Drugs / Zimberelimab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cervical carcinoma 1 milestone | |||||
| Filed | China (NMPA) | — | cervical carcinoma | — | “2022年3月赛帕利单抗宫颈癌适应症上市申请获得药品审评中心受理” gloriabio.com ↗ |
| Filed Hodgkins lymphoma 1 milestone | |||||
| Filed | China (NMPA) | — | Hodgkins lymphoma | — | “2020年1月，誉衡生物递交了赛帕利单抗首个适应症（复发或难治性经典型霍奇金淋巴瘤）的上市申请。” gloriabio.com ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04656535 | Apr 2021 → Mar 2026 overdue | glioblastoma | Yale University | Active not recruiting | No outcome recorded |
| Phase 115 trials | ||||||
| Phase 1 | NCT06759649 | Jan 2025 → Nov 2027 expected | cancer | Compugen Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT06532565 | Jul 2024 → Jun 2028 expected | cancer | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 1 | NCT04892875 | Dec 2023 → Dec 2025 | hypopharynx squamous cell carcinoma, larynx cancer, oral cavity squamous cell carcinoma, oropharynx squamous cell carcinoma | Jennifer Choe | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT06082960 | Oct 2023 → Dec 2026 expected | cancer | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06045286 | Sep 2023 → Sep 2024 | metastasis from malignant tumor of colon | Jiangsu Cancer Institute & Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05536141 | Oct 2022 → Mar 2029 expected | clear cell renal carcinoma | Arcus Biosciences, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT05007782 | Aug 2021 → Dec 2028 expected | neoplasm | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04999761 | Jun 2021 → May 2026 overdue | alveolar soft part sarcoma, biliary tract cancer, colorectal cancer, esophageal cancer +4 | Taiho Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT04772989 | Mar 2021 → Aug 2025 | cervical cancer, diffuse large B-cell lymphoma, esophageal cancer, gastric cancer +4 | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04104672 | Nov 2019 → Jul 2026 | malignant exocrine pancreas neoplasm | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04087018 | Sep 2019 → Jun 2024 | cancer | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03846310 | Apr 2019 → Nov 2024 | non-small cell lung carcinoma | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03628677 | Sep 2018 → Jan 2025 | cancer | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03629756 | Jul 2018 → Aug 2021 | breast cancer, castration-resistant prostate carcinoma, colorectal cancer, cutaneous neuroendocrine carcinoma +8 | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03713905 | Jul 2017 → Feb 2022 | cancer | Guangzhou Gloria Biosciences Co., Ltd. | Completed | No outcome recorded |
| Phase 1/28 trials · 1 met primary | ||||||
| Phase 1/2 | NCT06238921 | Dec 2024 → Feb 2027 expected | triple-negative breast carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05978401 | Aug 2023 → Apr 2025 | non-small cell lung carcinoma | Guangzhou Gloria Biosciences Co., Ltd. | Unknown | No outcome recorded |
| Phase 1/2 | NCT05688215 | Mar 2023 → Dec 2026 expected | pancreatic ductal adenocarcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05759312 | Mar 2023 → Feb 2025 | ovarian clear cell cancer | Fudan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT05419479 | Nov 2022 → May 2026 | pancreatic adenocarcinoma, pancreatic adenosquamous carcinoma | James Cleary, MD, PhD | Suspended | No outcome recorded |
| Phase 1/2 | NCT05909436 | Oct 2022 → Dec 2026 expected | cancer | Guangzhou Gloria Biosciences Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04660812 | May 2021 → Sep 2025 | colorectal cancer | Arcus Biosciences, Inc. | Completed | Met primary |
