月和未达到。良好耐受性与安全性，探索最佳给药剂量 HLX07单药安全性可控，未发现新的安全性信号。研究支持1000 mg作为HLX07进一步临床评价的剂量水平，后续研究也将进一步验证其在晚期CSCC患者中的临床获益，并探索EGFR蛋白表达与治疗获益之间的关系。聚焦未满足临床需求，探索更多肿瘤治疗可能 EGFR在多种实体瘤中普遍高表达，包括非鳞状和鳞状非小细胞肺癌，被认为是肿瘤发生、进展及耐药的重要驱动因素8。值得注意的是，EGFR高表达与EGFR敏感突变并不等同，二者之间的相关性较低9。尤其在sqNSCLC人群中，经典敏感性EGFR突变更为罕见10。这意味着，多数EGFR高表达的鳞癌患者并不携带敏感性EGFR突变，因此难以从EGFR-TKI类靶向药中获益10。尽管近年来，抗EGFR单抗联合化疗在肺鳞癌等疾病的治疗中展现出一定的临床获益基础11，12，以PD-1/PD-L1抑制剂为基础的免疫联合化疗也显著改善了晚期肺鳞癌的一线治疗结局，但整体疗效仍有提升空间，临床上仍亟需新的联合治疗策略13-23。从单药治疗到联合免疫治疗、化疗及ADC，HLX07正通过多元联合策略进一步探索其在EGFR高表达实体瘤中的治疗潜力。目前，HLX07联合抗PD-1单抗H药汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）及化疗一线治疗晚期鳞状非小细胞肺癌（sqNSCLC）患者的II/III期临床研究已在中国完成首例患者给药，并在澳大利亚完成临床试验备案（CTN）。此外，公司自主研发的创新型程序性死亡配体1（PD-L1）抗体偶联药物（ADC）HLX43联合HLX07治疗晚期/转移性实体瘤的Ib/II期临床研究已获中国国家药品监督管理局（NMPA）批准。未来，复宏汉霖将继续秉持“以患者为中心”的初心和理念，通过不断挖掘患者未满足的临床需求，持续夯实更多创新分子的差异化布局，为更多肿瘤患者带来高质量、可负担的新型治疗方案。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化创新生物制药企业，致力于为全球患者提供高品质、可负担的生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域。自2010年成立以来，公司已构建涵盖全球研发、临床、注册、生产及商业化的全产业链平台，拥有全球员工超4,000人，并在中国、美国和日本等多地设有运营及分支机构。依托生物类似药形成的稳健现金流反哺创新研发，复宏汉霖正稳步迈入“全球化2.0”阶段，持续打造可复制、可持续的全球增长模式。截至目前，公司共有10款产品在全球60余个国家和地区获批上市，其中8款已在中国获批。在欧美主流生物药市场，复宏汉霖亦取得多项里程碑式突破，已有4款产品获得美国FDA批准、5款产品获得欧盟EC批准，充分体现了公司在研发体系、质量管理及生产能力方面已全面对标国际最高标准。在创新驱动方面，复宏汉霖依托上海、美国等多地协同布局的研发体系，构建了多元化、平台化的创新技术矩阵，覆盖免疫检查点抑制剂、免疫细胞衔接器（包括多特异性TCE）、抗体偶联药物（ADC）以及AI驱动的早期研发平台等前沿方向。目前，公司拥有50余项处于早期阶段的创新资产，其中约70%具备同类最佳（Best-in-Class）潜力，并在全球同步推进50余项临床研究。核心产品H药汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）作为全球首个获批一线治疗小细胞肺癌和首个获批胃癌围术期适应症的抗PD-1单抗，正加速全球布局，已在全球超50个市场获批上市；同时，多款潜力创新资产，包括PD-L1 ADC HLX43及新表位HER2单抗HLX22（通用名：dulpatatug）正全面推进全球关键性临床研究。依托通过中、欧、美三地GMP认证的生产体系，复宏汉霖已建成总产能达84,000升的生物药生产平台，形成覆盖全球六大洲的稳定供应网络。未来，复宏汉霖将始终坚持以患者为中心，聚焦未满足的临床需求，持续推动创新成果向临床价值与患者可及转化，在全球生物医药创新生态中创造长期而稳健的价值。参考文献 References 1. Wysong A. Squamous-cell carcinoma of the skin. N Engl J Med 2023; 388(24): 2262–2273. 2. Guo A, Liu X, Li H, et al. The global, regional, national burden of cutaneous squamous cell carcinoma (1990–2019) and predictions to 2035. Eur J Cancer Care 2023; 2023(1): 5484597. 3. Jiang R, Fritz M and Que SKT. Cutaneous squamous cell carcinoma: an updated review. Cancers (Basel) 2024; 16(10): 1800. 4. National Comprehensive Cancer Network. Squamous cell skin cancer, NCCN guidelines version 1.2024. NCCN Clinical Practice Guidelines in Oncology, 2024. 5. Stratigos AJ, Garbe C, Dessinioti C, et al. European consensus-based interdisciplinary guideline for invasive cutaneous squamous cell carcinoma: Part 2. Treatment-update 2023. Eur J Cancer 2023; 193: 113252. 6. Cañueto J, Cardeñoso E, García JL, et al. Epidermal growth factor receptor expression is associated with poor outcome in cutaneous squamous cell carcinoma. Br J Dermatol 2017; 176(5): 1279–1287. 14. 7. Maubec E, Petrow P, Scheer-Senyarich I, et al. Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin. J Clin Oncol 2011; 29(25): 3419–3426. 8. Normanno N, De Luca A, et al. Epidermal growth factor receptor (EGFR) signaling in cancer. Gene. 2006;366(1):2–16. DOI: 10.1016/j.gene.2005.10.018. PMID: 16377102. 