Philogen S.p.A. and Sun Pharma on Monday announced the positive results from the Phase III PIVOTAL trial in patients with locally advanced fully resectable melanoma (NCT02938299).
According to a press statement, 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.
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, it stated.
Meanwhile, 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.
“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,” Prof. Dario Neri, co-founder, CEO and CSO of Philogen, said in a statement.
On May 30, 2023, Philogen and Sun Pharma entered into a distribution, license, and supply agreement for commercializing Nidlegy in Europe, Australia and New Zealand for the treatment of skin cancers.
“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,” Hellen De Kloet, Business Head – Western Europe and ANZ, Sun Pharma, said on Monday.
