Philogen Announces the Completion of a Second Interim Analysis of Its Phase III Clinical Program With Nidlegy for the Treatment of Melanoma
Nidlegy was found to be well-tolerated and 149 out of the anticipated 214 patients have been safely treated. Data Safety Monitoring Board recommends to continue the study as planned.
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SIENA, Italy, Jan. 13, 2021 /PRNewswire/ Philogen 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 sec