9. Lindeman NI, Cagle PT, Aisner DL, Arcila ME, Beasley MB, Bernicker EH, Colasacco C, Dacic S, Hirsch FR, Kerr K, Kwiatkowski DJ, Ladanyi M, Nowak JA, Sholl L, Temple-Smolkin R, Solomon B, Souter LH, Thunnissen E, Tsao MS, Ventura CB, Wynes MW, Yatabe Y. Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors: Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018 Mar;142(3):321-346. doi: 10.5858/arpa.2017-0388-CP. Epub 2018 Jan 22. PMID: 29355391. 10. The Cancer Genome Atlas Research Network. Comprehensive genomic characterization of squamous cell lung cancers. Nature 489, 519–525 (2012). https://doi.org/10.1038/nature11404 11. Pirker R, Pereira JR, Szczesna A, et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. 12. Pirker R, Pereira JR, von Pawel J, et al. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 2012 Jan;13(1):33-42. 13. Paz-Ares L, Luft A, Vicente D, et al. Pembrolizumab plus chemotherapy for squamous non-small-cell lung cancer. N Engl J Med 2018; 379: 2040–51. 14. Gogishvili M, Melkadze T, Makharadze T, et al. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial. Nat Med 2022; 28: 2374–80. 15. Paz-Ares L, Ciuleanu TE, Cobo M, et al. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol 2021; 22: 198–211. 16. Johnson ML, Cho BC, Luft A, et al, and the POSEIDON investigators. Durvalumab with or without tremelimumab in combination with chemotherapy as first-line therapy for metastatic non-small-cell lung cancer: the phase III POSEIDON study. J Clin Oncol 2023; 41: 1213–27. 17. Wang J, Lu S, Yu X, et al. Tislelizumab plus chemotherapy vs chemotherapy alone as first-line treatment for advanced squamous non-small-cell lung cancer: a phase 3 randomized clinical trial. JAMA Oncol 2021; 7: 709–17. 18. Ren S, Chen J, Xu X, et al, and the CameL-sq Study Group. Camrelizumab plus carboplatin and paclitaxel as first-line treatment for advanced squamous NSCLC (CameL-Sq): a phase 3 trial. J Thorac Oncol 2022; 17: 544–57. 19. Zhou C, Wang Z, Sun Y, et al. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial. Lancet Oncol 2022; 23: 220–33.2 20. Zhong H, Sun S, Chen J, et al. First-line penpulimab combined with paclitaxel and carboplatin for metastatic squamous non-small cell lung cancer in China (AK105-302): a multicentre, randomised, double-blind, placebo-controlled phase 3 clinical trial. Lancet Respir Med 2024; 12: 355–65. 21. Zhou C, Wu L, Fan Y, et al. Sintilimab plus platinum and gemcitabine as first-line treatment for advanced or metastatic squamous NSCLC: results from a randomized, double-blind, phase 3 trial (ORIENT-12). J Thorac Oncol 2021; 16: 1501–11. 22. Zhou C, Hu Y, Arkania E, et al, and the ASTRUM-004 Investigators. A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004). Cancer Cell 2024; 42: 198–208.e3. 23. Fortunato Ciardiello, Fred R. Hirsch, Robert Pirker, Enriqueta Felip, Christian Valencia, Egbert F. Smit,The role of anti-EGFR therapies in EGFR-TKI-resistant advanced non-small cell lung cancer, Cancer Treatment Reviews, Volume 122, 2024, 102664, ISSN 0305-7372, https://doi.org/10.1016/j.ctrv.2023.102664. 联系方式媒体：pr@fosunpharma.com 投资人：ir@fosunpharma.com

