Setback to Sun Pharma as Fibromun, Nidlegy Trials Miss Key Endpoints in Cancer Studies
New Delhi: Sun Pharmaceutical Industries Limited has shared clinical updates on Fibromun and Nidlegy, with key studies failing to meet primary endpoints while further trials and regulatory pathways continue to advance.
The company informed that its partner Philogen reported results from multiple ongoing and completed clinical trials as part of its financial disclosures. In the Phase II FLASH study involving patients with advanced soft tissue sarcoma, Fibromun in combination with dacarbazine did not meet the primary endpoint of progression-free survival. The study enrolled 94 patients randomized to receive either the combination therapy or dacarbazine alone.
Similarly, the Phase II GLIOSTAR trial in 163 second-line glioblastoma patients also failed to achieve its primary endpoint. However, an improvement in survival was observed in a subgroup of patients with limited prior exposure to alkylating agents, indicating potential benefits in select patient populations.
Despite these setbacks, Sun Pharma highlighted ongoing efforts in glioblastoma research. The GLIOSUN trial in treatment-naïve patients has completed its dose escalation phase and is moving into dose expansion. Another study, GLIOSTELLA, targeting late-line glioblastoma patients in the United States, has completed patient enrollment and is expected to report survival data by September 2026.
In soft tissue sarcoma, encouraging survival signals from the FIBROSARC study have prompted plans for a new Phase III registrational trial (FIBROSARC-2), with overall survival as the primary endpoint. The company has sought parallel scientific advice from the US FDA and the European Medicines Agency to finalize the study design.
On Nidlegy, a biopharmaceutical product for skin cancers, the company is preparing for a fresh regulatory submission in Europe following the withdrawal of its earlier application for melanoma. In the United States, a Phase III trial in locally advanced melanoma is ongoing, with regulatory alignment achieved with the FDA through a Type C meeting.
Additionally, strong results from Phase II studies in non-melanoma skin cancers, including basal cell carcinoma and cutaneous squamous cell carcinoma, have shown promising response rates. These findings have supported the initiation of multiple new registrational studies across Europe and the United States, expected to begin in 2026.
Sun Pharma emphasized its continued commitment to advancing innovative therapies despite challenges in complex disease areas with high unmet medical needs.
