预约演示

更新于：2025-09-08

Zimberelimab

赛帕利单抗

更新于：2025-09-08

概要

基本信息

药物类型

单克隆抗体

别名

Zimberelimab (USAN)、重组全人抗PD-1单克隆抗体、AB-122

+ [4]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [7]

在研适应症

PD-L1阳性宫颈癌霍奇金淋巴瘤子宫颈转移癌+ [51]

非在研适应症

晚期头颈癌膀胱癌子宫内膜癌+ [13]

原研机构

哈尔滨誉衡药业股份有限公司

在研机构

吉利德（上海）医药科技有限公司

Arcus Biosciences, Inc.

Gilead Sciences, Inc.

+ [3]

非在研机构

权益机构

Arcus Biosciences, Inc.

+ [5]

最高研发阶段批准上市

首次获批日期

中国 (2021-08-25),

霍奇金淋巴瘤

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (中国)、附条件批准 (中国)

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结构/序列

Sequence Code 452888371H

来源: *****

Sequence Code 616723469L

来源: *****

关联

项与赛帕利单抗相关的临床试验

NCT07134556

/ Not yet recruiting临床2期

A Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as First-line Therapy for PD-L1 Positive Advanced Triple-negative Breast Cancer

The ADJUNCT is a single-arm, phase II clinical trial to evaluate the safety and efficacy of the combination of zimberelimab, domvanalimab and sacituzumab govitecan as first-line therapy for patients with PD-L1 positive advanced or metastatic triple-negative breast cancer.

开始日期2025-12-08

申办/合作机构

Medica Scientia Innovation Research SL

NCT06790706

/ Not yet recruiting临床2期IIT

IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers

Immune checkpoint inhibitors (ICI) have revolutionized the management of advanced cancers. However, most rare cancers have been excluded from this progress due to the lack of clinical trials involving these diseases. After the standard first-line treatment, there are no other validated treatments for most of them. The management of these patients in ≥ 2nd line treatment relies on historic poorly effective regimens.
This creates an inequity between patients with frequent cancers beneficiating from medical progresses and approvals of innovative drugs, and patients with rare cancers are still treated with old and toxic drugs.
Few available data on case reports and early phase studies indicate a beneficial role of the immunotherapy in rare cancers.
The investigators assume that the combination of Domvanalimab and Zimberelimab is more effective than historical standard treatments in patients with 5 types of advanced rare cancers, after failure of at least one line of standard treatment in the advanced setting:
* Cohort 1: Peritoneal Mesotheliomas (PM)
* Cohort 2: Gestational Trophoblastic Tumors (GTT)
* Cohort 3: B3 Thymomas and Thymic Carcinomas (TET)
* Cohort 4: Refractory Thyroid Carcinomas (ATC)
* Cohort 5: GEP-NET and carcinoid tumors (GEP-NET (Gastroenteropancreatic neuroendocrine tumors)/TCT (Thoracic carcinoid tumor)/UP-NET (Neuroendocrine tumor of unknown primary))
The primary objective is to assess the efficacy of the combination of Domvanalimab and Zimberelimab in terms of progression-free survival rate at 24 weeks (for cohorts 1,3,5), successful hCG (Human Chorionic Gonadotropin) normalisation rate at 24 weeks for cohort 2 and survival rate for cohort 4.
The secondary objectives are to assess the efficacy of the combination of anti-TIGIT (T cell Immunoreceptor with Ig and ITIM domains) and anti-PD-1 (Programmed Death-1) immunotherapies in terms of overall response rate, progression-free survival (cohort 1-3 and 5), resistance-free survival (cohort 2), overall survival (cohorts 1-3 and 5), duration of the response (cohorts 1-3 and 5); and to assess the tolerability of the doublet of immunotherapy in terms of adverse events.
Patients will be treated until disease progression or alternatively 2 years in case of complete response (upon discussion with the coordinator of the study, the coordinator of the cohort and the investigator), unacceptable toxicity, or death. At the end of treatment, patients will be followed up for at least 1 year.
IMMUNORARE5 is composed of five independent open-label national multicenter single-arm phase II trials, sponsored by Lyon University Hospital, led in collaboration with the corresponding French national reference centers, with a centralized coordination by a dedicated team.
Each phase II trial is designed as a two-stage Simon design, with early termination for futility. For each cohort, a null hypothesis (H0) and an alternative hypotheses (H1) regarding the percentages of patients with success has been defined, with 5% one-sided alpha level and 80% power.
The trial will be conducted in 15 French Centers with an inclusion period of 36 months