2026-09-10

·BioSpace

Immuneering to Present at the AACR Conference on Pancreatic Cancer, Highlighting Atebimetinib’s Dual Mechanism for Extended Survival

- Expands on previously reported findings in which 84% of evaluable first-line PDAC patients treated with atebimetinib + mGnP maintained or gained weight at three months - - New analyses evaluate the overall survival implications of both preserving body mass and reducing tumor volume - NEW YORK, Sept. 10, 2026 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today announced it will present a poster at the American Association for Cancer Research (AACR) Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development taking place September 25-28, 2026, in San Diego, CA. Poster Presentation Details: Title : Atebimetinib Reduces Tumor Volume and Preserves Body Mass: A Dual Mechanism for Extended Survival in Pancreatic Cancer Presenter : Peter Vu, M.D., MHA, UC San Diego Health Poster Number : A134 Session Date : Saturday, September 26, 2026 Session Time : 6:00 – 8:00 pm PT Location : Indigo CDCH The abstract will be available on the AACR website . Following presentation, the poster will be available on the publications section of Immuneering’s website at . About Immuneering Corporation Immuneering is a late-stage clinical oncology company dedicated to keeping cancer patients alive and helping them thrive, with an initial focus on patients with RAS, RAF, and other MAPK-driven cancers. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors, designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve survival across many cancer indications. The Company is conducting a global randomized pivotal trial, MAPKeeper 301, evaluating atebimetinib in combination with chemotherapy in first-line pancreatic cancer patients. The Company’s development pipeline also includes additional combination opportunities and preclinical stage programs. For more information, please visit . Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer including modified Gemcitabine/nab-paclitaxel (mGnP), and its potential to reduce tumor volume and preserve body mass in pancreatic cancer; the timing and content of planned upcoming presentations; and the potential ability of the three design mechanisms of atebimetinib to shrink tumors durably, improve overall survival and overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we are a late-stage clinical oncology company with a limited operating history and have not completed any registrational clinical trials; we have incurred significant losses, are not currently profitable and may never become profitable; limitations on our cash runway and potential increases in expenditures; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and changing regulatory standards, and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including the uncertainty of whether positive preclinical or early clinical efficacy and safety results are confirmed in later-stage trials, potential delays in activation of trial sites or enrollment of trial participants, or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended June 30, 2026, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Investor Contact: Laurence Watts New Street Investor Relations laurence@newstreetir.com Media Contact: David Caouette dcaouette@immuneering.com

