Obsidian Therapeutics reports updated amsoki‑cel melanoma data with 67% response and 33% ongoing at 12 months

Obsidian Therapeutics presented updated results from its Phase 1/2 Agni‑01 study of amsoki‑cel in advanced melanoma. Fifteen patients treated at the recommended phase‑2 dose showed a 67% objective response rate, including two complete responses, and five patients (33%) remained in deep, ongoing response at the 12‑month landmark. Median progression‑free survival was 8.3 months with a median follow‑up of 14.3 months, and the safety profile was favorable with no dose‑limiting toxicities. The company expects topline data from the registration‑enabling cohort by the end of 2027.

The strong early efficacy and durability could increase investor confidence in Obsidian’s TIL platform and support the upcoming 2027 topline readout, potentially influencing the stock price. The favorable safety profile reduces perceived development risk for the therapy.

  • 1Objective response rate was 67% (10/15 patients) at the recommended phase‑2 dose, including 2 complete responses and 8 partial responses.
  • 2Five patients (33% of 15) remained in deep, ongoing response at the 12‑month landmark.
  • 3Median progression‑free survival was 8.3 months.
  • 4Median study follow‑up was 14.3 months.
  • 5No dose‑limiting toxicities, treatment‑related mortality, ICANS, or ICU transfers were observed in the pooled safety set of 37 patients.
  • 6Topline data from the registration‑enabling cohort of the Phase 1/2 Agni‑01 study are expected by year‑end 2027.

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