| Phase 1/2 | NCT04381832 | Jul 2020 → Aug 2024 | castration-resistant prostate carcinoma | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 238 trials · 1 missed | ||||||
| Phase 2 | NCT07424664 | Jun 2026 → Mar 2027 expected | cervical cancer, vaginal neoplasm, vulva cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 2 | NCT07134556 | Apr 2026 → May 2028 | triple-negative breast carcinoma | MedSIR | Withdrawn | No outcome recorded |
| Phase 2 | NCT07337447 | Apr 2026 → Apr 2029 expected | neuroendocrine carcinoma | Hospices Civils de Lyon | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07397611 | Mar 2026 → Jan 2028 expected | renal cell carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07283848 | Feb → Dec 2026 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT06790706 | Oct 2025 → Nov 2028 expected | carcinoid tumor, digestive system neuroendocrine neoplasm, gestational trophoblastic neoplasm, peritoneal mesothelioma +2 | Hospices Civils de Lyon | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06250036 | Feb 2025 → Mar 2027 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Royal Marsden NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 2 | NCT06133517 | Jan 2025 → Jan 2030 expected | infiltrating bladder urothelial carcinoma | Fundación para el Progreso de la Oncología en Cantabria | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06528483 | Dec 2024 → Dec 2026 expected | infiltrating bladder urothelial carcinoma | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06048484 | May 2024 → Apr 2027 expected | pancreatic ductal adenocarcinoma | Gulam Manji | Recruiting | No outcome recorded |
| Phase 2 | NCT06048133 | Mar 2024 → Jul 2026 overdue | cholangiocarcinoma | Nataliya Uboha | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06155396 | Jan 2024 → Jun 2027 expected | cervical cancer | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06166589 | Jan 2024 → Jan 2026 overdue | — | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06107114 | Dec 2023 → Nov 2024 | head and neck squamous cell carcinoma | Xuekui Liu | Unknown | No outcome recorded |
| Phase 2 | NCT06128460 | Dec 2023 → Dec 2025 overdue | cervical cancer | Obstetrics & Gynecology Hospital of Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06055738 | Oct 2023 → Dec 2026 expected | cervical cancer | Tang-Du Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06009029 | Aug 2023 → Jul 2026 overdue | pancreatic neoplasm | Peking University Third Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05915442 | Jul 2023 → Dec 2026 expected | metastatic prostate carcinoma | Catherine Spina | Recruiting | No outcome recorded |
| Phase 2 | NCT05900765 | Jun 2023 → Jun 2025 | classic Hodgkin lymphoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2 | NCT05335941 | Jun 2023 → Sep 2027 expected | metastatic malignant neoplasm, urothelial carcinoma | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05724563 | Jun 2023 → Dec 2027 expected | cholangiocarcinoma, hepatocellular carcinoma | University of Texas Southwestern Medical Center | Active not recruiting | Missed primary |