AACR会议ASCO会议

2026-09-09

·BioPharmaDive

Tyra disappoints investors with bladder cancer data

Dive Brief:Shares in Tyra Biosciences declined nearly 20% on Wednesday after the companys experimental bladder cancer drug fell short of Wall Streets expectations in a Phase 2 trial.Tyras drug, a daily pill called dabogratinib, is being tested in people whose tumors were driven to growth by an FGFR3 mutation but havent spread beyond the bladder tissue. Study data revealed Wednesday show that, after three months, 57% of recipients had no visible signs of disease. Company executives had hoped 70% of patients would have this kind of complete response.Tyra is positioning the drug as an alternative to a recently approved medicine called Zusduriand Johnson & Johnsons drug-eluting device Inlexzo, both of which require patients to undergo invasive procedures in the urinary tract. Use of dabogratinib, executives have contended, could prevent recurrence in people who forego those alternative treatments.Dive Insight:Tyra is developing dabogratinib in two types of bladder cancer involving FGFR3 mutations. Drugs targeting FGFR mutations have been approved for patients with more advanced disease. But Tyra seeks to make that kind of therapy available to people with non-muscle invasive disease meaning their cancer hasnt spread beyond the cells lining the bladder earlier, following surgical removal of a tumor. Its also evaluating use in a different urological cancer known as urothelial carcinoma.Should Tyra succeed, it would compete with Zusduri. Marketed by UroGen Pharma, Zusduri is a liquid delivered to the bladder through a catheter. Once there, the drug warms to body temperature, thickens into a gel and gradually releases the chemotherapy mitomycin. Patients have to undergo the procedure once a week for six weeks.Dabogratinib has a convenience advantage in that its a once-daily pill that doesnt require office visits or an invasive procedure. However, Zusduri was associated with a 78% remission rate in testing, setting a high bar for dabogratinib. And though not approved in this specific setting, J&Js Balversa induced complete remissions in 89% of enrolleeswith non-muscle invasive disease in a clinical trial.In a statement, Tyra executives emphasized that dabogratinib appeared more effective in people with a single marker lesion, or tumor left behind after surgery for drug evaluation purposes, compared to those with multiple lesions. Six of the eight enrollees fitting this description reached a complete remission at the highest dose tested.While Tyras market value fell on the results, analysts argued that the findings gave dabogratinib a path to success in a future Phase 3 trial. Tyra plans to test it in the adjuvant setting intended to prevent cancer recurrence, and enroll people without marker lesions.In that context, patients with a single marker lesion in [the Phase 2 trial] represent the closest analog to the intended Phase 3 population, given the relatively low residual disease burden compared with patients harboring multiple lesions, wrote TD Cowen analyst Tyler Van Buren, in a client note.Van Buren and other analysts also praised dabogratinibs safety profile in the trial. The worst side effects, occurring in five patients, were categorized as grade 3, meaning they were severe but not life-threatening. No patients dropped out of the study or paused dosing either. '

临床结果临床2期上市批准临床3期

100 项与盐酸吉西他滨相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01155	盐酸吉西他滨	L01BC05	DB00441

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
非肌层浸润性膀胱肿瘤	美国	Janssen Biotech, Inc.	2025-09-09
卵巢上皮癌	英国	Janssen-Cilag Ltd.	2016-03-11
局部晚期非小细胞肺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
局部晚期胰腺腺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
转移性非小细胞肺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
转移性胰腺腺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
复发性卵巢癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
尿路上皮癌	日本	Eli Lilly & Co.	2008-11-25
膀胱癌	巴西	Libbs Farmacêutica Ltda.	2008-05-26
胆道癌	日本	Eli Lilly & Co.	2001-08-31
淋巴瘤	日本	Eli Lilly & Co.	2001-08-31
卵巢癌	日本	Eli Lilly & Co.	2001-08-31
乳腺癌	美国	Eli Lilly & Co.	1996-05-15
转移性乳腺癌	美国	Eli Lilly & Co.	1996-05-15
非小细胞肺癌	美国	Eli Lilly & Co.	1996-05-15
胰腺腺癌	美国	Eli Lilly & Co.	1996-05-15
胰腺癌	美国	Eli Lilly & Co.	1996-05-15

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
晚期胆道癌	临床3期	美国	因华生技制药股份有限公司	2026-06-09
晚期胆道癌	临床3期	中国台湾	因华生技制药股份有限公司	2026-06-09
复发性弥漫性大B细胞淋巴瘤	临床3期	美国	Hoffmann-La Roche, Inc.	2021-02-23
复发性弥漫性大B细胞淋巴瘤	临床3期	中国	Hoffmann-La Roche, Inc.	2021-02-23
复发性弥漫性大B细胞淋巴瘤	临床3期	澳大利亚	Hoffmann-La Roche, Inc.	2021-02-23
复发性弥漫性大B细胞淋巴瘤	临床3期	比利时	Hoffmann-La Roche, Inc.	2021-02-23
复发性弥漫性大B细胞淋巴瘤	临床3期	丹麦	Hoffmann-La Roche, Inc.	2021-02-23
复发性弥漫性大B细胞淋巴瘤	临床3期	法国	Hoffmann-La Roche, Inc.	2021-02-23
复发性弥漫性大B细胞淋巴瘤	临床3期	德国	Hoffmann-La Roche, Inc.	2021-02-23
复发性弥漫性大B细胞淋巴瘤	临床3期	波兰	Hoffmann-La Roche, Inc.	2021-02-23

