Replimune presents positive RP1/RP2 data at ASCO: 32.7% ORR in melanoma, BLA on track for 2H 2024

Replimune Group, Inc.

RP1+nivolumab in anti-PD-1 failed melanoma (n=156) showed 32.7% ORR by investigator; median duration of response >36 months.
In primary resistant patients (n=94) ORR 34%; in anti-PD-1+anti-CTLA-4 progressors (n=66) ORR 27.3%.
RP2 in uveal melanoma (n=17) showed 29.4% ORR and 58.8% DCR as monotherapy or with nivolumab; registration-directed trial planned.
Company expects central review results Q2 2024; BLA submission for RP1 in 2H 2024; Phase 3 IGNYTE-3 to start before BLA.

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