| Phase 2 | NCT05886634 | May 2023 → May 2027 expected | dedifferentiated liposarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05824468 | May 2023 → Jul 2024 overdue | cervical carcinoma | Sun Yat-sen University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05633667 | Mar 2023 → Sep 2029 expected | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05676931 | Feb 2023 → Dec 2027 expected | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05872724 | Jan 2023 → Jan 2028 expected | cervical cancer | Suzhou Municipal Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05437692 | Jul 2022 → Jul 2024 | cervical cancer | Shanghai Zhongshan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05632848 | Jun 2022 → Oct 2024 | triple-negative breast carcinoma | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 2 | NCT05329766 | Jun 2022 → Jan 2027 expected | digestive system cancer | Arcus Biosciences, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05024097 | Mar 2022 → Dec 2026 expected | rectal cancer | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 2 | NCT05130177 | Mar 2022 → Feb 2026 overdue | melanoma | Diwakar Davar | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05177770 | Jan 2022 → Apr 2023 | castration-resistant prostate carcinoma | Coherus Oncology, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04791839 | Aug 2021 → Oct 2026 expected | non-small cell lung carcinoma | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04736173 | Feb 2021 → May 2027 expected | non-small cell squamous lung carcinoma | Arcus Biosciences, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04262856 | May 2020 → Jul 2025 | non-small cell squamous lung carcinoma | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03972722 | May 2019 → May 2022 | cervical cancer | Guangzhou Gloria Biosciences Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT03655483 | Aug 2018 → Apr 2021 | classic Hodgkin lymphoma | Guangzhou Gloria Biosciences Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT03547973 | Aug 2018 → Apr 2030 expected | urothelial carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 36 trials · 2 missed | ||||||
| Phase 3 | NCT07710885 | Jun 2026 → Apr 2030 expected | biliary tract cancer | Taiho Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06431633 | Feb 2025 → Nov 2031 expected | non-small cell lung carcinoma | Fundación GECP | Recruiting | No outcome recorded |
| Phase 3 | NCT05798819 | Apr 2023 → Dec 2029 expected | — | Guangzhou Gloria Biosciences Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05568095 | Nov 2022 → Aug 2026 | adenocarcinoma | Arcus Biosciences, Inc. | Completed | Missed primary |
| Phase 3 | NCT05502237 | Oct 2022 → Jun 2028 expected | non-small cell lung carcinoma | Gilead Sciences | Active not recruiting | Missed primary |
| Phase 3 | NCT05518318 | Sep 2022 → Jun 2025 | classic Hodgkin lymphoma | Guangzhou Gloria Biosciences Co., Ltd. | Unknown | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT07619313 Background | Jun 2026 → Jun 2027 expected | cholangiocarcinoma, pancreatic ductal adenocarcinoma | Jonsson Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05891171 Background | Oct 2023 → Sep 2027 expected | cancer of unknown primary site, cervical cancer, esophageal cancer, gastric cancer +7 | Arcus Biosciences, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05840224 Background | May 2023 → Jul 2026 overdue | cancer | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04747470 Background | Mar 2021 → Nov 2022 | cancer | Gilead Sciences | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT06727565 Background | Feb 2025 → Mar 2027 expected | head and neck squamous cell carcinoma | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04854499 Comparator | Sep 2021 → Oct 2024 | head and neck squamous cell carcinoma | Gilead Sciences | Terminated | Missed primary Stop: Business |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2026-04-21 | Taiho Oncology, Inc. | Results 非小細胞肺がんに対する抗TIGIT抗体domvanalimabと抗PD-1抗体zimberelimab併用の第III相STAR-121試験について taiho.co.jp ↗