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01013649 (NRG Oncology/RTOG 0848, Pubmed \| J Clin Oncol)	临床3期	胰腺腺癌辅助	354	Chemotherapy	壓衊鑰鹹糧製衊蓋襯遞(鑰遞積獵鹹壓糧襯餘築) = 鑰糧憲遞夢衊鬱鑰遞淵窪夢夢餘齋簾醖繭願鏇 (遞製衊鹹簾範艱衊齋壓, 2.1 ~ 3.1) 更多	不佳	2026-08-20
				Chemotherapy + CXRT	壓衊鑰鹹糧製衊蓋襯遞(鑰遞積獵鹹壓糧襯餘築) = 齋衊蓋憲繭選鹹壓醖齋窪夢夢餘齋簾醖繭願鏇 (遞製衊鹹簾範艱衊齋壓, 2.0 ~ 2.6) 更多
NCT04640623 (SunRISe-1, CTgov)	临床2期	非肌层浸润性膀胱肿瘤	220	Cetrelimab (Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease))	製鹽糧鹹範遞醖鬱構廠 = 築廠製窪夢壓鬱簾獵膚簾顧膚選艱壓衊襯遞淵 (窪顧襯窪衊積壓鬱鹽憲, 艱構齋觸願齋選鏇顧艱 ~ 積艱艱範觸繭觸遞廠襯) 更多	-	2026-07-29
				TAR-200 (Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease))	製鹽糧鹹範遞醖鬱構廠 = 觸淵選鬱構願積衊選製簾顧膚選艱壓衊襯遞淵 (窪顧襯窪衊積壓鬱鹽憲, 繭鹹製觸觸餘積窪壓壓 ~ 製齋鏇窪顧範醖夢膚鬱) 更多
NCT02252887 (CTgov)	临床2期	晚期 HER2 阳性乳腺癌 \| HER2阳性转移性乳腺癌	45	Trastuzumab+Gemcitabine+Pertuzumab	構築鹽膚願襯膚艱製鬱 = 衊夢選鑰膚醖醖築糧艱鑰衊鏇鬱蓋廠夢窪積齋 (顧鏇選獵繭鏇簾網衊選, 醖鏇願觸膚襯衊鹽獵艱 ~ 觸鏇範膚夢繭遞選簾構) 更多	-	2026-07-24
NCT03410030 (AA NABPLAGEM, CTgov)	临床1/2期	胰腺导管腺癌 \| 转移性肿瘤 \| 转移性胰腺癌	17	Ascorbic Acid (Ascorbic Acid 25 g/m^2)	築蓋構壓壓齋遞淵選鹹(醖艱襯選範範壓構範鑰) = 顧廠壓繭積膚觸觸糧醖鹹構觸願艱鏇蓋觸淵壓 (獵顧壓衊齋膚艱醖獵築, 66.3) 更多	-	2026-07-23
				Ascorbic Acid (Ascorbic Acid 37.5 g/m^2)	築蓋構壓壓齋遞淵選鹹(醖艱襯選範範壓構範鑰) = 鏇夢網構齋願夢蓋衊願鹹構觸願艱鏇蓋觸淵壓 (獵顧壓衊齋膚艱醖獵築, 62.0) 更多
NCT04669197 (CTgov)	临床2期	胰腺腺癌 \| 胰腺导管腺癌 \| 局部晚期胰腺腺癌	19	Paclitaxel protein bound+Hydroxychloroquine+Gemcitabine+cisplatin	鬱願衊鹽餘夢鹹觸繭鑰 = 襯鏇製餘壓積醖夢鹽簾鏇淵製構鹽構鹽鹹鏇鑰 (鏇淵鬱淵鑰淵鬱積鬱糧, 醖艱積顧壓鹽獵衊艱艱 ~ 窪網醖鹹簾夢鏇糧鬱淵) 更多	-	2026-07-21
