This section highlights FDA-related milestones and regulatory updates for drugs developed by Arcus Biosciences (RCUS).
Over the past two years, Arcus Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
casdatifan, STAR-221, ARC-20, and quemliclustat. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Casdatifan FDA Regulatory Events
Casdatifan is a drug developed by Arcus Biosciences for the following indication: In patients with ccRCC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- casdatifan
- Announced Date:
- October 20, 2026
- Indication:
- In patients with ccRCC
Announcement
Arcus Biosciences, Inc announced new data at an investor event in New York City from the ARC-20 platform study, which is evaluating casdatifan, an investigational next-generation HIF-2α inhibitor, alone or in combination, as a first-, second- and late-line treatment for clear cell renal cell carcinoma (ccRCC).
Read Announcement- Drug:
- casdatifan
- Announced Date:
- February 15, 2025
- Indication:
- In patients with ccRCC
Announcement
Arcus Biosciences, Inc today presented new data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in an oral plenary session by Dr. Toni K. Choueiri, Dana-Farber Cancer Institute, at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium.
AI Summary
At the 2025 ASCO Genitourinary Cancers Symposium, Arcus Biosciences presented promising new data for casdatifan, a HIF-2a inhibitor with best-in-class potential. During an oral plenary session led by Dr. Toni K. Choueiri from Dana-Farber Cancer Institute, the company shared results from the Phase 1/1b ARC-20 study. The study focused on patients with metastatic clear cell renal cell carcinoma who had previously received multiple lines of therapy. Notably, the 50mg twice-daily casdatifan cohort achieved a 9.7‐month median progression-free survival with improved overall response rates and disease control compared to earlier HIF-2a studies. The favorable outcomes and manageable safety profile of casdatifan support its potential use as a standalone treatment and in combination therapy, laying the groundwork for future pivotal clinical trials.
Read Announcement
STAR-221 FDA Regulatory Events
STAR-221 is a drug developed by Arcus Biosciences for the following indication: for Metastatic Upper GI Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- STAR-221
- Announced Date:
- December 12, 2025
- Indication:
- for Metastatic Upper GI Cancers
Announcement
Arcus Biosciences, Inc announced the discontinuation of the Phase 3 STAR-221 study, being conducted in partnership with Gilead Sciences, Inc., due to futility.
AI Summary
Arcus Biosciences and partner Gilead announced they are discontinuing the global Phase 3 STAR-221 trial after an independent data monitoring committee (IDMC) found futility at a pre-specified interim overall survival analysis. STAR-221 compared domvanalimab plus zimberelimab and chemotherapy against nivolumab plus chemotherapy as first-line treatment for advanced, HER2-negative gastric and esophageal cancers. The domvanalimab-based regimen did not improve overall survival versus the control, and its safety profile was similar with no new safety signals. The study had enrolled about 1,040 patients.
Arcus and Gilead will stop STAR-221 and the Phase 2 EDGE-Gastric study, notify investigators about patient next steps, and perform detailed analyses to understand the results. Arcus said it is disappointed, thanked participants, and plans to reallocate R&D resources—focusing on casdatifan and inflammatory/autoimmune programs—while continuing to support patients affected by the trial closure. Domvanalimab and zimberelimab remain investigational agents.
Read Announcement- Drug:
- STAR-221
- Announced Date:
- October 12, 2025
- Indication:
- for Metastatic Upper GI Cancers
Announcement
Arcus Biosciences, Inc 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.
AI Summary
Arcus Biosciences announced the first overall survival (OS) results from Arm A1 of its Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. Among 41 treated patients and with a median follow-up of 26.4 months, the combination of domvanalimab (anti-TIGIT), zimberelimab (anti-PD-1), and chemotherapy achieved a median OS of 26.7 months, with half of the patients alive at two years. The regimen also showed a median progression-free survival of 12.9 months and an objective response rate of 59%.
Safety findings were consistent with expectations for anti-PD-1 therapy plus chemotherapy, with no new safety signals. Efficacy was observed across all PD-L1 subgroups, reinforcing confidence in this approach. These encouraging results will be presented at the ESMO 2025 Congress and support the ongoing Phase 3 STAR-221 trial evaluating the same combination in this patient population.
Read Announcement
ARC-20 FDA Regulatory Timeline and Events
ARC-20 is a drug developed by Arcus Biosciences for the following indication: In patients that had received both prior TKI and anti-PD-1 therapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ARC-20
- Announced Date:
- October 6, 2025
- Indication:
- In patients that had received both prior TKI and anti-PD-1 therapy.
Announcement
Arcus Biosciences, Inc announced new monotherapy data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in late-line metastatic clear cell renal cell carcinoma (ccRCC).
AI Summary
Arcus Biosciences announced new monotherapy data for casdatifan, a next-generation HIF-2α inhibitor with best-in-class potential, in patients with late-line metastatic clear cell renal cell carcinoma (ccRCC). The data come from ARC-20, a Phase 1/1b dose-escalation and expansion trial evaluating four monotherapy cohorts (n=121) of heavily pretreated patients.
In a pooled analysis, casdatifan achieved a confirmed overall response rate (cORR) of 31% and a median progression-free survival (mPFS) of 12.2 months—both better than published results for the only marketed HIF-2α inhibitor. In the 100 mg once-daily tablet cohort (the planned Phase 3 dose), cORR was 35%, with mPFS not yet reached after a median follow-up of 12.4 months. The 18-month landmark PFS was 43% in the pooled group.
Casdatifan’s safety profile was acceptable and manageable across all doses, with few discontinuations due to anemia or hypoxia. These promising results support further late-stage development in ccRCC.
