Replimune Submits BLA for RP1 Melanoma Treatment, Gains FDA Breakthrough Therapy Designation

Key Insights

• Replimune has submitted a Biologics License Application (BLA) to the FDA for RP1 in combination with nivolumab to treat advanced melanoma patients who have progressed on anti-PD-1 therapy.
• The FDA granted Breakthrough Therapy designation to RP1, potentially accelerating its development and review for this patient population with limited treatment options.
• The BLA submission is based on data from the IGNYTE trial, with a confirmatory Phase 3 trial (IGNYTE-3) currently enrolling patients to support full approval.

Replimune Group, Inc. has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD-1 containing regimen. The FDA has granted Breakthrough Therapy designation to this combination, potentially expediting its development and review. The submission was made under the Accelerated Approval pathway, based on safety and clinical activity data from the IGNYTE clinical trial.

Breakthrough Therapy Designation

The Breakthrough Therapy designation is intended to expedite the development and review of therapies for serious diseases where preliminary clinical evidence indicates that the therapy may provide substantial improvement over existing available therapies on one or more clinically significant endpoints. This designation is based on the safety and clinical activity observed in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial.

Clinical Data and Ongoing Trial

The BLA is supported by data from the IGNYTE clinical trial. A confirmatory Phase 3 IGNYTE-3 trial of RP1 in combination with nivolumab in advanced melanoma patients who have progressed on anti-PD-1 and anti-CTLA-4 therapy, or who are not candidates for anti-CTLA-4 treatment, is currently enrolling patients.

RP1: Oncolytic Immunotherapy

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.

Executive Commentary

"Today is an important milestone for Replimune and for the melanoma community as we are one step closer to having another potential treatment available for patients who have limited options after progressing on anti-PD1 containing regimens," said Sushil Patel, Ph.D., CEO of Replimune.