开始日期2025-05-01

申办/合作机构

Hospices Civils de Lyon

NCT06250036

/ Recruiting临床2期IIT

A Randomised Phase II Study of Zimberelimab Anti-PD1 immunOtherapy +/- Domvanalimab Anti-TIGIT Immunotherapy in Resectable Mismatch Repair Deficient Gastric and Gastro-oesophageal Junctional AdenoCarcinoma

A phase II study of peri-operative anti-PD1 (Zimberelimab) +/- anti-TIGIT (Domvanalimab) in resectable mismatch repair deficient (MMRd)/ high micro-satellite instability (MSI-H) gastric/gastro-oesophageal junctional (GOJ) adenocarcinoma (AC)

开始日期2025-02-20

申办/合作机构

Royal Marsden NHS Foundation Trust

[+1]

100 项与赛帕利单抗相关的临床结果

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100 项与赛帕利单抗相关的转化医学

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100 项与赛帕利单抗相关的专利（医药）

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项与赛帕利单抗相关的文献（医药）

2025-09-01·British Journal of Pharmacology

Casdatifan (AB521) is a novel and potent allosteric small molecule inhibitor of protumourigenic HIF‐2α dependent transcription

Article

作者: Malgapo, Martin Ian P. ; Zepeda‐Carranza, Bryan ; Meleza, Cesar ; Piovesan, Dana ; Lawson, Kenneth V. ; Zhao, Xiaoning ; Singh, Jaskirat ; Northington, Kyle R. ; Mitchell, Casey G. ; Rocha, Lauren ; Walters, Matthew J. ; Zhu, Wandi S. ; Ray, Rebecca D. ; Sivick, Kelsey E. ; Lopez Espinoza, Alejandra Y. ; Schweickert, Patrick G.

Abstract:

Background and Purpose:

Hypoxia‐inducible factor 2α (HIF‐2α) is a transcription factor that mediates the expression of genes critical for cell adaptation and survival in low oxygen (hypoxic) conditions. In cancer, hypoxic conditions or molecular alterations within cancer cells can lead to HIF‐2α accumulation and promote tumour growth and progression. Inactivating mutations in the von Hippel–Lindau (VHL) gene disable the oxygen‐dependent HIF‐2α degradation pathway and cause constitutive HIF‐2α activity. VHL mutations are prevalent in clear cell renal cell carcinoma (ccRCC) where HIF‐2α is a known tumourigenic driver. HIF‐2α inhibition was shown to improve ccRCC patient outcomes clinically, warranting development of next‐generation inhibitors.

Experimental Approach:

Pharmacological effects of a novel small molecule allosteric inhibitor of HIF‐2α, AB521 (casdatifan), were evaluated using in vitro cell‐based assays and in vivo mouse models.

Key Results:

AB521 inhibited HIF‐2α‐mediated transcription in cancer cells, endothelial cells, and M2‐polarised macrophages. AB521 was selective for HIF‐2α, displaying no activity against HIF‐1α, and did not exhibit off‐target cytotoxicity. When delivered orally to mice, AB521 caused dose‐dependent decreases in HIF‐2α‐associated pharmacodynamic markers and significant regression of human ccRCC xenograft tumours. AB521 combined favourably with cabozantinib, a standard of care tyrosine kinase inhibitor, or zimberelimab, a clinical‐stage anti‐PD‐1 antibody, in ccRCC xenograft studies.

