H.C. Wainwright has maintained its Buy rating and $17.00 price target on Replimune Group (NASDAQ: NASDAQ:REPL) shares.
The decision follows the presentation of full results from Replimune's IGNYTE trial at the ESMO conference in Barcelona, Spain. The trial is focused on evaluating the effectiveness of RP1 combined with Opdivo in patients with melanoma who did not respond to anti-PD1 therapies.
The combination of RP1 and Opdivo showed an objective response rate (ORR) of 33.6% as defined by modified RECIST v1.1 criteria, and an ORR of 32.9% by standard RECIST v1.1 criteria.
These results are significant considering that an ORR of 10% or less is typically expected with an anti-PD1 agent alone in this patient population. The median duration of response from the initiation of treatment was 27.6 months.
The data presented indicated that the response rate of RP1 plus Opdivo was consistent across all sub-groups analyzed in the trial, with the lowest ORR being 27.7%.
Additionally, the treatment demonstrated an abscopal effect, where non-injected lesions responded to the therapy. This suggests a systemic benefit from the localized treatment.
Survival rates for patients treated with RP1 and Opdivo were also encouraging, with one-, two-, and three-year survival rates reported at 75.3%, 63.3%, and 54.8%, respectively.
The safety profile for RP1 plus Opdivo was considered relatively benign, with only 12.8% of patients experiencing Grade 3 or higher treatment-related adverse events (TRAEs). The most severe adverse event reported was fatigue, affecting a mere 0.7% of patients.
H.C. Wainwright compared these findings to Amtagvi (lifileucel), an autologous tumor-infiltrating lymphocyte (TIL) therapy, which showed a 31.4% ORR and a median duration of response of 36.5 months, but with a significantly higher percentage of patients (94.9%) experiencing severe treatment-emergent adverse events (TEAEs).
In other recent news, Replimune Group has made significant strides in the development of its melanoma treatment candidate, RP1. Following a successful pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA), the company is on track to submit a BLA for RP1 in the second half of 2024.
This development has led to reiterated Buy ratings and a $17.00 price target on Replimune's stock from BMO Capital, H.C. Wainwright, and Roth/MKM.
Replimune is also progressing with its Phase 3 IGNYTE-3 trial of RP1, which focuses on melanoma patients unresponsive to existing therapies. The company is preparing for a presentation of IGNYTE data at the European Society for Medical Oncology (ESMO) conference, which may offer additional insights into RP1's potential use.
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