The European Medicines Agency (EMA) has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma.

Nidlegy is an investigational treatment for neoadjuvant (before surgical procedure) locally advanced fully resectable melanoma.

The application, submitted on 4 June 2024, is based on data from the Phase III PIVOTAL study and a Phase II trial.

The international, multicentre, randomised, comparator-controlled, parallel-group PIVOTAL trial assessed the efficacy and safety of Nidlegy as a neoadjuvant treatment in melanoma patients with locally advanced, fully resectable cutaneous, subcutaneous or nodal metastases accessible to intratumoural injection.

A total of 256 patients were enrolled across 22 clinical centres in Italy, Germany, France and Poland.

Results from the PIVOTAL trial showed that Nidlegy reduced the relapse or mortality risk by 41% versus the control arm, with a significant improvement in median recurrence-free survival and distant metastasis-free survival (DMFS).

Nidlegy’s safety profile was characterised by mostly low-grade, local adverse events.

No grade 3 or grade 4 immune-related adverse events or drug-related deaths were recorded.

Nidlegy is a biopharmaceutical product of Philogen, designed to treat skin cancer through intralesional administration of two active ingredients, L19IL2 and L19TNF.

These ingredients are pro-inflammatory cytokines with potent anti-tumour activity.

Nidlegy is also being investigated in additional Phase III trials for locally advanced melanoma and Phase II trials for high-risk basal cell carcinoma and other non-melanoma skin cancers.

Philogen CEO and chief scientific officer Dario Neri stated: “The validation of the dossier by the EMA represents the first important milestone for the MAA review process.”

“Our group is committed to working with EMA throughout the review process to make Nidlegy available to patients in need.”