Arcus and Astra hit pause
Arcus reckons its HIF2α inhibitor casdatifan could be more potent than Merck & Co’s Welireg, but has fallen further behind after a pause in the Evolve-RCC02 front-line renal cancer trial. The AstraZeneca-sponsored phase 1b/3 study includes cohorts testing casdatifan alongside Astra’s anti-PD-1 x CTLA-4 MAb volrustomig; Arcus revealed in its third-quarter earnings release that recruitment had been “temporarily” halted after “potential immune-mediated adverse events” were seen in the phase 1b portion. There were no grade 4 or 5 events, but the resulting delay looks like good news for Merck, whose front-line study, Litespark-012, is due to complete next year. That’s testing Welireg plus Keytruda plus Lenvima, so could yet be scuppered by the last drug’s own toxicity problems. A decision on whether Evolve-RCC02 will proceed to phase 3 is due in the second half of 2026. Arcus also hopes to start an early-line study of casdatifan around the same time, “likely in combination with standard of care”. Meanwhile, in post-checkpoint inhibitor patients, Arcus recently began Peak-1, evaluating a casdatifan/Cabometyx combo, versus Cabometyx; here, Merck and Eisai just reported a win in the Litespark-011 study of Welireg plus Lenvima, versus Cabometyx, but only on PFS, with OS still being evaluated.
Notable casdatifan trials in renal cell carcinoma
| Trial | Regimen/setting | Note |
|---|---|---|
| Ph1 Arc-20 | Monotx; late-line | More data due H1 2026 |
| + Cabometyx; IO-experienced pts | More data due mid-2026 | |
| Early-line | First data due H2 2026 from “one or more cohorts” | |
| Ph1b/3 Evolve-RCC02* | + volrustomig; 1st-line | Recruitment paused Oct 2025, following “potential immune-mediated adverse events”; data from ph1b portion and go/no-go decision on ph3 due H2 2026 |
| Ph3 Peak-1 | + Cabometyx; IO-experienced | Began Sep 2025 |
Note: *sponsored by AstraZeneca. Source: OncologyPipeline, company release.
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