Philogen and Sun Pharmaceutical Industries announce 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 per cent (HR = 0.67) and 37 per cent (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 per cent 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 clinica l 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.
Philogen and Sun Pharma announced on May 30, 2023, to have entered into distribution, license and supply agreement for commercialising Nidlegy in Europe, Australia and New Zealand for the treatment of skin cancers.