On January 13, 2021 Philogen S.p.A., a clinical-stage biotechnology company focused on antibody-based therapeutics, reported that 50% of the expected events for the primary outcome analysis of the PIVOTAL study were reached in December 2020 (Press release, Philogen, JAN 13, 2021, View Source [SID1234573982]). 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. On Dec. 22, 2020, the DSMB met to review the data and issued to the company a recommendation to continue with the study and patient accrual as detailed by the clinical protocol.
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PIVOTAL is a phase III, international, multi-center, randomized, comparator-controlled, parallel-group study evaluating the efficacy and safety of intratumoral injections of Nidlegy as a neoadjuvant, followed by standard-of-care treatment (surgery + approved adjuvants), as opposed to standard-of-care treatment alone, in melanoma patients with locally advanced, fully resectable cutaneous, sub-cutaneous, or nodal metastases, accessible to intratumoral injection. A first interim analysis at 25% of the expected events and 82 enrolled patients had already been carried out in March 2019.
The primary endpoint of the trial comprises the assessment of Recurrence-Free Survival at one year after randomization. Secondary endpoints include Overall Survival, Local Recurrence-Free Survival and Distant Metastasis-Free Survival, as well as Safety.
The study is expected to include 214 patients across more than 20 centers (currently 18 centers) in four different EU countries (France, Germany, Italy, Poland).
Dario Neri, Chief Executive Officer of Philogen, commented, "We are extremely pleased to record the PIVOTAL study DSMB’s recommendation to carry on with the study as originally planned. This reinforces the confidence in our strategy to bring Nidlegy to the market as a new therapeutic opportunity for melanoma patients."