REPL - Replimune Presents Positive Data from RP1 and RP2 Clinical Programs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting | Benzinga
-- Investigator-assessed 12-month results from the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD-1 failed melanoma demonstrate an overall response rate of 32.7% and duration of response consistent with the previously reported 6-month data from IGNYTE trial --
-- RP2 as monotherapy and in combination with nivolumab in uveal melanoma demonstrates overall response rate of nearly 30 percent; planning for registration-directed trial underway --
WOBURN, Mass., June 03, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today presented two oral presentations highlighting promising clinical data from its RP1 and RP2 programs at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31-June 4 in Chicago.
"The strength of the RP1 and RP2 data being presented at ASCO in two hard-to-treat tumor types further validates the potential of the RPx platform," said Sushil Patel, Ph.D., CEO of Replimune. "In the IGNYTE trial, the investigator-assessed 12-month results show an overall response rate of 32.7% that was highly durable, and the combination provided a favorable safety profile, all consistent with previous data. The data with RP2 as monotherapy and in combination with nivolumab in refractory patients highlights a strong and durable overall response rate of nearly 30 percent in uveal melanoma where treatment options are limited."
Key findings are outlined below.
Oral Presentation: Efficacy and Safety of RP1 Combined with Nivolumab in Patients with anti-PD-1-Failed Melanoma from the IGNYTE Clinical Trial (Session: Melanoma/Skin Cancers; June 3, 2024, 10:57AM CDT; Location: S406; Abstract: 9517)
- The data continues to show that the combination of RP1 and nivolumab in anti-PD-1 failed melanoma (n=156) provides deep and durable responses with an "on-target" safety profile with generally transient grade 1/2 adverse events, indicative of systemic immune activation.
- Approximately one third of patients experienced a response, with an overall response rate (ORR) by investigator assessment of 32.7%.
- In the 94 patients who had primary resistance to their immediate prior anti-PD-1 therapy, the ORR was 34%.
- In the 66 patients who progressed on prior anti-PD-1 combined with anti-CTLA-4 therapy, the ORR was 27.3%.
- All responses lasted greater than six months from enrollment, with a median duration of response exceeding 36 months.
- Clinically meaningful activity was observed across all enrolled subgroups, with over half of patients experiencing either a complete response (CR), partial response (PR) or stable disease (SD).
Primary analysis results by independent central review from the IGNYTE anti-PD-1 failed melanoma cohort ...