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.

"We are enthusiastic about the possibility to bring an innovative and well-tolerated immunotherapy to patients with locally advanced, fully resectable melanoma in Europe by leveraging Philogen’s strong collaboration with Sun Pharma," commented Dario Neri, chief executive officer and chief scientific officer at Philogen.

"This disease is currently managed with surgery, potentially followed by systemic adjuvant therapies that are potentially given for years. Having access to a short, well tolerated, and fast acting therapeutic intervention like Nidlegy represents a major advance for patients."

Hellen De Kloet, Business Head - Western Europe and ANZ, Sun Pharma, said “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.”

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.