大鵬薬品工業株式会社（本社：東京都千代田区、 代表取締役社長：小林将之、 以下「大鵬薬品」）は、 Arcus Biosciences, Inc. （アーカス・バイオサイエンシズ、 本社：米国カリフォルニア州、 Chief Executive Officer：Terry Rosen、 以下「Arcus社」）およびGilead Sciences, Inc. （ギリアド・サイエンシズ、 本社：米国カリフォルニア州、 Chairman and Chief Executive Officer：Daniel O’Day、 以下「Gilead社」）と実施している転移性非小細胞肺がんの1次治療として、 抗TIGIT抗体domvanalimab （開発コード：AB154）+抗PD-1抗体zimberelimab （開発コード：AB122）+化学療法併用群と、 ペムブロリズマブ+化学療法併用群を比較評価する第III相STAR-121試験について、 有効性が認められなかったことによる中止をお知らせします. |
| 2026-04-21 | Taiho Oncology, Inc. | Results Update on the Phase 3 STAR-121 Study of Anti-TIGIT Antibody Domvanalimab and Anti-PD-1 Antibody Zimberelimab in Non-Small Cell Lung Cancer taiho.co.jp ↗
Taiho Pharmaceutical Co., Ltd. (“Taiho”) today announced the discontinuation of the Phase 3 STAR-121 study due to futility. |
| 2025-12-12 | Arcus Biosciences, Inc. | Results Arcus Provides Update on Phase 3 STAR-221 Study and Concentrates Its R&D Investment on Casdatifan and Emerging Inflammation and Immunology Portfolio arcusbio.com ↗
At the interim analysis, the domvanalimab-based combination did not improve OS relative to that of nivolumab plus chemotherapy. |
| 2025-10-12 | Arcus Biosciences, Inc. | Results Anti-TIGIT Domvanalimab Plus Anti-PD-1 Zimberelimab and Chemotherapy Showed 26.7 Months of Median Overall Survival as First-Line Treatment of Unresectable or Advanced Gastroesophageal Adenocarcinomas in the Phase 2 EDGE-Gastric Study arcusbio.com ↗
today announced the first OS results from Arm A1 of the Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. |
| 2024-11-06 | Arcus Biosciences, Inc. | Results Arcus Biosciences Reports Third-Quarter 2024 Financial Results and Provides a Pipeline Update arcusbio.com ↗
domvanalimab plus zimberelimab reduced the risk of death in first-line metastatic non-small cell lung cancer (NSCLC) by 36% compared to zimberelimab |
| 2024-11-05 | Arcus Biosciences, Inc. | Results Arcus Biosciences Announces that Domvanalimab Plus Zimberelimab Improved Overall Survival in ARC-10, a Randomized Study in Patients with PD-L1-High Non-Small Cell Lung Cancer arcusbio.com ↗
Domvanalimab plus zimberelimab was associated with greater progression-free survival, overall survival, and objective response rate compared with those of zimberelimab or chemotherapy |
| 2024-06-02 | Arcus Biosciences, Inc. | Results Gilead and Arcus Announce Etrumadenant Plus Zimberelimab Regimen Significantly Reduced the Risk of Death in Third-line Metastatic Colorectal Cancer arcusbio.com ↗
In Cohort B of the ARC-9 mCRC Study, Etrumadenant Plus Zimberelimab, FOLFOX Chemotherapy and Bevacizumab Significantly Reduced the Risk of Death by 63% and Risk of Disease Progression by 73% Compared to Regorafenib in a Phase 1b/2 Trial |
| 2024-06-01 | Gilead Sciences | Results Gilead and Arcus Announce Anti-TIGIT Domvanalimab Plus Zimberelimab and Chemotherapy Exceeded One Year of Median Progression-Free Survival as a First-Line Treatment for Upper GI Cancers gilead.com ↗
“I am encouraged to see that patients treated with domvanalimab plus zimberelimab and chemotherapy had a median progression-free survival beyond one year, which exceeds the historical benchmarks for anti-PD-1 plus chemotherapy alone,” said Dr. Janjigian. |
| 2024-06-01 | Arcus Biosciences, Inc. | Results Gilead and Arcus Announce Anti-TIGIT Domvanalimab Plus Zimberelimab and Chemotherapy Exceeded One Year of Median Progression-Free Survival as a First-Line Treatment for Upper GI Cancers arcusbio.com ↗
