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
ARC-20, casdatifan, quemliclustat, and STAR-221. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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
casdatifan - FDA Regulatory Timeline and 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:
- 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- Drug:
- casdatifan
- Announced Date:
- October 9, 2024
- Indication:
- In patients with ccRCC
Announcement
Arcus Biosciences, Inc announced four accepted abstracts at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held October 23-25, 2024, in Barcelona, Spain.
AI Summary
Arcus Biosciences, Inc. announced that four abstracts have been accepted for presentation at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain, from October 23-25. These abstracts highlight key research on their investigational molecules, including casdatifan and AB801. One of the abstracts will be presented in an oral plenary session, showcasing clinical efficacy and safety data from the 100mg daily monotherapy expansion cohort of ARC-20, a Phase 1/1b study evaluating casdatifan in clear cell renal cell carcinoma (ccRCC). Additional posters will detail preclinical evaluations, pharmacokinetics/pharmacodynamics, and the potential of the AXL inhibitor AB801 in sensitizing tumors to standard treatments. Arcus will also host a conference call on October 24 to discuss the ARC-20 results, reinforcing their commitment to advancing innovative cancer therapies with a potential best-in-class profile.
Read Announcement- Drug:
- casdatifan
- Announced Date:
- October 2, 2024
- Indication:
- In patients with ccRCC
Announcement
Arcus Biosciences announced a clinical trial collaboration agreement with AstraZeneca (to evaluate casdatifan (AB521), Arcus's investigational HIF-2a inhibitor, in combination with volrustomig, AstraZeneca's investigational PD-1/CTLA-4 bispecific antibody, in patients with ccRCC.
AI Summary
Arcus Biosciences has announced a new clinical trial collaboration with AstraZeneca to test a promising combination treatment for clear cell renal cell carcinoma (ccRCC), a common type of kidney cancer. The study will evaluate Arcus’s casdatifan (AB521), an investigational HIF-2α inhibitor, together with AstraZeneca’s volrustomig, an experimental PD-1/CTLA-4 bispecific antibody. AstraZeneca will sponsor the trial, which aims to assess the safety and early effectiveness of this combination in patients with advanced ccRCC. Both companies hope that combining these two agents may lead to deeper and longer-lasting responses in patients. The novel approach builds on early encouraging data from previous studies, offering a potential new treatment option for those battling this aggressive cancer. Neither drug has been approved yet, but this collaboration represents a significant step forward in the search for improved therapies for ccRCC.
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quemliclustat - FDA Regulatory Timeline and 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.
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STAR-221 - FDA Regulatory Timeline and 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:
- June 10, 2024
- Indication:
- for Metastatic Upper GI Cancers
Announcement
Arcus Biosciences, Inc announced the completion of patient enrollment for STAR-221, a Phase 3 study in collaboration with Gilead Sciences, evaluating the combination of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.
AI Summary
Arcus Biosciences, Inc. announced the swift completion of patient enrollment for its Phase 3 STAR-221 study. In collaboration with Gilead Sciences, the trial is evaluating a combination therapy for patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The treatment combines domvanalimab, an Fc-silent anti-TIGIT antibody—and the only one currently in Phase 3 for upper GI adenocarcinomas—with the anti-PD-1 monoclonal antibody zimberelimab, alongside chemotherapy. The STAR-221 trial, which has enrolled approximately 1,050 participants, aims to explore overall survival, progression-free survival, and response rates in this challenging patient population. Early enrollment completion, ahead of schedule, underscores the significant global medical interest in this novel anti-TIGIT based regimen, which may offer a new therapeutic option addressing a high unmet need in upper gastrointestinal cancers.
Read Announcement
