Replimune reports positive IGNYTE primary analysis: ORR 33.6% in anti-PD1 failed melanoma; BLA submission planned 2H2024

Replimune Group, Inc.

Primary analysis shows ORR 33.6% (modified RECIST 1.1) and 32.9% (RECIST 1.1) by independent central review; all responses >6 months, median DOR >35 months.
BLA submission intended for 2H2024; confirmatory IGNYTE-3 trial first patient expected Q3 2024.
Safety: predominantly Grade 1-2 constitutional events; no Grade 5 events; low incidence of Grade 3-4 incidents.
Data improves on investigator-assessed results presented at ASCO 2024; FDA-requested RECIST 1.1 analysis included.

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