Results of Phase III PIVOTAL trial of Nidlegy in melanoma to be presented at ASCO 2024

Mumbai: Philogen S.p.A. and Sun Pharmaceutical Industries Limited have announced that the primary results of the Nidlegy Phase III PIVOTAL trial (NCT02938299) will be the object of an oral presentation at ASCO by Prof. Dr. Axel Hauschild (Abstract #LBA9501).

PIVOTAL (NCT02938299) is an open label, randomized, multicenter, Phase III trial evaluating Nidlegy as a neoadjuvant intralesional therapy for fully resectable, locally advanced melanoma. The primary endpoint of the study was recurrence-free survival (RFS), assessed by investigators and confirmed by retrospective Blinded Independent Central Review (BICR) of PET/CT scans.

The study was conducted at 22 sites in 4 European countries and enrolled a total of 256 patients 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.

“We look forward to Axel Hauschild’s presentation of the PIVOTAL primary results. These are exciting days for the Company: while PIVOTAL is the most advanced Phase III trial to be completed, we expect the readout of at least six additional ongoing studies with registration potential in the near future,” commented Alfredo Covelli, M.D., Chief Medical Officer, Philogen.

Hellen De Kloet, Business Head - Western Europe and ANZ, Sun Pharma, said, “Sun and Philogen have had a fruitful partnership over the past year, wherein Nidlegy has continued to progress in its journey towards the market. Upon approval, Nidlegy is expected to address a significant unmet clinical need for patients suffering from this life-threatening disease. We are looking forward to the data presentation of the PIVOTAL results.”

The primary outcome analysis shows that the RFS HR between the treatment and the control arm is 0.59 [95% CI 0.41-0.86; log-rank p=0.005] as per BICR assessment and 0.61 [0.41-0.92; p=0.018] as per investigator assessment (power = 85%; two-sided α = 0.05). Median RFS was 16.7 months in the treatment and 6.9 months in the control arm as per BICR. Moreover, distant metastasis-free survival (DMFS) was significantly improved by the neoadjuvant treatment, with an HR between the two arms of 0.60 [0.37-0.95; p=0.029]. 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.

Collectively, the analysis of primary (RFS) and secondary (DMFS and safety) endpoints show that neoadjuvant Nidlegy is an effective therapeutic option for this patient population.

Philogen and Sun Pharma entered into a distribution, license and supply agreement in May 2023 for commercializing Nidlegy in Europe, Australia and New Zealand for the treatment of skin cancers. In October 2023, both companies announced that PIVOTAL met the primary endpoint of recurrence-free survival. Nidlegy is the first immunocytokine product for which positive Phase III data have been reported.

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