Conclusions and Implications:

AB521 is a potent, selective and orally bioavailable HIF‐2α inhibitor, with favourable pharmacological properties, that is being explored clinically for the treatment of ccRCC.

2025-06-01·MedComm

Phase II Trial of Hypofractionated Radiotherapy and Immunochemotherapy in Primary Refractory Diffuse Large B‐Cell Lymphoma: Preliminary Results and Insights from Digital Spatial Profiling

Article

作者: Chen, Cheng ; Lin, Yu‐Ping ; Zhao, Rui‐Zhi ; Liao, Si‐Qin ; Fu, Hai‐Ying ; Yu, Jing ; Tang, Tian‐Lan ; Liu, Tian‐Xiu ; Wang, Ying ; Yang, Yong ; Chen, Si‐Lin ; Guo, Jiang‐Rui ; Hu, Xiao‐Mei ; Huang, Cheng ; Chen, Jin‐Hua ; Zheng, Hao ; Liu, Ting‐Bo

ABSTRACT:

This open‐label, single‐arm phase II study assessed the safety and efficacy of sequential hypofractionated radiotherapy (RT) followed by zimberelimab and R‐GemOx (rituximab, gemcitabine, oxaliplatin) in patients with primary refractory diffuse large B‐cell lymphoma (DLBCL). Fourteen patients were enrolled between June 2022 and December 2023, with 13 included in the analysis. RT doses of 36 and 24 Gy were delivered to the gross and target volumes in 12 fractions, followed by zimberelimab and R‐GemOx. The overall response rate within the irradiated field was 92.3%, and a complete response (CR) was achieved by 61.5% of patients; however, 38.5% experienced disease progression. Treatment‐related toxicities were manageable, primarily comprising mild leukocytopenia. Digital spatial profiling revealed 53 differentially expressed genes in CD20‐rich lymphoma regions and 93 in CD3‐rich T cell regions in non‐CR patients. Reactome analysis identified key immune system pathways. T cell infiltration correlated with treatment efficacy, and multiplex immunohistochemistry validated immune pathways as potential therapeutic targets. This study demonstrated the promising role of RT combined with immunochemotherapy in refractory DLBCL and suggests immune pathways as critical targets to improve treatment outcomes.

2025-02-01·LEUKEMIA RESEARCH

Long-term follow-up of zimberelimab in relapsed or refractory classic Hodgkin lymphoma: Insights from the phase Ⅱ YH-S001-04 clinical trial

Article

作者: Lin, Ningjing ; Liu, Zhuogang ; Xu, Bing ; Zhao, Xielan ; Wang, Li ; Zang, Aimin ; Jiang, Yongsheng ; Zhang, Ying ; Zhang, Zhihui ; Ke, Xiaoyan ; Zhou, Hui ; Zhang, Huilai ; Hu, Chunhong ; Liu, Hui ; Yan, Dongmei ; Cui, Jie ; Qi, Junyuan ; Zhang, Mingzhi ; Shao, Zonghong ; Shi, Jinsheng ; Kan, Suisui ; Yang, Shenmiao ; Liu, Lihong ; Xiang, Ying ; Bai, Hai

BACKGROUND:

Treating relapsed or refractory classical Hodgkin lymphoma (R/R cHL) remains challenging. This report extends the three-year follow-up period for the phase Ⅱ YH-S001-04 trial, expanding upon the initial 15.8-month analysis.

METHODS:

Zimberelimab 240 mg was administered every two weeks for two years or until disease progression or death. The endpoint was the objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

The median follow-up was 38.0 months (3.5-42.8 months). The ORR was 91.6 % (95 % CI, 83.8-95.9). Median PFS was 23.6 months, with a longer PFS in responders (28.5 months) compared to non-responders (9.2 months) (P=0.0098). Complete responders had longer mPFS than partial responders (Not reached vs. 28.5 months, P=0.3469). Relapsed patients had improved mPFS compared to refractory cHL (23.6 vs. 10.6 months, P=0.0061). Patients with ＜3 lines of therapy showed longer mPFS compared to ≥3 lines (not reached vs. 23.6 months, P=0.0095). The 3-year OS rate was 94.0 % (95 % CI, 85.9-97.4). No serious adverse events with incidence >5 %.

