Replimune Presents Positive Data from RP1 and RP2 Clinical Programs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Core Insights - Replimune Group, Inc. presented promising clinical data for its RP1 and RP2 programs at the 2024 ASCO Annual Meeting, highlighting their potential in treating hard-to-treat tumor types [1][2] Group 1: RP1 Clinical Trial Results - The IGNYTE clinical trial of RP1 combined with nivolumab in anti-PD-1 failed melanoma showed an overall response rate (ORR) of 32.7% with durable responses lasting over six months, and a median duration of response exceeding 36 months [3][4] - Among patients with primary resistance to prior anti-PD-1 therapy, the ORR was 34%, while those who progressed on prior anti-PD-1 combined with anti-CTLA-4 therapy had an ORR of 27.3% [3] - The safety profile of the combination therapy was favorable, with generally transient grade 1/2 adverse events indicating systemic immune activation [3][5] Group 2: RP2 Clinical Trial Results - RP2, administered alone or in combination with nivolumab in metastatic uveal melanoma patients, demonstrated an ORR of 29.4% and a disease control rate (DCR) of 58.8% [6] - The safety profile of RP2 was favorable, with evidence of immune cell infiltration and increased PD-L1 expression in tumors [6] - Replimune is finalizing a protocol for a registration-directed study based on the encouraging results observed in a historically challenging patient population [6] Group 3: Future Plans and Regulatory Pathway - The company is on track to submit a biologics license application (BLA) for RP1 to the FDA in the second half of 2024 [4] - A Phase 3 confirmatory study (IGNYTE-3) has been agreed upon with the FDA and is expected to be initiated prior to the BLA submission [4]