Philogen and Sun Pharmaceutical (Sun Pharma) jointly announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for Nidlegy, an investigational neoadjuvant therapy designed for locally advanced, fully resectable melanoma.
Nidlegy is intended to be administered intralesionally for a duration of four weeks, aiming to bolster the immune response against neoplastic lesions. This submission marks a significant milestone as it represents the first MAA for Nidlegy in this particular treatment context.
Supporting evidence for the application draws from both the Phase III PIVOTAL study (PHL19IL2TNF-02/15) and a Phase II clinical trial (PHL19IL2TNF-02/12). The Phase III trial, conducted across multiple centers globally, employed a comparator-controlled, randomized, parallel-group design to evaluate the safety and efficacy of intratumoral doses of Nidlegy as a neoadjuvant treatment, followed by standard-of-care (SOC) surgery versus SOC alone. A total of 256 subjects were enrolled across 22 European clinical sites.
Results from the study demonstrated that Nidlegy significantly reduced the risk of relapse or death by 41% compared to the control group. Additionally, median recurrence-free survival more than doubled, and there was a notable improvement in distant metastasis-free survival.
The safety profile of Nidlegy was characterized by predominantly low-grade, local adverse events, with no Grade 3 to 4 immune-related adverse events reported and no drug-related fatalities recorded.
As reported by finance.yahoo.com, Nidlegy is a proprietary biopharmaceutical product developed by Philogen, and it is being co-developed with Sun Pharma for the treatment of skin cancer in Europe, New Zealand, and Australia.