I am encouraged to see that patients treated with domvanalimab plus zimberelimab and chemotherapy had a median progression-free survival beyond one year, which exceeds the historical benchmarks for anti-PD-1 plus chemotherapy alone, |
| 2024-01-16 | Arcus Biosciences, Inc. | Results Data from a Phase 1b Study of Quemliclustat-Based Regimens Showed Promising Overall Survival in Treatment-Naïve Metastatic Pancreatic Cancer arcusbio.com ↗
Median Overall Survival was 15.7 months for all patients treated with 100 mg quemliclustat-based regimens in the ARC-8 study, which exceeds the historical benchmark data for chemotherapy alone |
| 2023-11-20 | Guangzhou Gloria Biosciences Co., Ltd. | Results 民族之光，誉她芬芳 | 2023 CCHIO妇科肿瘤分会场前沿进展专题会暨赛帕利单抗宫颈癌适应症中国上市会盛大召开！ gloriabio.com ↗
ORR达27.6%，中位OS达16.8个月。 |
| 2023-11-07 | Arcus Biosciences, Inc. | Results Arcus Biosciences Reports Third Quarter 2023 Financial Results and Provides a Pipeline Update arcusbio.com ↗ |
| 2023-11-06 | Arcus Biosciences, Inc. | Results Gilead and Arcus Announce New Data Showing Encouraging Clinical Activity of Anti-TIGIT Domvanalimab-Containing Regimen as First-Line Treatment for Upper GI Cancers arcusbio.com ↗
Preliminary data from Arm A1 of the Phase 2 EDGE-Gastric study showed promising ORR and six-month PFS results, irrespective of PD-L1 expression |
| 2023-10-13 | Guangzhou Gloria Biosciences Co., Ltd. | Regulatory 誉衡生物与荣昌生物PD-1与HER2 ADC联合用药临床研究正式获批 gloriabio.com ↗
开展联合用药临床研究的申请正式获得中国国家药品监督管理局（NMPA）批准。 |
| 2023-09-06 | Guangzhou Gloria Biosciences Co., Ltd. | Regulatory 誉衡生物赛帕利单抗（誉妥®）宫颈癌适应症获NMPA批准上市 gloriabio.com ↗
广州誉衡生物科技有限公司（以下简称“誉衡生物”），一家聚焦肿瘤免疫治疗领域、处于商业化阶段的生物制药公司，宣布公司开发的抗肿瘤新药 誉妥® （ 赛帕利单抗注射液，全人源抗PD-1单克隆抗体 ） 第二个适应症 获得中国国家药品监督管理局（NMPA）批准上市，用于既往接受含铂化疗治疗失败的复发或转移性、PD-L1表达阳性（CPS≥1）的宫颈癌患者。 |
| 2023-06-13 | Guangzhou Gloria Biosciences Co., Ltd. | Regulatory 誉衡生物GLS-012联合赛帕利单抗获批临床 gloriabio.com ↗
近日，誉衡生物公司研发的GLS-012联合赛帕利单抗，再获国家药品监督管理局（NMPA）临床试验许可，适应症为恶性肿瘤。 |
| 2023-06-03 | Gilead Sciences | Results Gilead and Arcus Announce Anti-TIGIT Domvanalimab Continues to Demonstrate Consistent Improvement in Progression-Free Survival in Non-Small Cell Lung Cancer Study gilead.com ↗
Clinically Meaningful Reduction in Risk of Progression or Death Was Observed in the Domvanalimab-Containing Study Arms Compared to Zimberelimab Monotherapy in First-Line, PD-L1-High NSCLC |
| 2023-06-03 | Arcus Biosciences, Inc. | Results Gilead and Arcus Announce Anti-TIGIT Domvanalimab Continues to Demonstrate Consistent Improvement in Progression-Free Survival in Non-Small Cell Lung Cancer Study arcusbio.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced updated results from an interim analysis of the ARC-7 study in patients with first-line, metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥50% without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations. |
| 2022-12-19 | Gilead Sciences | Results Anti-TIGIT Domvanalimab-Containing Study Arms Improve Progression-Free Survival Compared to Anti-PD1 Alone in Phase 2 Non-Small Cell Lung Cancer Study gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) and Arcus Biosciences, Inc. (NYSE: RCUS) today announced positive results from the fourth interim analysis of the ARC-7 study in patients with first-line, metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥50% without epidermal growth factor receptor or anaplastic lymphoma kinase (EGFR/ALK) mutations. |
