On September 15, 2024 Replimune Group, a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that data from the primary analysis of the IGNYTE clinical trial of RP1 combined with nivolumab were presented by Caroline Robert, M.D., Ph.D. of Gustave Roussy as a late breaking abstract during an oral session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona (Press release, Replimune, SEP 15, 2024, View Source [SID1234646617]).

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"We are excited to share the full IGNYTE primary analysis data which clearly shows clinically meaningful and durable systemic anti-tumor activity across the enrolled population, with responses in both injected and non-injected tumors, including visceral lesions," said Kostas Xynos, MD, PhD, MBA, Chief Medical Officer of Replimune. "These positive data will form the basis of our upcoming BLA submission for RP1 in anti-PD1 failed melanoma in the 2H 2024, which is an important step forward as we continue to progress RP1 plus nivolumab as a potential new option in a setting with only limited treatments currently available."

The anti-PD1 failed melanoma cohort from the IGNYTE clinical trial included 140 patients who received RP1 plus nivolumab after confirmed progression while being treated for at least 8 weeks with anti-PD1 based therapy (+/- anti-CTLA-4). The primary analysis by blinded independent central review was triggered once all patients had been followed for at least 12 months. Because of requirements that patients must have confirmed progressive disease on an immediate anti-PD1-based therapy, which is the current first line standard of care, most of the patients enrolled had 1 (45.7%) or 2 (18.6%) lines of prior therapies.

Results from the IGNYTE clinical trial presented at ESMO (Free ESMO Whitepaper) show:

The overall response rate (ORR) was 33.6% by modified RECIST (mRECIST) 1.1 criteria, the primary endpoint as defined in the protocol, and 32.9% by RECIST 1.1 criteria, an additional sensitivity analysis requested by the FDA.
The complete response rate by mRECIST was 15%.
In patients who had prior anti-PD1 and anti-CTLA-4, the ORR was 27.7% and for those who had primary resistance to anti-PD1, the ORR was 35.9% by mRECIST.
Median duration of response from response initiation was 21.6 months and media duration of response from treatment initiation was 27.6 months. At the time of the analysis, 85% of responses were ongoing more than a year from starting treatment.
While median overall survival has not been reached, one-, two- and three-year survival rates were 75.3%, 63.3% and 54.8% respectively.
RP1 combined with nivolumab continues to be well-tolerated. Treatment-related adverse events associated with RP1 in combination with nivolumab were predominantly Grade 1-2 constitutional type events (> 5% of patients), including fatigue, chills, pyrexia, nausea, influenza-like illness, injection-site pain, diarrhea, vomiting, headache, pruritis, asthenia, arthralgia, myalgia, decreased appetite, and rash, with a low incidence (12.8% of patients) of Grade 3-4 events, which were predominantly Grade 3. Grade 4 events were one each of lipase increased, cytokine release syndrome, myocarditis, hepatic cytolysis and splenic rupture. There were no Grade 5 events.

The presentation is available on the Company website under Events and Presentations.

About RP1
RP1 (vusolimogene oderparepvec) 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.