secwatch.observer — SEC 8-K summary
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Issuer:     Replimune Group, Inc. (REPL)
CIK:        0001737953
Form:       8-K
Filed at:   2024-06-03T23:59:59+00:00
Accession:  0001104659-24-067556
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1737953/000110465924067556/0001104659-24-067556-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1737953/000110465924067556/tm2416257d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-067556

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