CONCLUSIONS:

With encouraging data on both PFS and OS, zimberelimab demonstrates ongoing efficacy and safety in treating R/R cHL, supporting zimberelimab as an effective treatment alternative for R/R cHL (NCT03655483).

242

项与赛帕利单抗相关的新闻（医药）

2025-09-05

·GlobeNewswire-Health Care

HUTCHMED Highlights Clinical Data to be Presented at the 2025 World Conference of Lung Cancer and the CSCO Annual Meeting 2025

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 05, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the 2025 World Conference on Lung Cancer (“WCLC”) taking place on September 6-9, 2025 in Barcelona, Spain, and the Chinese Society of Clinical Oncology (“CSCO”) Annual Meeting 2025, taking place on September 10-14, 2025 in Jinan, China. Updated analysis from savolitinib’s SACHI, SAVANNAH and a Phase IIIb confirmatory study in non-small cell lung cancer (“NSCLC”) patients will be presented at WCLC 2025. Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor (“TKI”) being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. Details of the WCLC 2025 presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES SAVANNAH: Biomarker Concordance and Acquired Resistance in Patients with EGFRm MET-OverExp and / or Amp NSCLCChristina Baik, University of Washington and Fred Hutchinson Cancer Center, Seattle, USAMA03.03Mini Oral: New Advances in Circulating BiomarkersRoom 06Sunday, September 7, 20253:15 - 4:30PM CESTEfficacy and Safety of Savolitinib in Advanced or Metastatic METex14 NSCLC Patients With or Without Prior ImmunotherapyYongfeng Yu, Shanghai Chest Hospital, Shanghai, ChinaP3.12.48Poster: Metastatic NSCLC – Targeted TherapyTuesday, September 9, 2025Frontline Treatment Duration in MET-Amplified NSCLC After Third-Generation EGFR-TKI Failure: SACHI Study InsightsLijuan Chen, Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, ChinaP3.12.64Poster: Metastatic NSCLC – Targeted TherapyTuesday, September 9, 2025Osimertinib + Savolitinib in EGFRm Advanced NSCLC With MET Overexp And/Or Amp Post-Progression on Osimertinib: SAVANNAH PROsSilvia Novello, University of Turin, San Luigi Hospital, Turin, ItalyPT2.12.04ePoster: Metastatic NSCLC – Targeted TherapyMonday, September 8, 2025INVESTIGATOR-INITIATED STUDIESEfficacy and Safety of Surufatinib, Durvalumab in Combined with Chemotherapy as First-line Treatment of Extensive-stage Small-cell Lung CancerHui Zhang/ Ying Hu, Beijing Chest Hospital, Beijing, ChinaP3.13.22Poster: Small Cell Lung Cancer and Neuroendocrine TumorsTuesday, September 9, 2025 Clinical data of HMPL-653, a novel, selective and potent CSF-1R inhibitor, from a first-in-human Phase I study in patients with tenosynovial giant cell tumor in China will be presented for the first time at the CSCO Annual Meeting 2025. Details of the CSCO Annual Meeting 2025 presentations are as follows: Abstract titlePresenter / Lead authorPresentation detailsSPONSORED STUDIES A first-in-human phase I study of HMPL-653, a CSF-1R inhibitor, in patients with tenosynovial giant cell tumorXiaohui Niu25297Oral SessionFriday, September 12, 202515:00 - 15:12PM HKTINVESTIGATOR-INITIATED STUDIES Fruquintinib Plus Serplulimab as First-Line Therapy in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (nccRCC): Updated Efficacy and Safety from a Multicenter, Single-Arm TrialJiwei Huang/ Wei Xue23258Oral SessionThursday, September 11, 202516:50 - 17:15PM HKTFruquintinib plus camrelizumab combined with paclitaxel liposome and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): updated data from a single-arm, phase II