Philogen resubmits EMA marketing application for Nidlegy with updated Phase III melanoma data

According to the company, the PIVOTAL study demonstrated that Nidlegy reduced the risk of relapse or death compared with the control arm

Italian biotechnology company Philogen S.p.A. has resubmitted an updated Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for Nidlegy™, its investigational immunotherapy for the neoadjuvant treatment of adult patients with locally advanced, fully resectable melanoma.

The updated application is supported by longer-term clinical data from the Phase III PIVOTAL study (PH-L19IL2TNF-02/15), extending the median patient follow-up to 33 months from 21 months included in the original June 2024 submission. 

The revised dossier also incorporates additional post-hoc analyses focused on event-free survival, along with expanded Chemistry, Manufacturing and Controls (CMC) information aimed at addressing issues raised during the previous regulatory review.

According to the company, the PIVOTAL study demonstrated that Nidlegy reduced the risk of relapse or death compared with the control arm, while maintaining a favourable safety profile characterised primarily by low-grade, local adverse events.

The submission is further supported by efficacy and safety data from the Phase II PH-L19IL2TNF-02/12 study, safety findings from the ongoing Phase III NeoDREAM melanoma trial, and data from a Phase II study evaluating the therapy in non-melanoma skin cancer.

"Nidlegy remains a key priority in our oncology pipeline," said Prof. Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer, Philogen. 

He further added, “Since the previous MAA procedure, our team has worked intensively to address both the clinical and CMC questions raised during the review. At the same time, we have expanded the global Phase III NeoDREAM melanoma study and initiated additional registrational studies in non-melanoma skin cancers.”

Philogen has partnered with Sun Pharmaceutical Industries for the commercialisation of Nidlegy in skin cancer indications across Europe, Australia and New Zealand, positioning the therapy for potential market entry pending regulatory approval.