Philogen and Sun Pharmaceutical (Sun Pharma) have announced the filing of a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for Nidlegy, an investigational neoadjuvant therapy, for locally advanced, fully resectable melanoma.
Intended to be administered intralesionally for four weeks, Nidlegy aims to enhance the immune response against neoplastic lesions.
The submission is a significant milestone, marking the first MAA for Nidlegy in this treatment setting.
The application is supported by data from the Phase III PIVOTAL study (PHL19IL2TNF-02/15) and a Phase II clinical trial (PHL19IL2TNF-02/12).
The multicentre, global, comparator-controlled, randomised, parallel-group Phase III trial assessed the safety and efficacy of intratumoral doses of Nidlegy as a neoadjuvant treatment, followed by standard-of-care (SOC) treatment of surgery versus SOC alone.
It enrolled 256 subjects across 22 European clinical sites.
Nidlegy significantly reduced the relapse or death risk - a reduction of 41% versus control.
The median recurrence-free survival more than doubled, and distant metastasis-free survival also showed significant improvement.
Nidlegy’s safety profile was characterised by low-grade, local adverse events without any Grade 3 to 4 immune-related adverse events and no drug-related deaths recorded.
Nidlegy is a proprietary biopharmaceutical product from Philogen. The asset is being developed in partnership with Sun Pharma for skin cancer treatment in Europe, New Zealand and Australia.
Sun Pharma Western Europe and ANZ business head Hellen De Kloet stated: “The filing of Nidlegy in Europe for its first indication marks an important milestone in our efforts to address a high unmet clinical need to help patients suffering from locally advanced, fully resectable melanoma.
“Once approved, Nidlegy’s novel mechanism has the potential to change the treatment paradigm in this life-threatening disease in a neoadjuvant setting. We are excited at the prospect of bringing this important product to the benefit of physicians and patients.”
Earlier in 2024, Sun Pharma signed a definitive merger agreement to acquire Taro Pharmaceutical shares not currently owned by the company or its affiliates for $347.73m in cash.
