Philogen S.p. A. and Sun Pharma Industries Limited announced positive results from the Phase III PIVOTAL trial in patients with locally advanced fully resectable melanoma (NCT02938299). The study compared neoadjuvant intratumoral Nidlegy (Daromun) followed by surgery (treatment arm) vs. surgery alone (control arm).

Patients were allowed to receive approved adjuvant systemic therapies after surgery in both arms. 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 observedboth 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.

Nidlegy? is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF which are manufactured independently, and which are mixed prior to intralesional administration.

The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) andTumor Necrosis Factor (TNF) are pro-inflammatory cytokines with anti-tumor activity. Nidlegy?

is currently being investigated in two Phase III clinical trials for the treatment of locally advanced melanoma, and in Phase II clinical trials for the treatment of High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.