Nidlegy™ Phase III PIVOTAL trial meets the study’s primary objective demonstrating statistically significant and clinically meaningful improvement in Recurrence-Free Survival for patients with locally advanced fully resectable melanoma
The study compared neoadjuvant intratumoral Nidlegy™ (Daromun) followed by surgery (treatment arm) vs. surgery alone (control arm).
- The study compared neoadjuvant intratumoral Nidlegy™ (Daromun) followed by surgery (treatment arm) vs. surgery alone (control arm).
- According to the protocol, the primary endpoint of the study was the Recurrence-Free Survival (RFS) assessed per Blinded Independent Central Review (BICR) for patients treated with Nidlegy™, compared to the control arm.
- At median follow-up of 27.6 months in both groups, the study met its primary endpoint with a statistically significant and clinically meaningful improvement in RFS of the treatment arm compared to the control arm.
- Prof. Dario Neri, co-founder, CEO and CSO of Philogen, commented: "We are extremely pleased to announce positive topline data emerging from our PIVOTAL program in locally advanced resectable melanoma.