Read Announcement- Drug:
- ARC-20
- Announced Date:
- June 1, 2025
- Indication:
- In patients that had received both prior TKI and anti-PD-1 therapy.
Announcement
Arcus Biosciences, Inc today presented the first data for casdatifan plus cabozantinib in an oral presentation by Dr. Toni K. Choueiri, Dana-Farber Cancer Institute, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Arcus Biosciences, Inc. presented the first data for its combination therapy of casdatifan and cabozantinib. Dr. Toni K. Choueiri of the Dana-Farber Cancer Institute highlighted that nearly half of the patients (46%) had a confirmed response after at least 12 weeks of treatment. Casdatifan is a HIF-2a inhibitor and cabozantinib a tyrosine kinase inhibitor, and together they showed a promising overall response rate while maintaining a manageable and predictable safety profile with no significant overlapping toxicities.
The encouraging outcomes from this Phase 1/1b ARC-20 study have paved the way for new trials, including the upcoming PEAK-1 Phase 3 study for immunotherapy-experienced clear cell renal cell carcinoma patients. These findings support further evaluation of this combination as a potential new treatment option for patients with advanced kidney cancer.
Read Announcement- Drug:
- ARC-20
- Announced Date:
- April 23, 2025
- Indication:
- In patients that had received both prior TKI and anti-PD-1 therapy.
Announcement
Arcus Biosciences, Inc announced that data from the ARC-20 study will be presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30 – June 3, 2025.
AI Summary
Arcus Biosciences, Inc. announced that data from the ARC-20 study will be presented during an oral session at the 2025 ASCO Annual Meeting, scheduled from May 30 to June 3, 2025. The presentation, led by Dr. Toni Choueiri of Dana-Farber Cancer Institute, will showcase a more mature data cut that includes safety and initial efficacy results from the Phase 1/1b study. This study focuses on the combination of the HIF-2a inhibitor casdatifan with cabozantinib in patients with clear cell renal cell carcinoma who have previously undergone immunotherapy or VEGFR2-TKI treatments.
In addition, Arcus Biosciences will host a conference call on June 2, 2025, at 5:00 AM PT/7:00 AM CT to discuss the ARC-20 data further. This presentation marks an important step in advancing potential new treatment options for patients battling this form of kidney cancer.
Read Announcement- Drug:
- ARC-20
- Announced Date:
- February 25, 2025
- Indication:
- In patients that had received both prior TKI and anti-PD-1 therapy.
Announcement
Arcus Biosciences, Inc. provided a pipeline update on its clinical-stage investigational molecules across multiple common cancers.
AI Summary
Arcus Biosciences, a clinical-stage global biopharmaceutical company, recently provided an update on its pipeline of investigational molecules targeting multiple common cancers. The update highlighted promising data from the ongoing ARC-20 study, where casdatifan—a HIF-2a inhibitor—demonstrated improved response rates, lower primary progression, and longer progression-free survival in patients with clear cell renal cell carcinoma (ccRCC).
Looking ahead, Arcus plans to initiate the Phase 3 PEAK-1 study comparing a combination of casdatifan and cabozantinib against cabozantinib alone in immuno-oncology experienced ccRCC patients, with the trial expected to begin in the first half of 2025. The company is well-funded, with nearly $1 billion in cash and marketable securities, positioning it strongly to advance its pipeline across various cancer settings.
Read Announcement- Drug:
- ARC-20
- Announced Date:
- February 10, 2025
- Indication:
- In patients that had received both prior TKI and anti-PD-1 therapy.
Announcement
Arcus Biosciences, Inc announced that data from the ARC-20 study will be presented in a rapid oral session at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium taking place February 13 – 15, 2025, in San Francisco, CA.
AI Summary
Arcus Biosciences, Inc. announced that they will present new data from their ARC‐20 study at the 2025 ASCO Genitourinary (GU) Cancers Symposium, which will be held February 13–15 in San Francisco, CA. The presentation is scheduled as a rapid oral session where Dr. Toni Choueiri from Dana-Farber Cancer Institute will share important insights on the safety and effectiveness of casdatifan, a HIF-2a inhibitor. The data includes initial results from the 100mg once-daily tablet cohort—Arcus’ selected dose for upcoming Phase 3 studies—as well as updated results from the 50mg twice-daily and 50mg once-daily cohorts. The ARC‐20 study evaluates casdatifan monotherapy in patients with clear cell renal cell carcinoma who have previously been treated with TKI and anti-PD-1 therapies.
Read Announcement
Quemliclustat FDA Regulatory Events
Quemliclustat is a drug developed by Arcus Biosciences for the following indication: For Pancreatic Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- quemliclustat
- Announced Date:
- July 10, 2025
- Indication:
- For Pancreatic Cancer
Announcement
Arcus Biosciences, Inc announced that quemliclustat, an investigational small molecule CD73 inhibitor, was granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer..
AI Summary
Arcus Biosciences recently announced that the U.S. Food and Drug Administration granted orphan drug designation for quemliclustat, an investigational small molecule CD73 inhibitor, to treat pancreatic cancer. This designation is a significant milestone, as it highlights the importance of developing new treatments for a rare and deadly disease with limited options. Pancreatic cancer remains one of the most fatal cancers, with very few effective therapies emerging over the past 30 years.
The orphan drug status provides key benefits such as tax credits, fee waivers, and potential market exclusivity for up to seven years upon approval. These incentives are designed to support the further development and clinical evaluation of quemliclustat, which is currently being studied as part of the Phase 3 PRISM-1 trial, aiming to improve survival outcomes for patients with metastatic pancreatic cancer.
Read Announcement
