Obsidian Therapeutics to Present Updated Amsoki-cel Efficacy and Pooled Safety Data in Advanced Melanoma at SITC 2026 Annual Meeting
Key Highlights
- ➤Amsoki-cel ORR reached 67% at RP2D, including 2 complete and 8 partial responses
- ➤Amsoki-cel median PFS was 8.3 months; median response duration was not reached
- ➤Five of 15 RP2D patients remained in deep, ongoing response at 12 months
- ➤Pooled safety set reported no DLTs, treatment-related mortality, ICANS or ICU transfers
- ➤Registration-enabling Agni-01 cohort topline data expected by year-end 2027
Expert Statements
Rodabe Amaria, Lead author and presenter; Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center
“These updated data, including promising efficacy, durability, and safety, in patients with ICI-resistant advanced melanoma continue to underscore amsoki-cel’s potential as a meaningful treatment option for patients”
Rodabe Amaria, Lead author and presenter; Professor of Melanoma Medical Oncology at The University of Texas MD Anderson Cancer Center
“The less burdensome treatment approach, including option for minimally invasive CNB tumor tissue procurement, low-dose lymphodepletion compatible with outpatient administration and no IL2, has the potential to make TIL therapy more accessible, while still delivering durable clinical benefit.”
Parameswaran Hari, Chief Medical Officer of Obsidian
“The updated results from the Agni-01 study, including a mPFS of 8.3 months and mDOR that has not yet been reached at median study follow-up of 14.3 months, further reinforce amsoki-cel’s potential in patients with ICI-resistant advanced melanoma.”
Parameswaran Hari, Chief Medical Officer of Obsidian
“We are particularly encouraged by the durability, including 33% of all patients treated at RP2D with ongoing responses at the one-year mark, and continued deepening of responses over time”
Parameswaran Hari, Chief Medical Officer of Obsidian
“Enrollment in the registration-enabling cohort of our multicenter study is ongoing and expected to complete by the end of the first quarter of 2027. We look forward to reporting topline data by year-end 2027.”
Obsidian Therapeutics to Present Updated Amsoki-cel Efficacy and Pooled Safety Data in Advanced Melanoma at SITC 2026 Annual Meeting
* Amsoki-cel ORR was 67% at RP2D (n=10/15), including 2 CRs and 8 PRs; 5 responses remain ongoing, including both CRs and 2 PRs with 100% SOD reduction (one of which deepened since the abstract data cutoff)
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