clinical trialTianzhu Qiu/ Yanhong Gu23766Oral SessionFriday, September 12, 202511:20 - 12:00 noon HKTFruquintinib plus chemotherapy as second-line therapy in metastatic colorectal cancer: a multicenter, open-label, phase II clinical trialYongshun Chen22084Poster SessionEfficacy and Safety of Neoadjuvant Fruquintinib plus Toripalimab and Short-Course Radiotherapy (SCRT) for Locally Advanced Rectal Cancer: Updated Results from a Phase II Clinical TrialZhiping Li21915AbstractFruquintinib combined with chemotherapy as first-line treatment for advanced metastatic colorectal cancer: a propensity score-matched comparison of efficacy between a prospective single-arm cohort and a retrospective observational cohortFuxiang Zhou23550AbstractEfficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: a comparison with real-world bevacizumab plus anti-pd-1 and chidamide armMiaomiao Gou23591AbstractPhase ll Clinical Study of Surufatinib Combined with Gemcitabine and Cisplatin Plus Durvalumab/Pembrolizumab Regimen in the Treatment of Advanced Biliary Tract CancerMiaomiao Gou23610Oral SessionFriday, September 12, 202516:53 - 16:59PM HKTA single-arm, Phase Ib/II trial of surufatinib plus KN046 and gemcitabine and nab-paclitaxel as first-line treatment for unresectable advanced pancreatic cancerWenquan Wang/ Liang Liu23783Oral SessionThursday, September 11, 202516:20 - 16:35PM HKTUpdated results of surufatinib plus transarterial embolization versus surufatinib monotherapy in neuroendocrine tumor with liver metastasis: a prospective, randomized, controlled trialDan Cao22652Poster SessionSurufatinib in patients with soft tissue myeloma who have failed first-line standard chemotherapy or anlotinib: a multicenter, prospective, two-cohort, phase II clinical studyYuhong Zhou/ Xi GuoP80Poster SessionEfficacy and Mechanistic Study of the NASCA Regimen (Surufatinib Combined with Camrelizumab, Nab-Paclitaxel, and S-1) in Advanced Pancreatic Cancer Patients with Liver MetastasisGuanghai Dai/ Ru Jia22309AbstractA Phase II, Single-Arm Study of Surufatinib Combined with Zimberelimab and Nab-Paclitaxel in Patients with Advanced Triple-Negative Breast Cancer: Data UpdateCaixia Wang23679AbstractEfficacy and safety of surufatinib combined with gemcitabine, cisplatin and immune checkpoint inhibitor for the treatment of unresectable locally advanced or metastatic intrahepatic cholangiocarcinomaXuetao Shi/ Jingtao Zhong24133AbstractEfficacy and Safety of Surufatinib in Patients with Neuroendocrine Neoplasms: A Multicenter Retrospective StudyJiang Long24294Abstract About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, surufatinib, savolitinib and HMPL-653, the further clinical development for fruquintinib, surufatinib, savolitinib and HMPL-653, its expectations as to whether any studies on fruquintinib, surufatinib, savolitinib and HMPL-653 would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, surufatinib, savolitinib and HMPL-653, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, surufatinib, savolitinib and HMPL-653 for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting –+44 20 3727 1030 / HUTCHMED@fticonsulting.comBen Atwell / Alex Shaw+44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)Brunswick – Zhou Yi+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure LiberumNominated Advisor and Joint BrokerAtholl Tweedie / Emma Earl / Rupert Dearden+44 20 7886 2500 CavendishJoint BrokerGeoff Nash / Nigel Birks+44 20 7220 0500 Deutsche NumisJoint BrokerFreddie Barnfield / Jeffrey Wong / Duncan Monteith+44 20 7260 1000

