Italian-Swiss biotechnology company Philogen and Sun Pharmaceutical announced positive results from the Phase III “Pivotal” trial of Nidlegy on locally advanced melanoma.

Nidlegy is Philogen’s prorpietary product to treat skin cancer and is being investigated for the treatment of locally advanced melanoma, and for the treatment of high-risk basal cell carcinoma and other non-melanoma skin cancers. In May, Philogen and Sun Pharma had entered into a distribution, licence and supply agreement for commercializing Nidlegy in Europe, Australia and New Zealand for the treatment of skin cancers.  

The pivotal trial compared the treatment arm of patients on Nidlegy (Daromun) followed by surgery versus the control arm of patients undergoing only surgery. Patients were allowed to receive the approved adjuvant systemic therapies after surgery in both arms, a note Sun Pharma said.

Trial end-point

According to the protocol, the primary endpoint of the study was the recurrence-free survival (RFS) assessed in the 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,” the note added.

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.

The Pivotal study 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, the note said.

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, it said, adding that 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, the companies said.

Dario Neri, co-founder, CEO and CSO of Philogen said, 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, the CEO added.

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