Immunocore converts TEBE-AM to registrational Phase 3 evaluating KIMMTRAK for cutaneous melanoma

Immunocore Holdings plc

Trial converted to Phase 3 registrational after FDA consultation; three arms: KIMMTRAK monotherapy, KIMMTRAK+pembrolizumab, control.
All patients randomized from trial start included in Phase 3 intent-to-treat population; time to final OS analysis expected to accelerate.
Phase 3 to test KIMMTRAK in previously treated advanced cutaneous melanoma; rapid accrual made Phase 2 OS maturity timeline moot.
Phase 1b data showed ~75% one-year OS rate for KIMMTRAK+checkpoint combo in metastatic cutaneous melanoma patients.

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