Victor Moreno։ FDA Approves RP1 Plus Nivolumab for PD-1-Refractory Melanoma

Victor Moreno, Director Clinical Research at START Madrid FJD, shared on LinkedIn:

“Oncolytic immunotherapy has reached a major milestone.

RP1 plus nivolumab is now FDA-approved for PD-1-refractory melanoma, with durable responses seen beyond the injected lesions.

The accelerated approval is based on the single-arm IGNYTE study. Among 91 patients with at least one non-injected lesion, ORR was 24.2% and median response duration was 14.1 months.

These are encouraging results, although a single-arm combination trial cannot fully determine the contribution of each drug.

The ongoing randomized trial will be essential to confirm the benefit.”

FDA: FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma.”

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