Sun Pharma Partners Report Clinical Updates on Fibromun and Nidlegy

Sun Pharma Partners Report Clinical Updates on Fibromun and Nidlegy​

Sun Pharmaceutical Industries Limited announced updates on Fibromun and Nidlegy, based on clinical data reported by its partner, Philogen, as part of Philogen’s financial results.

Regarding Fibromun, the Phase II FLASH study in last-line soft tissue sarcoma did not meet its primary endpoint for Progression Free Survival (PFS), enrolling 94 patients randomized 1:1 to receive either Fibromun + dacarbazine or dacarbazine alone. Similarly, the Phase II GLIOSTAR clinical trial in 163 second-line glioblastoma patients also did not meet its primary endpoint. However, survival improvements were observed in GLIOSTAR among patients with limited exposure to alkylating agents.

The GLIOSUN clinical trial, evaluating Fibromun in first-line glioblastoma patients, is in the dose expansion phase. The GLIOSTELLA study for late-line glioblastoma patients has completed patient enrollment in the United States and is expected to report survival data in September 2026.

Following results from the FIBROSARC study, which showed encouraging survival signals in patients with liposarcoma and other sarcoma types, a request for Parallel Scientific Advice has been submitted to the FDA and EMA to define the design of a Phase III registrational study, FIBROSARC-2. The process is expected to conclude in the second quarter of 2026, with the study planned to begin thereafter, using overall survival as the primary endpoint.

For Nidlegy™, a biopharmaceutical product for skin cancer treatment, the company is preparing a new Marketing Authorization Application submission in Europe following the withdrawal of a previous application for the melanoma indication. A Phase III clinical trial in locally advanced melanoma is ongoing in the United States, Spain, and Switzerland. A Type C meeting with the U.S. Food and Drug Administration (FDA) resulted in alignment on a regulatory pathway for approval in the United States, contingent upon the completion and positive outcome of the ongoing study.

The Phase II ‘Duncan’ study in basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) showed complete pathological responses in 52.6% of patients with BCC, and full results from the BCC and cSCC cohorts will be published in 2026. The Phase II ‘Intrinsic’ study, targeting 70 patients with various forms of NMSC, has treated 65 patients in Italy and France.

Based on the results from the 'Duncan' and 'Intrinsic' trials, the company plans to initiate three new registrational studies in Europe and the United States for BCC and cSCC, with patient enrollment expected in the second quarter of 2026. An additional Scientific Advice with the FDA has been completed to define a fourth registrational study in first-line BCC, comparing Nidlegy™ with Hedgehog pathway inhibitors (HHI), with the study expected to start in mid-2026.



The above information is an extract from Philogen’s financial results release.

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