临床2期免疫疗法临床结果临床1期上市批准

2025-08-08

·Firstwordpharma

Gilead trims assets partnered with Novo Nordisk, Arcus from pipeline

Gilead Sciences has axed half a dozen programmes from its portfolio, including candidates partnered with Novo Nordisk and Arcus Biosciences. The pipeline cull was disclosed in the company's second-quarter financial report on Thursday, when it also announced encouraging early uptake for its HIV prevention shot Yeztugo (lenacapavir) (see – Spotlight On: With Yeztugo's launch off to the races, Gilead ups HIV guidance).The pipeline prioritisation hit four cancer programmes, an experimental infectious disease asset, and Gilead's final metabolic dysfunction-associated steatohepatitis (MASH) hopeful. The drugmaker had been developing a triple-combination MASH treatment in collaboration with Novo Nordisk since at least 2020. The cocktail, comprising the Danish pharma's GLP-1 blockbuster semaglutide along with Gilead's experimental drugs cilofexor and firsocostat, was studied in the Phase II WAYFIND study.The discontinued candidates from Arcus also date back to a 2020 partnership pegged to last a decade. At the time, Gilead paid $175 million upfront and made a $200-million equity investment to co-develop and co-commercialise cancer immunotherapies from Arcus' pipeline — notably, the PD-1 inhibitor zimberelimab and several anti-TIGIT programmes, although the allure of TIGIT has since faded drastically following a number of high-profile setbacks within the class (see – Spotlight On: AstraZeneca leads TIGIT charge as another one bites the dust).In 2021, Gilead exercised options for several additional assets including etrumadenant, a dual adenosine A2a/A2b receptor antagonist, and the small-molecule CD73 inhibitor quemliclustat; both were pruned from the drugmaker's pipeline on Thursday. The partners had been studying etrumadenant in combination with zimberelimab in the Phase II ARC-9 study for metastatic colorectal cancer, while quemliclustat was being evaluated in the Phase II ARC-8 trial in patients with metastatic pancreatic ductal adenocarcinoma, with or without the PD-1 inhibitor. Separate from the Arcus partnership, Gilead also cut two Phase I oncology programmes from its portfolio: MCL1 inhibitor GS-9716 and DGKα inhibitor GS-9911.The sixth asset to get the axe was the oral antiviral obeldesivir, specifically as a treatment for respiratory syncytial virus (RSV) in both children and adults. Gilead's decision to end development in RSV doesn't come as a surprise, as two trials were terminated in June due to "lower than expected" RSV infection incident rates. At the time, Gilead told FirstWord that a 400-person Phase II study of obeldesivir in Marburg virus disease was continuing as planned. The antiviral also failed the Phase III OAKTREE trial last year after it didn't improve time to symptom alleviation versus placebo in non-hospitalised COVID-19 patients without risk factors for severe disease.

临床2期临床3期临床失败免疫疗法

2025-08-07

·FierceBiotech

Gilead hands back one Arcus cancer candidate from $725M deal

Gilead Sciences secured an option on assets including etrumadenant in 2020. \n Gilead Sciences has returned the rights to a cancer candidate it licensed from Arcus Biosciences in a $725 million, multiprogram deal, confirming its retreat from an asset that was deprioritized earlier this year.After the market closed Wednesday, Arcus revealed Gilead returned the license to etrumadenant, an adenosine A2a/A2b receptor antagonist, in June. The news arrived three months after Arcus said it had opted against advancing into phase 3 following talks with the FDA about data on etrumadenant in third-line metastatic colorectal cancer.The talks confirmed a potential path to market for the drug candidate, Arcus said. However, as Arcus CEO Terry Rosen, Ph.D., told analysts on an earnings call in May, “our plans right now are not to move forward at this time, at least.”Gilead continued to list etrumadenant in its pipeline after Arcus dropped plans for a phase 3. However, Gilead has said little about the program this year and quietly handed back the license in June, a move Arcus revealed in its second-quarter earnings. Arcus reported a cumulative catch-up to revenue of $143 million relating to the return of the license and the pausing of development. The return of the license closes off one of Gilead’s chances of generating a return on its big bet on Arcus. Gilead secured an option on assets including etrumadenant in 2020. Eighteen months later, the company paid $725 million to take up its option on etrumadenant and other clinical-phase programs, including Arcus’ anti-TIGIT antibody domvanalimab. Gilead let its option on casdatifan lapse earlier this year.The Big Biotech still has licenses to domvanalimab and the other two assets from the $725 million deal, namely another TIGIT molecule and the CD73 inhibitor quemliclustat. Gilead also retains a license to zimberelimab, the anti-PD-1 antibody that was covered by the original agreement in 2020. A phase 3 trial of quemliclustat became an independent Arcus study as part of tweaks to the deal early last year.

