On July 27, 2026 Philogen S.p.A. (BIT:PHIL) reported the submission of an updated Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the approval of Nidlegy, an investigational product for the neoadjuvant treatment of adult patients with locally advanced, fully resectable melanoma.
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The updated submission is based on clinical data from the randomized Phase III PIVOTAL study (PHL19IL2TNF-02/15; NCT02938299). Compared with the MAA submitted in June 2024, the updated dossier is based on a longer median patient follow-up (33 months as opposed to 21 months) and includes additional posthoc analyses focused on event-free survival. Clinical data supporting the 2024 submission were published in Annals of Oncology (Kähler et al., Annals of Oncology, 2025, 36, 1166). The updated data forming the basis of this resubmission have been accepted for publication in the Journal of Clinical Oncology (doi 10.1200/JCO26-00852) and are expected to be published online in the coming weeks.
In the PIVOTAL study, Nidlegy reduced the risk of relapse or death compared with the control arm, and its safety profile was characterized mostly by low-grade, local adverse events. The updated application also includes additional Chemistry, Manufacturing and Controls (CMC) information intended to address the outstanding questions raised during the previous procedure.
Additional supporting data included in the dossier comprise efficacy and safety data from the Phase II study PH-L19IL2TNF-02/12 (NCT02076633), safety data from the ongoing Phase III NeoDREAM study PHL19IL2TNF-01/18 (NCT03567889), and safety data from the Phase II study PH-L19IL2TNFNMSC-04/19 (NCT04362722) in non-melanoma skin cancer.
Prof. Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen, commented: "Philogen remains fully committed to advancing Nidlegy in melanoma and non-melanoma skin cancers. Since the previous MAA procedure, our team has worked intensively to address the clinical and CMC questions raised during the review. In parallel, we have continued to expand the global Phase III NeoDREAM melanoma study and have launched additional registrational studies in non-melanoma skin cancers. We are encouraged by the data generated to date and will continue working with our partners and regulators with the aim of bringing this innovative treatment to patients in need."
Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia.
About Nidlegy (Daromun)
Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF. The two ingredients are manufactured independently and mixed prior to intralesional administration. The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with a potent anti-tumor activity. 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.
About the PIVOTAL Phase III study
PIVOTAL is a phase III, international, multi-center, randomized, comparator-controlled, parallel-group study evaluating the efficacy and safety of intratumoral injections of Nidlegy as a neoadjuvant treatment, followed by standard-of-care treatment (surgery), as opposed to standard-of-care treatment (i.e., surgery alone), in melanoma patients with locally advanced, fully resectable cutaneous, sub-cutaneous (including satellite/in transit metastases), or nodal metastases accessible to intratumoral injection. For both arms, adjuvant treatment with approved drugs was allowed. Nidlegy was injected intralesionally up to four times, once a week, before surgery. The trial enrolled 256 patients in Europe across 22 clinical centers in Germany, Italy, France and Poland.
About locally advanced fully resectable melanoma
Melanoma is a skin tumor which begins when melanocytes start growing without control. Melanocytes are found in the basal layer of the epidermis at the boundary with the next layer (the dermis). Locally advanced melanoma is a metastatic cancer in which neoplastic lesions have spread to drainage areas of regional lymph nodes and can appear as micrometastases, satellite/in transit metastases, and/or lymph node metastases. To date, patients with resectable disease receive surgery, possibly followed by approved adjuvant systemic therapies. There is no approved drug for the treatment of locally advanced fully resectable melanoma in the neoadjuvant setting.
(Press release, Philogen, JUL 27, 2026, View Source [SID1234669431])