Arcus Biosciences presents ARC‑20 data showing strong efficacy of casdatifan across kidney‑cancer lines

Arcus Biosciences disclosed new results from its ARC‑20 platform study of the HIF‑2α inhibitor casdatifan in clear‑cell renal cell carcinoma. The data showed a 86% six‑month progression‑free survival (PFS) rate in first‑line, a 14.5‑month median PFS in second‑line with cabozantinib, and a nearly three‑year median overall survival in heavily pre‑treated patients. The company said it will start the registrational first‑line PEAK‑20 trial by year‑end and is enrolling patients for later‑line studies with tivozanib and cabozantinib.

The robust efficacy signals could expand the addressable RCC market, which the company estimates at $5 billion‑$10 billion, and support upcoming Phase III trials that may lead to regulatory approval. Analysts note the data may justify higher price targets, while the mixed short‑term stock reaction reflects market expectations versus the disclosed results.

  • 1In first‑line, casdatifan plus anti‑PD‑1 achieved 86% six‑month PFS and 69% twelve‑month PFS (n=30).
  • 2First‑line confirmed objective response rate was 50% with 6.7% primary progression.
  • 3In second‑line, casdatifan plus cabozantinib yielded a 14.5‑month median PFS (n=43) and 77% 18‑month OS.
  • 4Late‑line monotherapy showed a 35‑month median overall survival with 13‑month median PFS.
  • 5Arcus plans to initiate the first‑line PEAK‑20 registrational trial by the end of 2026.
  • 6The company highlighted a $5 billion‑$10 billion RCC market opportunity at its Investor Day.

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