引进/卖出临床3期临床1期临床2期临床终止

100 项与赛帕利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12063	-	-	-

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
PD-L1阳性宫颈癌	中国	广州誉衡生物科技有限公司	2023-06-30
霍奇金淋巴瘤	中国	广州誉衡生物科技有限公司	2021-08-25

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
子宫颈转移癌	临床3期	中国	广州誉衡生物科技有限公司	2023-05-01
食管腺癌	临床3期	美国	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	日本	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	阿根廷	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	澳大利亚	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	比利时	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	巴西	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	加拿大	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	智利	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	法国	吉利德（上海）医药科技有限公司	2022-11-21

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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


NCT06107114 (NCT06107114, ASCO2025)	临床2期	局部晚期鳞状细胞癌新辅助 PD-1	26	Zimberelimab + Cetuximab + Nab-paclitaxel + Cisplatin	蓋築鹽願廠顧鹹餘築蓋(製構襯顧網願積憲構簾) = 蓋憲壓醖範醖鏇範餘製糧顧壓壓構顧選積繭遞 (膚艱醖襯鏇繭積積襯憲 ) 更多	积极	2025-05-30
NCT03655483 (YH-S001-04, Pubmed \| Leuk Res)	临床2期	典型霍奇金淋巴瘤	-	Zimberelimab 240mg	衊鏇網憲糧鏇鹽壓鬱鏇(壓觸齋壓襯齋遞築簾襯) = 觸餘簾範簾築構膚糧願窪窪願鬱遞齋齋選醖壓 (糧餘夢衊築窪鏇鑰簾積, 85.9 ~ 97.4) 更多	积极	2025-02-01
NCT04999761 (ASCO_GI2025) 人工标引	临床1期	转移性食管癌一线	43	Zimberelimab + Futibatinib + cisplatin + fluorouracil	鹹餘糧鑰憲淵範蓋壓廠(鑰鏇簾鹽淵鏇製選選淵) = DLTs were evaluated in the first three pts, and none were reported. 製範膚壓鑰蓋築憲鏇鹽 (鏇鬱壓壓積夢夢鹽淵選 )	积极	2025-01-23
NCT04736173 (ARC-10, BusinessWire) 人工标引	临床1期	PD-L1阳性非小细胞肺癌 PD-L1 High Expression	98	Domvanalimab plus Zimberelimab	選顧夢鑰襯繭遞壓襯糧(鑰遞積繭壓遞襯膚構夢) = 鑰衊構衊醖齋襯壓願獵衊鑰選鹽衊範製鹽顧鏇 (鏇鹹膚繭網衊淵觸襯蓋, 13.7 ~ NE) 更多	积极	2024-11-05