ESMO_GI2026 \| ESMO_GCC2026	N/A	胰腺癌一线	156	Gemcitabine-based chemotherapy	鏇製鑰獵築顧選膚遞構(夢夢廠廠膚繭淵醖襯築) = 醖繭夢鹹簾夢蓋遞餘鏇鹽網齋膚壓餘鹽繭糧醖 (醖鹹構鬱遞鏇憲鹽憲鹽 ) 更多	不佳	2026-07-02
				Platinum-based chemotherapy	鏇製鑰獵築顧選膚遞構(夢夢廠廠膚繭淵醖襯築) = 選糧鹹網醖鬱構艱構淵鹽網齋膚壓餘鹽繭糧醖 (醖鹹構鬱遞鏇憲鹽憲鹽 ) 更多
TOPAZ-1 (ESMO_GI2026 \| ESMO_GCC2026)	N/A	晚期胆道癌一线	1,358	Cisplatin, gemcitabine, and durvalumab (TOPAZ-1-in)	衊網淵製鏇觸膚鑰餘蓋(網獵艱艱醖築網顧壓糧) = TOPAZ-1-out patients experienced no significant increase in adverse events compared with the TOPAZ-1-in group. 製襯衊願選遞獵廠衊襯 (壓壓蓋網衊蓋鬱襯憲繭 ) 更多	积极	2026-07-02
				Cisplatin, gemcitabine, and durvalumab (TOPAZ-1-out)
ESMO_GI2026 \| ESMO_GCC2026	N/A	转移性胰腺癌一线 BRCA1 \| BRCA2	26	Gemcitabine plus nab-paclitaxel (GnP)	製積鹹餘製廠衊鹽範廠(選窪襯淵願築餘簾餘構) = 齋襯積鑰願淵夢膚願鹹鹽膚顧觸網夢蓋膚夢鬱 (醖願繭衊廠窪夢壓築鹽 ) 更多	积极	2026-07-02
				modified FOLFIRINOX (mFFX)	製積鹹餘製廠衊鹽範廠(選窪襯淵願築餘簾餘構) = 願鑰鹹鏇壓齋餘艱餘廠鹽膚顧觸網夢蓋膚夢鬱 (醖願繭衊廠窪夢壓築鹽 ) 更多
NCT01862315 (CTgov)	临床2期	不可切除的肝内胆管癌	56	Research blood draws+dexamethasone+Gemcitabine+Floxuridine (FUDR)+oxaliplatin (No Prior Chemo or Responded/Stable With Prior Chemo)	繭糧繭鹹鬱鹹鑰鬱膚齋 = 淵積範糧鏇糧鑰蓋鬱鏇窪鏇鏇構鏇餘獵選憲繭 (網艱網憲夢憲鏇壓壓餘, 觸積窪襯範鑰鬱憲積壓 ~ 廠顧蓋構觸衊鹹鑰積鹽) 更多	-	2026-07-01
				Research blood draws+dexamethasone+Gemcitabine+Floxuridine (FUDR)+oxaliplatin (Patients Who Have Failed Systemic Therapy)	構積淵鑰窪艱艱襯衊鹽 = 遞積製餘網鏇齋繭憲鑰顧蓋衊餘簾簾衊獵繭積 (繭鹽鑰餘簾構壓襯齋鏇, 壓範鑰觸觸願淵願願觸 ~ 願簾構積顧製廠鏇憲壓) 更多
NCT07259317 (TRIDENT, ASCO2026)	临床2期	转移性胰腺导管腺癌一线	60	Relacorilant + nab-paclitaxel + gemcitabine	鹽鏇餘壓壓觸襯憲鹽築(齋醖鏇願顧艱鑰繭鹽夢) = 簾壓膚範糧糧選壓鹽鹽蓋鑰廠範鬱醖鹹積顧鬱 (鹹願齋鬱築壓夢糧繭獵, 24.95 ~ NR) 更多	积极	2026-05-29