The new drug successfully met the primary endpoint of the Phase III PIVOTAL study by demonstrating a statistically and clinically significant improvement in Recurrence-Free Survival in patients with fully resectable locally advanced melanoma. For the first time in the history of oncology research, neoadjuvant therapy demonstrated a statistically and clinically significant benefit.
by Robert Crowe
In a joint statement issued from Siena, Italy, and Mumbai, India, Philogen S.p.A. and Sun Pharmaceutical Industries Limited announced with the solemnity and enthusiasm of grand occasions the results of a major Phase III clinical trial, called PIVOTAL, which could revolutionise the treatment of locally advanced melanoma.
The drug NidlegyTM, developed by Philogen, has demonstrated unprecedented success in improving Recurrence-Free Survival in patients with fully resectable locally advanced melanoma. In this pioneering study, NidlegyTM was administered intratumorally prior to surgery, and the results were extraordinary. For the first time in the history of cancer research, neoadjuvant therapy demonstrated a statistically and clinically significant benefit.
In particular, treatment with NidlegyTM significantly reduced the risk of recurrence or death in patients, with a 33% reduction in the risk of recurrence and a 37% reduction in the risk of death. These positive results were confirmed by both an independent committee and the investigators.
A notable aspect of NidlegyTM’s success was the drug’s safety profile, with manageable adverse events consistent with the drug’s mechanism of action. Grade 3 adverse events occurred in only 24.8% of treated patients, with no grade 4 toxicities or treatment-related deaths.
These groundbreaking results will be presented in detail at an international medical congress and submitted to peer-reviewed scientific journals and regulatory authorities.
In addition, NidlegyTM is currently under development for the treatment of other forms of skin cancer, including locally advanced high-risk basal cell carcinoma. The distribution, licensing and supply agreement with Sun Pharmaceutical Industries Limited will enable the commercialisation of NidlegyTM in Europe, Australia and New Zealand, opening up new perspectives for skin cancer patients.
Prof. Dario Neri, CEO and CSO of Philogen, commented: ‘We are extremely pleased to announce the positive results from our PIVOTAL study in locally advanced resectable melanoma. The clinical data in melanoma and high-risk non-melanoma skin cancers bode well for the possible adoption of NidlegyTM administered intralesionally in a variety of dermato-oncology indications. Philogen is currently conducting 6 other advanced clinical trials with registration potential, which include NidlegyTM and Fibromun as active ingredient candidates, which are the Company’s most advanced investigational products.”
Alfredo Covelli, MD, Chief Medical Officer of Philogen, added: “This Phase III study combined the intralesional approach with IL2, first pioneered by Prof. Claus Garbe more than 20 years ago, with the concepts of antibody-based targeted cancer therapy and neoadjuvant therapy in locally advanced melanoma. The approach could find wide application in different types of cancer.”
Hellen De Kloet, Business Head – Western Europe and ANZ at Sun Pharma, said: “We look forward to marketing NidlegyTM in Europe, Australia and New Zealand, the first neoadjuvant immunotherapy for patients with resectable advanced melanoma. As an intralesional therapeutic option, NidlegyTM addresses the unmet medical need for effective and well-tolerated treatments in patients before they undergo surgery.”
This Phase III study, called PIVOTAL, represents a significant step in the fight against melanoma and could pave the way for new innovative therapies for skin cancer patients.
(Associated Medias) – All rights reserved