Marketing Authorization Application (MAA) for melanoma therapy Nidlegy™ has been submitted to the European Medicines Agency (EMA) by Philogen S.p.A. and Sun Pharmaceutical Industries Limited, along with their subsidiaries and associated companies. This submission is grounded on clinical data from the Phase 3 PIVOTAL study (PHL19IL2TNF-02/15), which presented its primary results at ASCO 2024, and from the Phase 2 trial (PHL19IL2TNF-02/12). If approved, Nidlegy™ will be the first immunocytokine product to receive marketing authorization.
Nidlegy™ is administered intralesionally over four weeks and works by enhancing the immune response against neoplastic lesions. The Phase 3 PIVOTAL trial randomized 256 patients in a 1:1 ratio to either the treatment arm (neoadjuvant Nidlegy™ followed by surgery) or the control arm (surgery alone). Over 90% of these patients had previously undergone treatments including surgery, systemic therapy, or radiotherapy, and a substantial portion had in-transit or satellite metastases, indicating a worse prognosis compared to treatment-naïve patients.
In this trial, patients receiving Nidlegy™ showed a 41% reduction in the risk of relapse or death compared to the control arm [HR 0.59; 95% CI 0.41-0.86; log-rank p=0.005]. The median recurrence-free survival was more than doubled, and distant metastasis-free survival (DMFS) significantly improved with a hazard ratio of 0.60 [0.37-0.95; p=0.029]. The safety profile of Nidlegy™ was predominantly characterized by low-grade local adverse events, with 12.7% of patients experiencing grade 3 treatment-emergent adverse events (TEAEs). Importantly, there were no grade 3-4 immune-related adverse events or drug-related deaths.
Philogen and Sun Pharma Highlight Potential of Nidlegy™ to Transform Melanoma Treatment
Dario Neri, CEO, and Chief Scientific Officer at Philogen, expressed enthusiasm about the potential impact of Nidlegy™: “We are excited about the opportunity to introduce an innovative and well-tolerated immunotherapy to patients with locally advanced, fully resectable melanoma in Europe. This collaboration with Sun Pharma leverages our joint strengths to bring meaningful advances to patient care.”
Hellen De Kloet, Business Head for Western Europe and ANZ at Sun Pharma, also highlighted the significance of this milestone: “The filing of Nidlegy™ in Europe for its first indication is a major step in addressing the high unmet clinical needs of patients with locally advanced, fully resectable melanoma. Once approved, Nidlegy™’s novel mechanism has the potential to transform the treatment paradigm in this critical neoadjuvant setting.”
Nidlegy™ combines two active ingredients, L19IL2 and L19TNF, which are mixed prior to intralesional administration. The L19 antibody targets the Extra Domain B of Fibronectin, a protein expressed in tumors but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with potent anti-tumor activities. Currently, Nidlegy™ is being investigated in two Phase III clinical trials for locally advanced melanoma and Phase II trials for high-risk basal cell carcinoma and other non-melanoma skin cancers.
Phase 3 Study Validates Nidlegy™ for Treating Locally Advanced Melanoma
The Phase 3 PIVOTAL study, an international multi-center trial, evaluated the efficacy and safety of Nidlegy™ as a neoadjuvant treatment. The trial enrolled 256 patients across 22 clinical centers in Germany, Italy, France, and Poland. Patients received Nidlegy™ injections up to four times, once a week, before undergoing standard-of-care surgery. Adjuvant treatment with approved drugs was permitted for both study arms.
Locally advanced melanoma is characterized by the spread of neoplastic lesions to regional lymph nodes, presenting as micrometastases, satellite/in-transit metastases, and/or lymph node metastases. Currently, patients with resectable disease undergo surgery, potentially followed by systemic adjuvant therapies. However, no approved drugs exist for treating locally advanced, fully resectable melanoma in the neoadjuvant setting.
This MAA submission represents a significant advancement in the treatment of melanoma. Nidlegy™, if approved, promises to offer a new, effective, and well-tolerated option for patients with locally advanced melanoma, potentially improving their prognosis and quality of life. Philogen and Sun Pharma’s collaboration underscores their commitment to addressing unmet medical needs and enhancing patient care through innovative therapeutic solutions.
Resource: Sun Pharma, June 04, 2024
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