Sun Pharma and Philogen Move Forward with Nidlegy™ Marketing Approval

On June 4, 2024, Sun Pharmaceutical Industries Ltd, along with Philogen S.p.A., announced that Nidlegy™, an investigational treatment for neoadjuvant melanoma, has had its Marketing Authorization Application (MAA) submitted to the European Medicines Agency (EMA). Based on data from the Phase 3 PIVOTAL study (PHL19IL2TNF-02/15) and Phase 2 trial (PHL19IL2TNF-02/12), the submission marks a significant milestone. If approved, Nidlegy™ would be the pioneering immunocytokine product to receive marketing authorisation. Nidlegy™ is a biopharmaceutical product proprietary to Philogen.

Nidlegy™ is administered intralesionally over a 4-week period, aiming to enhance the immune response against neoplastic lesions. In the PIVOTAL trial, 256 patients were randomly assigned to either receive neoadjuvant Nidlegy™ followed by surgery or undergo surgery alone, with over 90% of them having undergone prior treatments. Many enrolled patients had in-transit or satellite metastases, representing a subgroup with a poorer prognosis despite being resectable. This differs from the typical patient profile in registration studies for systemic immune- or targeted therapies in neoadjuvant and adjuvant settings.

The company stated that the study allowed for post-surgery adjuvant therapies. In the control arm, 40.5% of patients received post-surgery adjuvants, compared to 29.8% in the treatment arm.

In the PIVOTAL trial, Nidlegy™ demonstrated a 41% reduction in the risk of relapse or death compared to the control arm (HR 0.59; 95% CI 0.41-0.86; log-rank p=0.005). The median Recurrence-Free Survival more than doubled, and Distant Metastasis-Free Survival (DMFS) significantly improved, with an HR of 0.60 (0.37-0.95; p=0.029) between the two arms. Nidlegy’s safety profile primarily consisted of low-grade, local adverse events (12.7% grade 3 TEAEs), with no Grade 3-4 immune-related Adverse Events or drug-related deaths recorded.

Commenting on this, Dario Neri, chief executive officer and chief scientific officer at Philogen, said, “We are enthusiastic about the possibility of bringing innovative and well-tolerated immunotherapy to patients with locally advanced, fully resectable melanoma in Europe by leveraging Philogen’s strong collaboration with Sun Pharma. 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 of Western Europe and ANZ at Sun Pharma, stated, “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™ has collaborated with Sun Pharma to treat Skin Cancers in New Zealand, Australia, and Europe. On October 23, 2023, both companies announced that the Phase 3 PIVOTAL trial met the primary endpoint of recurrence-free survival.

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