Nidlegy marketing application submitted to EMA

Italy’s Philogen (BIT: PHIL) and Indian drugmaker Sun Pharmaceutical Industries (BSE: 524715) have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy (daromun), an investigational treatment for neoadjuvant (ie, prior to surgery) locally-advanced fully resectable melanoma.

The completed submission was based on clinical data from the Phase III PIVOTAL study (PHL19IL2TNF-02/15), whose primary results were presented at ASCO 2024, and on the Phase II trial (PHL19IL2TNF-02/12). If approved, Nidlegy – which Sun Pharma licensed from Philogen in 2023 - would become the first immunocytokine product to gain marketing authorization, according to the companies.

In the PIVOTAL trial, Nidlegy reduced the risk of relapse or death by 41% compared the control arm [HR 0.59; 95% CI 0.41-0.86; log-rank p=0.005]. Median Recurrence Free Survival was more than doubled. Distant metastasis-free survival (DMFS) was significantly improved, with a HR of 0.60 [0.37-0.95; p=0.029] between the two arms. The safety profile of Nidlegy was characterized mostly by low-grade, local adverse events (12.7% grade 3 TEAEs). No Grade 3-4 immune-related Adverse Events and no drug-related death recorded.