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Sun Pharmaceutical Industries Ltd and Philogen S.p.A. have announced results from the Phase III PIVOTAL trial, focused on patients with locally advanced, fully resectable melanoma. The study assessed neoadjuvant intratumoral Nidlegy (Daromun), followed by surgery, comparing it to surgery alone, with approved adjuvant systemic therapies allowed after surgery in both arms.
The primary objective of the study, Recurrence-Free Survival (RFS) assessed per Blinded Independent Central Review (BICR) for patients treated with Nidlegy compared to the control arm, was successfully met. The treatment arm demonstrated a statistically significant and clinically meaningful improvement in RFS compared to the control arm.
The PIVOTAL trial enrolled 257 patients across 22 clinical centres in Europe, including Germany, Italy, France, and Poland. Results and sub-group analyses will be presented at an upcoming medical meeting.
Nidlegy is also undergoing Phase-II clinical trials for the treatment of high-risk locally advanced basal cell carcinoma and other non-melanoma skin cancers. This development aligns with the ongoing efforts of both Philogen and Sun Pharma to advance cancer treatment options and provide access to innovative therapies.
However, the shares were down by 0.91 per cent at Rs 1,135.9 at 2.56 pm on the BSE
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