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Replimune's RP1 Receives FDA Breakthrough Therapy Designation and BLA Submission for Advanced Melanoma

• Replimune has submitted a Biologics License Application (BLA) to the FDA for RP1 in combination with nivolumab to treat advanced melanoma patients after anti-PD-1 therapy. • The FDA granted Breakthrough Therapy designation to RP1 plus nivolumab, expediting its development for patients with limited options after anti-PD-1 regimen failure. • RP1 (vusolimogene oderparepvec) is an oncolytic immunotherapy designed to maximize tumor killing, enhance immunogenicity, and activate a systemic anti-tumor immune response. • A Phase 3 trial is underway to confirm RP1's efficacy with nivolumab in advanced melanoma patients who have progressed on or are ineligible for anti-CTLA-4 therapy.

Replimune Group, Inc. has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its oncolytic immunotherapy, RP1 (vusolimogene oderparepvec), in combination with nivolumab. This therapeutic approach targets adult patients with advanced melanoma who have previously progressed on an anti-PD-1 containing regimen. The FDA has also granted RP1 Breakthrough Therapy designation for the same indication, potentially accelerating its development and review.
The Breakthrough Therapy designation is reserved for therapies demonstrating substantial improvement over existing options for serious conditions based on preliminary clinical evidence. Replimune's application is supported by safety and clinical activity data from the anti-PD-1 failed melanoma cohort of the IGNYTE clinical trial.
According to Sushil Patel, Ph.D., CEO of Replimune, this marks a significant step toward providing a new treatment option for melanoma patients with limited alternatives after progressing on anti-PD-1 therapies.

RP1: Oncolytic Immunotherapy

RP1 (vusolimogene oderparepvec) is Replimune’s leading candidate, engineered from a proprietary strain of herpes simplex virus. It is genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor cell death, enhance the immunogenicity of cell death, and stimulate a systemic anti-tumor immune response.

Ongoing Phase 3 Trial

The confirmatory Phase 3 IGNYTE-3 trial is currently enrolling patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapy or are ineligible for anti-CTLA-4 treatment. This trial aims to further evaluate the efficacy and safety of RP1 in combination with nivolumab.
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FDA Reviewing RP1 and Nivolumab Combination for Advanced Melanoma After PD-1 Inhibitor Failure

The FDA is evaluating a biologics license application for RP1 plus nivolumab to treat advanced melanoma in adults who have previously received a PD-1 inhibitor.
The application is supported by data from the phase 1/2 IGNYTE trial, which demonstrated an overall response rate of 32.7% in patients with anti-PD-1-failed melanoma.

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FDA Grants Breakthrough Therapy Designation to RP1 Plus Nivolumab for Advanced Melanoma

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A Biologics License Application (BLA) has been submitted for RP1 with nivolumab under the Accelerated Approval pathway for previously treated advanced melanoma.

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Replimune's RP1 Receives FDA Breakthrough Therapy Designation for Advanced Melanoma

Replimune's RP1, combined with nivolumab, has been granted Breakthrough Therapy designation by the FDA for advanced melanoma after anti-PD-1 treatment failure.
The BLA submission to the FDA for RP1 in combination with nivolumab was made under the Accelerated Approval pathway.

Replimune's RP1 Receives FDA Breakthrough Therapy Designation for Advanced Melanoma

Replimune's RP1 (vusolimogene oderparepvec) has been granted Breakthrough Therapy designation by the FDA for advanced melanoma treatment.
The BLA for RP1 in combination with nivolumab has been submitted to the FDA under the Accelerated Approval pathway.

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

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.

Replimune's RP1 Receives Positive FDA Feedback for Melanoma Treatment

Replimune completed a successful pre-BLA meeting with the FDA for RP1 in anti-PD1 failed melanoma, supporting an accelerated approval pathway.
The IGNYTE clinical trial showed a 33% overall response rate when RP1 was combined with nivolumab in patients with advanced melanoma.

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Reference News

[1]
Replimune Receives Breakthrough Therapy Designation for RP1 and Submits ... - Pipelinereview
pipelinereview.com · Nov 24, 2024

Replimune submitted a BLA to the FDA for RP1 in combination with nivolumab for advanced melanoma patients who have previ...

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