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Sun Pharma, Philogen seek EMA marketing nod for skin cancer treatment Nidlegy

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-06-04T16:45:26+05:30  |  Updated On 4 Jun 2024 4:45 PM IST
Court Removes Injunction on Sun Pharmas LEQSELVI Launch in US

Sun Pharma

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Mumbai: Philogen S.p.A. and Sun Pharmaceutical Industries Limited have announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy, an investigational treatment for neoadjuvant (i.e., prior to surgery) locally advanced fully resectable melanoma.

The completed submission was based on clinical data from the Phase 3 PIVOTAL study (PHL19IL2TNF-02/15), whose primary results were presented at ASCO 2024, and on the Phase 2 trial (PHL19IL2TNF-02/12).
If approved, Nidlegy would become the first immunocytokine product to gain marketing authorization, according to the release.
Nidlegy is given intralesionally for 4 weeks and acts by boosting the immune system against neoplastic lesions.
In the PIVOTAL trial, a total of 256 patients were randomized 1:1 to the treatment (neoadjuvant Nidlegy followed by surgery) and to the control arm (surgery). More than 90% of the enrolled patients had received previous treatments, including surgery, systemic therapy or radiotherapy. A consistent aliquot of the enrolled subjects presented with in-transit or satellite metastases. These patients, although still resectable and with a locally advanced disease, have a worse prognosis compared to naïve locally advanced patients, who have often been the backbone of patient populations included in registration studies with systemic immune- or targeted therapies in the adjuvant and neoadjuvant settings. The study allowed for post-surgery adjuvant therapies. 40.5% of patients received post-surgery adjuvants in the control arm, compared to 29.8% in the treatment arm. In the PIVOTAL trial, Nidlegy reduced the risk of relapse or death by 41% compared the control arm [HR 0.59; 95% CI 0.41-0.86; log-rank p=0.005]. Median Recurrence Free Survival was more than doubled. Distant metastasis-free survival (DMFS) was significantly improved, with a HR of 0.60 [0.37-0.95; p=0.029] between the two arms. The safety profile of Nidlegy was characterized mostly by low-grade, local adverse events (12.7% grade 3 TEAEs). No Grade 3-4 immune-related Adverse Events and no drug-related death recorded.
"We are enthusiastic about the possibility to bring an innovative and well-tolerated immunotherapy to patients with locally advanced, fully resectable melanoma in Europe by leveraging Philogen’s strong collaboration with Sun Pharma," commented Dario Neri, chief executive officer and chief scientific officer at Philogen.
"This disease is currently managed with surgery, potentially followed by systemic adjuvant therapies that are potentially given for years. Having access to a short, well tolerated, and fast acting therapeutic intervention like Nidlegy represents a major advance for patients."
Hellen De Kloet, Business Head - Western Europe and ANZ, Sun Pharma, said “The filing of Nidlegy in Europe for its first indication marks an important milestone in our efforts to address a high unmet clinical need to help patients suffering from locally advanced, fully resectable melanoma. Once approved, Nidlegy’s novel mechanism has the potential to change the treatment paradigm in this life-threatening disease in a neoadjuvant setting. We are excited at the prospect of bringing this important product to the benefit of physicians and patients.”
Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia. Both companies jointly announced on October 23, 2023, that the Phase 3 PIVOTAL trial met the primary endpoint of recurrence-free survival.

Read also: Sun Pharma anticipates high single-digit top line growth in current fiscal: Dilip Shanghvi

philogensun pharmasun pharma newsnidlegyresectable melanoma
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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