Sun Pharma's Fibromun and Nidlegy Trials Show Mixed Results, New Registrational Studies Planned
Sun Pharma's partner Philogen reported mixed results for Fibromun in soft tissue sarcoma and glioblastoma. New registrational studies (FIBROSARC-2, BCC, cSCC) are planned for Q2 2026 and mid-2026. Nidlegy™ shows promise in skin cancers, with a US melanoma trial ongoing and new submissions planned in Europe.
The mixed results from key clinical trials and the subsequent planning of new registrational studies indicate a significant, but not immediately decisive, impact on the company's future drug development and market potential in oncology.
The announcement contains both positive and negative clinical trial updates. While some trials did not meet primary endpoints, there are promising results in specific patient subgroups and plans for new registrational studies, balancing the overall sentiment.
Sun Pharmaceutical Industries Limited announced updates on its partner Philogen's clinical trials for Fibromun and Nidlegy. The Phase II FLASH study for soft tissue sarcoma did not meet its primary endpoint for Progression Free Survival (PFS), and the Phase II GLIOSTAR trial for glioblastoma also failed to meet its primary endpoint. However, an improvement in survival was observed in a subgroup of glioblastoma patients with limited exposure to alkylating agents. Sun Pharma remains committed to the GLIOSUN trial for first-line glioblastoma patients and the GLIOSTELLA study, which is expected to report survival data in September 2026.
Following encouraging signals from the FIBROSARC study in first-line soft tissue sarcoma, a request for Parallel Scientific Advice with the FDA and EMA has been submitted to define a new Phase III registrational study (FIBROSARC-2), with a conclusion expected in the second quarter of 2026 and study initiation thereafter.
Regarding Nidlegy™ for skin cancers, Sun Pharma is preparing a new Marketing Authorization Application submission in Europe this year, following a withdrawal in 2025. A Phase III clinical trial in locally advanced melanoma is ongoing in the US, with alignment reached with the FDA on the regulatory pathway, subject to study completion. The Phase II “Duncan” study in basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) showed excellent results, with complete pathological responses in 52.6% of BCC patients. Full results will be published in 2026.
Based on positive results from the “Duncan” and “Intrinsic” trials, three new registrational studies in BCC and cSCC are planned to initiate in the second quarter of 2026 in Europe and the United States. Additionally, a fourth registrational study comparing Nidlegy™ with Hedgehog pathway inhibitors in first-line BCC is expected to start in mid-2026.
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