Replimune Presents New Analyses from the IGNYTE Study of RP1 plus Nivolumab in Anti-PD1 Failed Melanoma at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
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- Deep/visceral injections, including into the liver and lung, resulted in numerically higher rates of response compared to superficial injections only and were generally well tolerated -
“The new analyses we presented from the IGNYTE clinical trial of
Key findings are outlined below.
Poster Presentation: Response analysis for injected and non-injected lesions and the safety and efficacy of superficial and deep
- The poster included an analysis from the IGNYTE clinical trial of
RP1 plus nivolumab in the cohort of anti-PD-1 failed melanoma patients (n=140). In the trial, the objective response rate (ORR) was 32.9% using RECIST 1.1. The complete response rate was 15.0% and landmark overall survival (OS) rates at 1, 2, and 3 years were 75.3%, 63.3%, and 54.8% respectively. Median OS has not been reached. - Patients experienced numerically higher objective response rates after receiving deep injections (± superficial) compared with superficial injections only. Deep responses were observed in injected and non-injected lesions.
- The ORR by injection type using RECIST 1.1 was 29.8% when only superficial lesions were injected, 42.9% for deep/visceral plus superficial injections injected, and 40.9% when only deep/visceral lesions were injected.
- There was a ≥30% reduction in 93.6% (73/78) of injected lesions and 79.0% (94/119) of non-injected lesions. The kinetics of response were similar in injected vs non-injected lesions.
- Of the non-injected visceral organ lesions in responding patients, 96.2% (50/52) showed reduction from baseline, with 65.4% reduced by ≥30%.
RP1 injections directly into the lung and liver were generally well tolerated and resulted in few organ-specific adverse events that were easily managed.- Liver and lung injections had a tolerable safety profile.
- No bleeding events were reported after liver injection.
- Lung injections were associated with low rates of pneumothorax events, which were typically of low grade and manageable.
- Overall, these data support the safety and efficacy of deep/visceral injections and demonstrate the development of a robust systemic anti-tumor response following treatment with
RP1 plus nivolumab.
Poster Presentation: Biosafety analysis from the skin cancer cohorts in the IGNYTE clinical trial of
RP1 was assessed in various samples taken from patients.- This demonstrated that
RP1 DNA is primarily detected at the injection site, consistent withRP1 replication in the tumor, and much more rarely on dressings, in blood, on mucous membranes or in urine. - In all cases, live
RP1 was only rarely if ever detected, demonstrating that while residualRP1 DNA may be present, this does not indicate the presence of live RP1 - There were no systemic herpetic infections in patients or reports of HSV-1 infections in contacts.
RP1 is completely neutralized using standard disinfectants within 30 seconds of contact, confirming that standard disinfection procedures are sufficient forRP1 clean-up.
- This demonstrated that
- Collectively these data demonstrate that the likelihood of transmission of
RP1 to patients’ contacts or into the external environment is minimal, with no transmission having been reported to date.
Both posters will be available on the Company website under Events and Presentations.
About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP-R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death and the activation of a systemic anti-tumor immune response.
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