- Treatment with casdatifan and cabozantinib showed a 46% response rate in metastatic kidney cancer patients.
- The safety profile is manageable with no significant overlapping toxicity between the drugs.
- The findings support new Phase 3 studies, PEAK-1 and eVOLVE-RCC02, set to commence soon.
Initial results from the ARC-20 study revealed that the combination of Arcus Biosciences’ (RCUS, Financial) investigational drug casdatifan, a HIF-2a inhibitor, with cabozantinib, a tyrosine kinase inhibitor, achieved a confirmed overall response rate (ORR) of 46% in patients with metastatic kidney cancer who had at least 12 weeks of follow-up. These promising results were presented during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting the potential impact on future treatment protocols for clear cell renal cell carcinoma (ccRCC).
The safety profile of the combination therapy was consistent with that of each drug alone, showing no significant overlapping toxicity, which is crucial for patient care. Only two patients discontinued treatment with either drug, and there were no discontinuations of both drugs due to adverse events. Treatment-emergent adverse events (TEAEs), such as anemia and hypoxia, were comparable between combination therapy and casdatifan monotherapy.
These encouraging data pave the way for upcoming Phase 3 clinical trials, namely PEAK-1 and eVOLVE-RCC02. The PEAK-1 trial aims to evaluate the efficacy of casdatifan plus cabozantinib versus cabozantinib monotherapy in the treatment of metastatic ccRCC patients with prior immunotherapy. Meanwhile, eVOLVE-RCC02 will assess casdatifan in combination with volrustomig, an investigational anti-PD-1/CTLA-4 bispecific antibody, for first-line treatment in ccRCC patients.
Arcus Biosciences will host a conference call to discuss these findings on June 2, 2025, at 5:00 AM PT / 7:00 AM CT. Investors and interested parties can join the call via the provided link or by dialing the mentioned numbers.
