Sun Pharma, Philogen seek EMA marketing nod for skin cancer treatment Nidlegy

The completed submission was based on clinical data from the Phase 3 PIVOTAL study (PHL19IL2TNF-02/15), whose primary results were presented at ASCO 2024, and on the Phase 2 trial (PHL19IL2TNF-02/12).

If approved, Nidlegy would become the first immunocytokine product to gain marketing authorization, according to the release.

Nidlegy is given intralesionally for 4 weeks and acts by boosting the immune system against neoplastic lesions.

In the PIVOTAL trial, a total of 256 patients were randomized 1:1 to the treatment (neoadjuvant Nidlegy followed by surgery) and to the control arm (surgery). More than 90% 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% of patients received post-surgery adjuvants in the control arm, compared to 29.8% in the treatment arm. In the PIVOTAL trial, Nidlegy reduced the risk of relapse or death by 41% compared the control arm [HR 0.59; 95% 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 characterized mostly by low-grade, local adverse events (12.7% grade 3 TEAEs). No Grade 3-4 immune-related Adverse Events and no drug-related death recorded.