Philogen Resubmits Nidlegy Marketing Application to EMA with Extended Phase III Melanoma Data
Key Insights
Philogen (search) has resubmitted an updated Marketing Authorization Application to the EMA for Nidlegy in locally advanced, fully resectable melanoma (search).
The updated dossier includes extended median follow-up data of 33 months from the pivotal Phase III PIVOTAL study, up from 21 months in the prior submission.
Nidlegy demonstrated a 41% lower risk of relapse or death compared with surgery alone, with a favorable safety profile of primarily low-grade local adverse events.
Philogen (search) S.p.A., an Italian biotechnology company, has resubmitted an updated Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Nidlegy (daromun), its investigational targeted immunotherapy for the neoadjuvant treatment of adult patients with locally advanced, fully resectable melanoma (search). The resubmission marks a significant step forward for a therapy that has shown meaningful clinical benefit in a setting with limited treatment options.
The updated dossier incorporates substantially longer patient follow-up from the pivotal Phase III PIVOTAL study (PH-L19IL2TNF-02/15), extending the median follow-up to 33 months compared with 21 months in the original June 2024 submission. The revised application also includes additional post-hoc analyses focused on event-free survival, along with expanded Chemistry, Manufacturing and Controls (CMC) information intended to address outstanding questions raised during the previous regulatory review.
Clinical Evidence and Mechanism of Action
Nidlegy is a targeted immunotherapy comprising two active ingredients — L19IL2 and L19TNF. The L19 antibody binds to the Extra Domain B of Fibronectin (search), a protein expressed in tumors but absent in most healthy tissues, and delivers two pro-inflammatory cytokines — IL-2 and TNF (search) — directly to the tumor site. This dual-cytokine approach is designed to disrupt tumor cell growth and trigger a localized immune response.
In the PIVOTAL study, patients treated with Nidlegy following surgery demonstrated a 41% lower risk of relapse or death compared with those who underwent surgery alone. The safety profile was characterized primarily by low-grade, local adverse events, according to the company.
The submission is further supported by efficacy and safety data from the Phase II PH-L19IL2TNF-02/12 study, safety findings from the ongoing Phase III NeoDREAM melanoma (search) trial, and data from a Phase II study evaluating the therapy in non-melanoma skin cancers.
Expanding Beyond Melanoma (search)
Philogen (search) is also advancing Nidlegy in non-melanoma (search) skin cancer indications. According to Phase II Duncan study topline results presented at the European Society for Medical Oncology (ESMO) in 2025, the drug reported complete pathological responses in 52.6% of patients with basal cell carcinoma (search) (BCC) and cutaneous squamous cell carcinoma (search) (cSCC). The company has launched additional registrational studies in these non-melanoma skin cancers.
"Nidlegy remains a key priority in our oncology pipeline," said Prof. Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen (search). "Since the previous MAA procedure, our team has worked intensively to address both the clinical and CMC questions raised during the review. At the same time, we have expanded the global Phase III NeoDREAM melanoma (search) study and initiated additional registrational studies in non-melanoma skin cancers."
Commercialization Framework
Sun Pharmaceutical Industries holds exclusive rights to commercialize Nidlegy across Europe, Australia, and New Zealand under a licensing agreement announced in 2023. Under the terms, the two companies will share post-commercialization profits on a 50:50 basis. Philogen (search) retains responsibility for clinical development, regulatory filings, and manufacturing, as well as intellectual property ownership and the option to explore the drug for indications beyond skin cancers. Financial terms of the licensing agreement were not disclosed.
The EMA will now review the updated dossier, with a decision anticipated following the regulatory assessment process.