Philogen Announces the Completion of a Second Interim Analysis of Its Phase III Clinical Program With Nidlegy for the Treatment of Melanoma

Source: PR Newswire, January 2021

hilogen S.p.A., a clinical-stage biotechnology company focused on antibody-based therapeutics, is pleased to announce that 50% of the expected events for the primary outcome analysis of the PIVOTAL study were reached in December 2020.

In this phase III clinical trial, the effect of Nidlegy™ is evaluated in melanoma patients with locally advanced, fully resectable metastatic cancer, and at the time of the second interim analysis, had already recruited 149 out of the anticipated 214 patients (one additional patient was enrolled recently).

As a consequence, the second interim data analysis foreseen by the clinical protocol was carried out and submitted to the Data and Safety Monitoring Board of the study for their consideration.