| 2022-12-19 | Arcus Biosciences, Inc. | Results Anti-TIGIT Domvanalimab-Containing Study Arms Improve Progression-Free Survival Compared to Anti-PD1 Alone in Phase 2 Non-Small Cell Lung Cancer Study arcusbio.com ↗
35-45% Reduction in Risk of Progression or Death and a Doubling of mPFS Were Observed in the Domvanalimab-Containing Study Arms, Compared to Zimberelimab Monotherapy in First-Line, PD-L1-High NSCLC |
| 2022-11-28 | Gilead Sciences | Results Gilead and Arcus Biosciences Announce Positive Update on Joint TIGIT Program From Interim Analysis of ARC-7 Study in Non-Small Cell Lung Cancer gilead.com ↗
Fourth Interim Analysis Shows Continued Clinically Meaningful Differentiation Across All Efficacy Measures, Including PFS, in Both Domvanalimab-Containing Arms Compared to the Anti-PD-1 Zimberelimab Monotherapy Arm in First-Line NSCLC Patients |
| 2022-11-28 | Arcus Biosciences, Inc. | Results Gilead and Arcus Biosciences Announce Positive Update on Joint TIGIT Program From Interim Analysis of ARC-7 Study in Non-small Cell Lung Cancer arcusbio.com ↗
Fourth Interim Analysis Shows Continued Clinically Meaningful Differentiation Across All Efficacy Measures, Including PFS, in Both Domvanalimab-Containing Arms Compared to the Anti-PD-1 Zimberelimab Monotherapy Arm in First-Line NSCLC Patients |
| 2022-05-09 | Arcus Biosciences, Inc. | Results Arcus Biosciences Reports First Quarter 2022 Financial Results and Provides a Pipeline Update, Including from the Third Interim Analysis for the ARC-7 Study arcusbio.com ↗
In this interim analysis, both domvanalimab-containing arms continued to show meaningful differentiation compared to zimberelimab alone across multiple efficacy measures, including overall response rate (ORR) and duration of response (DoR). |
| 2021-11-08 | Arcus Biosciences, Inc. | Results Arcus Biosciences Reports Third Quarter 2021 Financial Results and Provides an Update on our anti-TIGIT Domvanalimab arcusbio.com ↗
Both domvanalimab-containing arms demonstrated differentiated clinical activity compared to that of zimberelimab alone in a second interim analysis of ARC-7, our randomized Phase 2 study in first-line metastatic non-small cell lung cancer (NSCLC) |
| 2021-08-31 | Guangzhou Gloria Biosciences Co., Ltd. | Regulatory 广州誉衡生物科技有限公司全人源抗PD-1单克隆抗体赛帕利单抗获国家药品监督管理局批准上市 gloriabio.com ↗
8月30日，根据国家药品监督管理局（NMPA）官网公示，由广州誉衡生物科技有限公司申报的赛帕利单抗注射液（zimberelimab injection）正式获得了上市批准，用于治疗二线以上复发或难治性经典型霍奇金淋巴瘤。 |
| 2021-08-30 | Ligand Pharmaceuticals | Regulatory Ligand’s Partner Gloria Biosciences Receives Approval in China for Zimberelimab for the Treatment of Recurrent or Refractory Classical Hodgkin’s Lymphoma ligand.com ↗
Ligand’s Partner Gloria Biosciences Receives Approval in China for Zimberelimab for the Treatment of Recurrent or Refractory Classical Hodgkin’s Lymphoma |
| 2021-06-23 | Arcus Biosciences, Inc. | Results Anti-TIGIT Domvanalimab-Based Combinations Showed Encouraging Clinical Activity in People with Metastatic, PDL1-High Non-Small Cell Lung Cancer at First Interim Analysis of Arcus Biosciences’ Randomized Phase 2 ARC-7 Study arcusbio.com ↗
The zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied by other companies in this setting. |
| 2021-05-19 | Arcus Biosciences, Inc. | Results Arcus Biosciences Presents Early Data from ARC-6, a Phase 1b/2 Study Evaluating Etrumadenant-Based Combinations in Metastatic Castrate-Resistant Prostate Cancer at the 2021 ASCO Annual Meeting arcusbio.com ↗
In this Phase 1b cohort of the etrumadenant-based combination, a composite ORR (radiographic and/or PSA [prostate-specific antigen] response) of 41% and a PSA response of 35% were observed. |
