Arcus Biosciences (NYSE: RCUS) is set to present new clinical data for its investigational therapy casdatifan at the upcoming 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco. The presentation, scheduled for February 13-15, 2025, will focus on results from the ARC-20 study examining casdatifan monotherapy in advanced kidney cancer patients.
Key Clinical Findings from ARC-20 Study
The rapid oral session will highlight safety and efficacy outcomes from three distinct cohorts of patients who had previously received both tyrosine kinase inhibitor (TKI) and anti-PD-1 therapy. Of particular interest will be the initial data from the 100mg once-daily (QD) tablet cohort, which represents the company's selected dose and formulation for their planned Phase 3 clinical program.
Multiple Dosing Regimens Under Investigation
The presentation will also include updated results from two additional dosing cohorts:
- 50mg twice-daily (BID) expansion cohort
- 50mg once-daily (QD) expansion cohort
These multiple dosing regimens are being evaluated to determine the optimal treatment approach for patients with advanced renal cell carcinoma who have progressed on standard therapies.
Strategic Importance for Clinical Development
The selection of the 100mg QD tablet formulation for future Phase 3 studies represents a significant milestone in casdatifan's development program. This decision was likely based on preliminary pharmacokinetic and safety data, though specific details will be revealed during the presentation.
The ASCO GU Symposium presentation will provide crucial insights into casdatifan's potential role in the treatment landscape for advanced kidney cancer, particularly for patients who have exhausted current standard-of-care options. The data from this study will help inform the design and implementation of upcoming Phase 3 trials.