NCT04736173 (ARC-10, BusinessWire) 人工标引	临床1期	PD-L1阳性非小细胞肺癌 PD-L1 High Expression	98	Zimberelimab	選顧夢鑰襯繭遞壓襯糧(鑰遞積繭壓遞襯膚構夢) = 網衊衊壓選窪網廠夢鬱衊鑰選鹽衊範製鹽顧鏇 (鏇鹹膚繭網衊淵觸襯蓋, 7.8 ~ NE) 更多	积极	2024-11-05
NCT05724563 (2024 SITC)	临床2期	肝细胞癌二线 \| 三线	29	Domvanalimab+赛帕利单抗	鏇積遞憲觸顧鏇鏇遞顧(鏇積鑰窪觸繭膚簾廠艱) = 構醖糧餘構鹽範鹽壓齋築積夢鹽鬱壓淵鬱鏇淵 (廠鹽獵繭壓鏇壓艱顧網 ) 更多	积极	2024-11-05
NCT03972722 (phase II study, Pubmed \| Int J Gynecol Cancer)	临床2期	子宫颈转移癌 programmed death ligand-1-positive	105	Zimberelimab 240 mg	積鏇廠齋網簾餘鹹糧窪(簾鏇衊齋鹽餘鬱襯醖鑰) = 19.0% 襯製積願顧願獵繭鏇鑰 (窪獵鬱蓋獵憲壓願築範 ) 更多	积极	2023-12-01
NCT04262856 (ARC-7, Corporate Publications) 人工标引	临床2期	非小细胞肺癌一线	150	zimberelimab	憲構餘遞廠襯廠壓遞鹹(糧顧醖齋壓構構鑰憲醖) = 夢願夢鬱鹽鹹鬱簾廠鏇獵夢鏇鬱網簾鑰鏇構顧 (築積壓網簾製淵製鹽積, 17.9 ~ 44.6) 更多	积极	2023-06-03
NCT04262856 (ARC-7, Corporate Publications) 人工标引	临床2期	非小细胞肺癌一线	150	domvanalimab + zimberelimab	憲構餘遞廠襯廠壓遞鹹(糧顧醖齋壓構構鑰憲醖) = 網廠遞鹽廠蓋襯艱壓鹽獵夢鏇鬱網簾鑰鏇構顧 (築積壓網簾製淵製鹽積, 26.4 ~ 54.8) 更多	积极	2023-06-03
NCT04262856 (ARC-7, ASCO2022) 人工标引	临床2期	转移性非小细胞肺癌一线 PD-L1 High Expression	149	zimberelimab	艱夢衊淵憲構襯積觸積(衊網構顧繭糧壓獵簾遞) = 鬱範憲選醖觸網鏇簾構壓範網醖齋艱構製襯願 (鹹糧簾獵糧餘醖齋膚衊, 15.0 ~ 42.8) 更多	积极	2022-12-20
NCT04262856 (ARC-7, ASCO2022) 人工标引	临床2期	转移性非小细胞肺癌一线 PD-L1 High Expression	149	domvanalimab+zimberelimab	艱夢衊淵憲構襯積觸積(衊網構顧繭糧壓獵簾遞) = 憲製襯遞鹽繭艱衊醖醖壓範網醖齋艱構製襯願 (鹹糧簾獵糧餘醖齋膚衊, 26.3 ~ 56.8) 更多	积极	2022-12-20
NCT03972722 (SITC2022 \| ESMO_IO2022) 人工标引	临床2期	宫颈癌	90	zimberelimab	獵鹽鬱觸衊蓋廠齋製範(壓壓遞積範繭範艱襯顧) = 艱餘製醖艱餘蓋選遞窪襯積鹽製鑰膚積範觸鬱 (鏇鏇壓鹽膚壓鹹夢襯觸, 18.85 ~ 38.22) 更多	积极	2022-12-08
NCT03972722 (CSCO2022)	临床2期	复发性宫颈癌 \| 转移性宫颈癌	105	赛帕利单抗(GLS-010)注射液	鹽遞製醖窪憲鏇齋鹽遞(襯窪襯鏇衊壓網鬱餘糧) = 夢醖觸簾獵糧衊膚糧鏇蓋鬱窪鹽鏇憲餘鏇構簾 (壓醖蓋夢顧鹹獵鹹壓願 ) 更多	-	2022-09-21