Shots:
- FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg or RP1) + nivolumab for adults with unresectable advanced cutaneous melanoma whose disease progressed on an anti-PD-1 antibody-based regimen
- P-II (IGNYTE) trial enrolled 140 pts, with 91 efficacy-evaluable pts having ≥1 non-injected lesion. Tudriqev + nivolumab achieved a 24.2% ORR & an mDoR of 14.1mos., with results published in the JCO
- Tudriqev is administered via direct intratumoral injection into superficial, deep, and/or visceral lesions. Its clinical benefit is being confirmed in the ongoing P-III (IGNYTE-3) trial evaluating Tudriqev + nivolumab
Ref: Businesswire | Image: Replimune | Press Release
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