| 2021-01-15 | Arcus Biosciences, Inc. | Results Arcus Biosciences Presents Promising Initial Data from Phase 1 Portion of ARC-8 Study for AB680 in Metastatic Pancreatic Cancer arcusbio.com ↗
Across all four dose-escalation cohorts, no significant additive toxicity from AB680 plus NP/Gem plus zimberelimab has been observed beyond that expected from NP/Gem plus anti-PD-1 combined. |
| 2021-01-11 | Arcus Biosciences, Inc. | Results Arcus Biosciences to Present Preliminary Data from Phase 1 Portion of ARC-8 Study for AB680 in Metastatic Pancreatic Cancer at ASCO-GI Symposium arcusbio.com ↗
Preliminary data from the first dose-escalation cohorts, reported in an abstract released today, demonstrate encouraging signs of clinical activity for AB680 in combination with zimberelimab (anti-PD-1 antibody) and chemotherapy |
| 2020-12-24 | Guangzhou Gloria Biosciences Co., Ltd. | Results 续写辉煌启新程 | 赛帕利单抗多项研究成果入选 2020 CSCO年会口头报告、壁报 gloriabio.com ↗
本研究结果表明赛帕利单抗在中国复发或难治性cHL患者中抗肿瘤疗效显著，安全性良好。 |
| 2020-12-12 | Guangzhou Gloria Biosciences Co., Ltd. | Results 看今朝再创新篇 【2020 ASCO】GLS-010 PD-1单抗治疗复发或转移宫颈癌II期临床试验结果入选壁报展示 gloriabio.com ↗
研究表明，GLS-010在中国复发或转移性宫颈癌患者中初步显示出良好的疗效和安全性。 |
| 2020-12-11 | Guangzhou Gloria Biosciences Co., Ltd. | Results 硕果纷呈迎盛会 【2020 ASCO】GLS-010 PD-1单抗治疗经典型霍奇金淋巴瘤注册临床试验结果入选壁报展示 gloriabio.com ↗
结果表明， GLS-010安全性和耐受性良好，在r/r cHL患者中抗肿瘤疗效显著。 |
| 2018-11-09 | Arcus Biosciences, Inc. | Results Arcus Biosciences Presents Initial Data from the Phase 1 Dose-Escalation Study of AB122, its anti-PD-1 antibody, at the SITC 2018 Annual Meeting arcusbio.com ↗
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, today announced preliminary data from its ongoing Phase 1 dose-escalation study of AB122. |
| 2018-06-11 | Arcus Biosciences, Inc. | Regulatory Arcus Biosciences Announces FDA Clearance of INDs for AB928 and AB122 and Initiation of Phase 1/1b Program to Evaluate AB928 Combinations arcusbio.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has cleared Investigational New Drug (IND) applications for the Company’s two most advanced product candidates, AB928 and AB122. |
All press releases naming this drug 39 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 77 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zimberelimab | “Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study.” PMID 37875323 ↗ Dec 202367“Immunotherapy (Zimberelimab) is given every three weeks within one week after the end of high-dose radiotherapy.” NCT06045286 ↗ “GLS-010 (zimberelimab) is a novel, fully human, anti-programmed death-1 monoclonal antibody” PMID 34462189 ↗ Aug 2021 |
| Known as | AB122 | “Zimberelimab (AB 122) Surgical Cohort (Cohort B2)” NCT04656535 ↗4“* Zimberelimab (also known as AB122)” NCT05419479 ↗ “Drug: Zimberelimab (AB122)” NCT07134556 ↗ “Zimberelimab (AB122)” NCT05024097 ↗ |
| Known as | GLS-010 | “In the dose escalation stage of GLS-012 combination with GLS-010, RP2D of GLS-012 in combination with a fixed-dose GLS-010 will be determined.” NCT05909436 ↗7“Zimberelimab (GLS-010),240mg d1 iv Q21D” NCT06009029 ↗ |
| Known as | ZIM | “Zimberelimab (ZIM) + Chemotherapy” NCT05502237 ↗ |
| Action | Inhibit | “Zimberelimab is a fully human anti-PD-1 monoclonal antibody.” NCT03629756 ↗ |
| Modality | Monoclonal antibody | “Zimberelimab is a fully human anti-PD-1 monoclonal antibody.” NCT03629756 ↗ |
| Route | Intravenous | “Administered intravenously” NCT03547973 ↗ |
| Target | PDCD1 | “can specially block the PD-1/PD-L1/2 axis” PMID 33691262 ↗ Mar 2021 |