Nidlegy Marketing Authorization Application Submitted to EMA

First marketing authorisation submission for Nidlegy for the treatment of locally advanced, fully  resectable melanoma in the neoadjuvant setting

Philogen and Sun Pharma, announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the approval of  Nidlegy, an investigational treatment for neoadjuvant (i.e., prior to surgery) locally advanced fully resectable  melanoma. The completed submission was based on clinical data from the Phase 3 PIVOTAL study (PH L19IL2TNF-02/15), whose primary results were presented at ASCO 2024, and on the Phase 2 trial (PH L19IL2TNF-02/12). If approved, Nidlegy would become the first immunocytokine product to gain  marketing authorisation. 

Nidlegy is given intralesionally for four weeks and acts by boosting the immune system against neoplastic lesions. 

In the PIVOTAL trial, a total of 256 patients were randomised 1:1 to the treatment (neoadjuvant Nidlegy followed by surgery) and to the control arm (surgery). More than 90 per cent of the enrolled patients had received  previous treatments, including surgery, systemic therapy or radiotherapy. A consistent aliquot of the enrolled  subjects presented with in-transit or satellite metastases. These patients, although still resectable and with a  locally advanced disease, have a worse prognosis compared to naïve locally advanced patients, who have often  been the backbone of patient populations included in registration studies with systemic immune- or targeted  therapies in the adjuvant and neoadjuvant settings.  

The study allowed for post-surgery adjuvant therapies. 40.5 per cent of patients received post-surgery adjuvants in  the control arm, compared to 29.8 in the treatment arm. 

According to the statement, in the PIVOTAL trial, Nidlegy reduced the risk of relapse or death by 41 per cent compared to the control arm [HR  0.59; 95 per cent 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 characterised mostly by low-grade, local adverse events  (12.7 per cent  grade 3 TEAEs). No Grade 3-4 immune-related Adverse Events and no drug-related death recorded. 

Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and  Australia. Both companies jointly announced on October 23, 2023, that the Phase 3 PIVOTAL trial met the  primary endpoint of recurrence-free survival.