Replimune Presents RP1 Data from the IGNYTE anti-PD1 Failed Melanoma Cohort and RP2 Data in Uveal Melanoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting
Updated data from ongoing IGNYTE anti-PD1 failed melanoma cohort shows RP1 combined with nivolumab continues to demonstrate deep and durable responses with a well-tolerated safety profile; no progression in responding patients since the data snapshot presented in December 2022
Overall response rate (ORR) of 37.4%, with clinically meaningful activity across the range of anti-PD1 failed cutaneous melanoma settings enrolled, including in patients with moderate-high tumor burden and visceral disease
RP2 demonstrated an acceptable benefit risk profile and meaningful antitumor activity in patients with uveal melanoma from the ongoing RP2 Phase 1 trial
WOBURN, Mass., June 03, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced updated data from the first 75 patients in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial along with data from the ongoing Phase 1 trial of RP2 combined with nivolumab in patients with uveal melanoma are being presented at the ASCO annual meeting. The anti-PD1 failed melanoma cohort of the IGNYTE clinical trial evaluating RP1 (vusolimogene oderparepvec) in combination with nivolumab is registration-directed.
“We are excited to share further data from these ongoing clinical trials evaluating our novel tumor-directed oncolytic immunotherapies, RP1 and RP2,” said Robert Coffin, President and Chief Research & Development Officer of Replimune. “The IGNYTE data demonstrate RP1 combined with nivolumab provides deep and durable responses with clinically meaningful rates of response in each of the anti-PD1 failed settings enrolled, and further highlights the potent systemic activity in tumors which have not been injected with RP1. These data indicate that RP1 has the potential to become a valuable new treatment option for melanoma patients following progression on anti-PD1 therapy, where treatment options are currently limited. Additionally, the data from RP2 in combination with nivolumab in uveal melanoma demonstrates a promising signal in a challenging tumor type that predominantly metastasizes to the liver, which could unlock additional opportunities for our oncolytic immunotherapies.”
Updated Data from the IGNYTE Clinical Trial Cohort Evaluating RP1 Combined with Nivolumab in anti-PD1 Failed Melanoma
IGNYTE is Replimune’s multi-cohort clinical trial evaluating RP1 combined with nivolumab in multiple tumor type specific cohorts. The anti-PD1 failed melanoma cohort is registration-directed and completed enrollment earlier in the year with 141 patients enrolled. These updated data include the first 75 patients from the anti-PD1 failed melanoma cohort combined with the 16 anti-PD1 failed melanoma patients from the prior all comers 30 patient melanoma cohort (n=91 in total). The IGNYTE clinical trial is being conducted under a collaboration and supply agreement with Bristol Myers Squibb.
The ORR data for this snapshot was investigator assessed. The primary endpoint is ORR for all patients in the cohort which will be assessed by central review.
The poster presented at ASCO can be found on our website under Presentations.
Updated Data from RP2 Combined with Nivolumab in Uveal Melanoma
RP2 leverages the Company’s platform to express an anti-CTLA-4 antibody, in addition to the GALV-GP R- and GM-CSF expressed by RP1. Data in uveal melanoma patients from the Phase 1 clinical trial evaluating RP2 in combination with nivolumab was presented. The Company believes the data in uveal melanoma provides a proxy for the potential treatment of a range of intractable tumor types that metastasize to the liver. This trial is being conducted under a collaboration and supply agreement with Bristol Myers Squibb.
Additional Abstracts Being Presented at ASCO
Three additional trial-in-progress abstracts were presented at ASCO outlining Phase 2 development plans for RP2 and RP3.
These clinical trials are currently in the trial set up phase and are expected to initiate around mid-year.
About RP2 & RP3
Forward Looking Statements
Keynote Presentation by Genesys
Making the Transition from MSP to MSSP
Solutions Showcase Session