(Alliance News) - Philogen Spa and Sun Pharmaceutical Industries Ltd on Monday announced positive results from the Phase III Pivotal study in patients with fully resectable locally advanced melanoma.

The study compared neoadjuvant Nidlegy (Daromun) administered intratumorally before surgery versus surgery alone. Patients could receive approved adjuvant systemic therapies after surgery in both arms of the study.

According to the protocol, the primary objective of the study was Recurrence Free Survival assessed in a blinded manner by an independent committee for patients treated with Nidlegy compared to the control arm. With a median patient observation time of 27.6 months considering both groups, the study positively met the primary objective, statistically and clinically significantly improving the RFS of the treatment arm compared with the control arm.

This positive result is in line with the review performed by the investigating physicians: a significant reduction in the risk of recurrence or death by 33% and 37%, respectively, in favor of the treatment arm was observed in both the BICR analysis and the investigators' evaluation.

Dario Neri, co-founder, CEO and CSO of Philogen, commented, "We are extremely pleased to announce the positive results that have emerged from our Pivotal study in locally advanced resectable melanoma. The clinical data in melanoma and high-risk non-melanoma skin cancers bode well for the possible adoption of Nidlegy administered intralesionally in a variety of dermato-oncologic indications. Philogen is currently conducting six other advanced clinical trials with registration potential, which include Nidlegy and Fibromun as active ingredient candidates, which are the company's most advanced stage investigational products."

Philogen's stock is up 1.1 percent at EUR18.65 per share.

By Giuseppe Fabio Ciccomascolo, Alliance News senior reporter

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