Sun Pharmaceutical Industries has announced significant updates regarding its partner Philogen‘s clinical trials for Fibromun and Nidlegy. The updates were disclosed as part of Philogen’s financial results.
Fibromun, which is being evaluated in the treatment of soft tissue sarcoma (STS) and glioblastoma, showed mixed results. The Phase II FLASH study, involving 94 patients with last-line soft tissue sarcoma, did not meet its primary endpoint for Progression Free Survival (PFS). Despite this, Sun Pharmaceutical remains committed to exploring innovative therapeutic approaches to improve outcomes for STS patients.
In glioblastoma studies, the Phase II GLIOSTAR trial, conducted with 163 second-line patients, also did not meet its primary endpoint. However, there was an observed improvement in survival in a subgroup of patients with limited exposure to alkylating agents. The company is continuing with the GLIOSUN trial, targeting treatment-naïve glioblastoma patients, which has completed its dose escalation phase and is moving into the dose expansion phase. Additionally, the GLIOSTELLA study in late-line glioblastoma patients has completed enrollment in the United States, with survival data expected in September 2026.
For soft tissue sarcoma, following the promising results from the FIBROSARC study, Sun Pharmaceutical has requested Parallel Scientific Advice from the FDA and EMA for a new Phase III registrational study, FIBROSARC-2, focusing on overall survival as the primary endpoint.
Regarding Nidlegy, developed for skin cancers, Sun Pharmaceutical is preparing a new Marketing Authorization Application in Europe following the withdrawal of the previous application in 2025. A Phase III trial in locally advanced melanoma is ongoing in the United States, Spain, and Switzerland. A Type C meeting with the FDA in March 2026 provided alignment on the regulatory pathway for melanoma approval, contingent on the ongoing study’s completion and positive outcome.
In non-melanoma skin cancer (NMSC), the Phase II “Duncan” study for basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) showed excellent results, with 52.6% of BCC patients achieving complete pathological responses. The full results will be published in 2026. The ongoing Phase II “Intrinsic” study has treated 65 patients in Italy and France, targeting 70 patients with various forms of NMSC.
The positive outcomes from the “Duncan” and “Intrinsic” trials have led to the initiation of three new registrational studies in Europe and the United States for BCC and cSCC. Additionally, a fourth study in first-line BCC comparing Nidlegy with Hedgehog pathway inhibitors is planned to start in mid-2026.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).