Arcus Casdatifan Shows 45% ORR, 15.1-Month PFS and $1B Cash; PEAK-1 Enrollment Underway
Arcus reported updated ARC-20 casdatifan data showing a 45% confirmed ORR and 15.1-month median PFS in late-line ccRCC, versus belzutifan’s 5.6-month PFS. It ended Q4 with $1.0B cash, guided 2026 GAAP revenue of $45–55M, and is enrolling its Phase III PEAK-1 casdatifan plus cabozantinib trial.
1. Updated ARC-20 Casdatifan Data
Arcus presented updated results from four late-line monotherapy cohorts in the ARC-20 study showing a confirmed ORR of 45% and a median PFS of 15.1 months after 17.8 months median follow-up, marking the fourth presentation of single-agent data and demonstrating continuous efficacy improvements relative to belzutifan’s 5.6-month PFS.
2. Financial Position and 2026 Outlook
The company concluded Q4 with $1.0 billion in cash following a $288 million financing, guided 2026 GAAP revenue of $45–55 million, expects operating expenses to decline, and maintains sufficient cash to fund operations into at least H2 2028, supporting its late-stage development activities.
3. Phase III PEAK-1 Trial Enrollment
Arcus is actively enrolling its first Phase III PEAK-1 study comparing casdatifan plus cabozantinib versus cabozantinib alone in immunotherapy-experienced ccRCC, aiming to complete enrollment by year-end as part of a fast-to-market, TKI-sparing frontline strategy to reduce early primary progression.