Sun Pharma announces positive Phase III results for Nidlegy in locally advanced fully resectable melanoma patients

According to the protocol, the primary endpoint of the study was the Recurrence-Free Survival (RFS) assessed per Blinded Independent Central Review (BICR) for patients treated with Nidlegy, compared to the control arm. At median follow-up of 27.6 months in both groups, the study met its primary endpoint with a statistically significant and clinically meaningful improvement in RFS of the treatment arm compared to the control arm. This positive outcome was consistently in line with the Investigators’ Assessment: a significant reduction of the hazard risk ratio of 33% (HR = 0.67) and 37% (HR = 0.63), respectively, favoring the treatment arm, was observed both in the BICR and in the Investigators’ Assessment analysis.

Treatment-related adverse events observed with Nidlegy were benign and manageable, consistent with the proposed mechanism of action and with the favorable safety profile previously reported in the Phase II study [Danielli et al. (2015) Cancer Immunol. Immunother., 64, 999]. Grade 3 adverse events occurred in 24.8% of the treated patients. Neither grade 4 toxicity nor treatment-related deaths were observed in the study. Nidlegy treatment was not associated with the induction of autoimmune conditions.

PIVOTAL enrolled 257 patients in Europe across 22 clinical centers in Germany, Italy, France and Poland. The results, including sub-group analyses, will be presented at a forthcoming medical meeting.

Nidlegy is also being developed in dedicated Phase II clinical trials for the treatment of aggressive forms of non-melanoma skin cancer, including high-risk locally advanced basal cell carcinoma and cutaneous squamous cell carcinoma.

Prof. Dario Neri, co-founder, CEO and CSO of Philogen, commented, "We are extremely pleased to announce positive topline data emerging from our PIVOTAL program in locally advanced resectable melanoma. The clinical data in melanoma and high-risk non melanoma skin cancers bode well for the possible adoption of intralesional Nidlegy in a series of Dermato-Oncology indications. Philogen is currently executing six additional advanced clinical trials with registration potential featuring either Nidlegy or Fibromun, the company’s most advanced product candidates, as active ingredients.”

Alfredo Covelli, MD, Chief Medical Officer of Philogen, commented, "Neoadjuvant cytokine therapy for the treatment of locally advanced skin cancers enables a robust expansion of tumor-infiltrating lymphocytes. By anchoring interleukin-2 and tumor necrosis factor within the tumor mass through the L19 antibody moiety, we minimize systemic side effects while mounting a systemic robust anti-cancer immune response. This Phase 3 study merged the intralesional approach with IL2, pioneered by Prof. Claus Garbe more than 20 years ago, with the concepts of antibody-based tumor targeting, and with neoadjuvant therapy in locally advanced melanoma. The approach may find a broad applicability in different types of cancer.”

Hellen De Kloet, Business Head - Western Europe and ANZ, Sun Pharma, said, "We are looking forward to commercializing Nidlegy in Europe, Australia and New Zealand as the first neoadjuvant immunotherapy for patients with resectable advanced melanoma. Nidlegy, as an intralesional therapeutic option, addresses the existing significant unmet need for effective and well-tolerated treatments in patients, before undergoing surgery”.

Philogen and Sun Pharma announced on May 30^th, 2023, to have entered into distribution, license and supply agreement for commercializing Nidlegy in Europe, Australia and New Zealand for the treatment of skin cancers.