Arcus Biosciences plans to present new casdatifan data on October 20, 2026, covering its investigational kidney cancer drug across initial and later treatments. The investor event will take place in New York City with a live webcast beginning at 8:30 a.m. ET. Arcus announced the schedule on September 22; as of October 18, the planned findings had not yet been presented.
Key Takeaways
- The ARC-20 update will cover casdatifan alone and in combinations for clear cell renal cell carcinoma.
- Planned disclosures include safety, tumor response and survival measures across different treatment settings.
- Casdatifan remains investigational, with two Phase 3 development milestones targeted for late 2026.
Table of Contents
- Casdatifan data will span three treatment settings
- What the planned clinical update will measure
- Phase 3 plans give the presentation a development focus
- Conclusion
Casdatifan data will span three treatment settings
Arcus’s September investor-event announcement outlines updates from ARC-20, a platform study testing the HIF-2α inhibitor in clear cell renal cell carcinoma. Presenters will include company management and Dr. Rana McKay, professor of medicine and urology at the University of California San Diego.
The program covers first-line treatment, used at the outset of care; second-line treatment after an earlier therapy; and later-line treatment. That breadth is central to Arcus’s stated strategy of developing casdatifan for use across the course of the disease, rather than in a single treatment setting.
| Item | Details |
|---|---|
| Casdatifan plus zimberelimab | Planned first-line update: 30 patients, approximately 11 months of median follow-up. |
| Casdatifan plus ipilimumab plus zimberelimab | Planned first-line safety and primary-progression update: approximately 20 patients. |
| Casdatifan plus cabozantinib | Planned second-line efficacy update: 43 patients, at least 18 months and approximately 21 months median follow-up. |
| Casdatifan monotherapy | Planned pooled later-line update: 121 patients, approximately 28 months of median follow-up. |
What the planned clinical update will measure
For first-line combinations, Arcus plans to disclose safety and early efficacy findings for casdatifan plus zimberelimab, alongside safety and primary-progression findings for a three-drug regimen adding ipilimumab. Primary progression measures disease worsening at or before the first assessment.
The second-line update will examine casdatifan plus cabozantinib, including response rates, progression-free survival and early overall survival. Later-line monotherapy disclosures will include overall survival and updated response and progression-free survival results.
These measures answer different questions: tumor response tracks shrinkage, progression-free survival measures time without disease worsening or death, and overall survival tracks how long patients live. The planned presentation is a clinical-development update, not a regulatory approval.
Phase 3 plans give the presentation a development focus
Arcus said safety findings from the first-line three-drug cohort would support starting PEAK-20, a registrational trial evaluating casdatifan plus ipilimumab and nivolumab. Management expected that trial to begin in the fourth quarter of 2026.
The company also expected PEAK-1, its ongoing Phase 3 trial of casdatifan plus cabozantinib in immunotherapy-experienced patients, to complete enrollment by year-end 2026. Both dates are management expectations, not completed milestones.
Casdatifan has not received regulatory approval, and its safety and efficacy have not been established. The forthcoming ARC-20 findings will therefore inform the development program rather than establish a commercial treatment outcome.
Conclusion
The next scheduled development is the October 20 presentation of ARC-20 findings. Beyond that event, attention turns to whether Arcus meets its stated late-2026 targets for PEAK-1 enrollment and the start of PEAK-20.
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