On August 17, 2026 Philogen S.p.A. (BIT:PHIL) reported the publication in the Journal of Clinical Oncology (JCO) of updated efficacy and safety results from the randomized Phase III PIVOTAL study (PH-L19IL2TNF-02/15; NCT02938299), evaluating Nidlegy (Daromun; L19IL2/L19TNF) as a neoadjuvant treatment for patients with locally advanced, fully resectable melanoma.

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The article, entitled "Neoadjuvant Intralesional Daromun (L19IL2/L19TNF) in Resectable Locally Advanced Melanoma: An Update on the Efficacy and Safety Results of the PIVOTAL Phase III Trial", was published online in the Journal of Clinical Oncology on 11 August 2026 (Vol. 44, Issue 23; doi: 10.1200/JCO-26-00852).

The JCO publication represents an updated analysis of the PIVOTAL Phase III results previously published in Annals of Oncology in 2025 (Kähler et al., Annals of Oncology, 2025, 36, 1166). While the previous publication reported the primary recurrence-free survival analysis at a median follow-up of less than two years, the updated JCO analysis reports efficacy and safety results at a median follow-up of approximately three years from randomization and includes additional post-hoc analyses of event-free survival (EFS).

At the longer follow-up, the updated analysis confirmed a clinically and statistically significant improvement in recurrence-free survival (RFS) for patients receiving neoadjuvant Nidlegy followed by surgery compared with patients undergoing upfront surgery. The hazard ratio for recurrence or death was 0.55 (95% CI, 0.38- 0.78; P<0.001), corresponding to a 45% reduction in the hazard of recurrence or death. Median RFS was 23.8 months in the Nidlegy plus surgery arm compared with 6.5 months in the surgery-only arm. The 3-year RFS rates were 35.7% and 16.6%, respectively.

The updated analysis also confirmed a significant benefit in distant metastasis-free survival (DMFS), with a hazard ratio of 0.53 (95% CI, 0.33-0.83; P=0.005). Median DMFS was 38.7 months in the Nidlegy plus surgery arm compared with 14.0 months in the surgery-only arm, while the 3-year DMFS rates were 51.2% and 28.7%, respectively.

In addition, a post-hoc EFS analysis in the overall study population was consistent with the primary RFS results, with a hazard ratio of 0.71 (95% CI, 0.51-0.98; P=0.034). The publication also reports analyses in patients with recurrent melanoma, who represented 87% of the study population, showing a consistent clinical benefit from neoadjuvant Nidlegy, including in patients who had previously received systemic therapies.

The updated safety profile of Nidlegy remained manageable, with no new safety signals of concern. No treatment-related adverse events above Grade 3 and no treatment-related deaths were reported.

Prof. Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen, commented: "The publication of these updated PIVOTAL results in the Journal of Clinical Oncology provides important longerterm confirmation of the clinical benefit initially reported in Annals of Oncology. With median follow-up now of approximately three years, Nidlegy continues to demonstrate meaningful improvements in recurrencefree and distant metastasis-free survival compared with upfront surgery, with a manageable safety profile and no new safety signals. We are particularly encouraged by the consistency of the results in patients with recurrent melanoma, including patients previously treated with systemic therapies. These findings further support the potential role of Nidlegy as a neoadjuvant treatment for patients with locally advanced, fully resectable melanoma."

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, AUG 17, 2026, View Source [SID1234670178])