By: IPP Bureau
Last updated : April 04, 2026 8:18 am
The company has highlighted setbacks in Phase II studies while outlining fresh regulatory and late-stage development plans for Fibromun and Nidlegy
Sun Pharmaceutical Industries has informed the National Stock Exchange (NSE) about important clinical updates on Fibromun and Nidlegy, based on disclosures shared by its partner Philogen as part of its financial results.
In the regulatory filing dated March 28, 2026, Sun Pharma said the Phase II FLASH study in last-line soft tissue sarcoma did not meet its primary endpoint of progression-free survival (PFS).
The company also said that the Phase II GLIOSTAR trial in second-line glioblastoma failed to meet its primary endpoint, underlining the persistent challenges in treating this difficult cancer. However, Sun noted that the study showed improved survival in a subgroup of patients with limited prior exposure to alkylating agents, offering a potentially meaningful signal for future development.
In its statement to the NSE, Sun Pharma emphasized that it remains committed to the GLIOSUN trial in treatment-naïve glioblastoma, which has completed dose escalation and is moving into dose expansion. The company further added that the GLIOSTELLA study in late-line glioblastoma has completed patient enrolment in the United States and is expected to report survival data in September 2026.
Despite the Phase II setbacks, Sun Pharma highlighted encouraging survival signals from the earlier FIBROSARC study in first-line soft tissue sarcoma, particularly in patients with liposarcoma and related sarcoma subtypes. Based on these findings, a parallel scientific advice request has been submitted to the US FDA and EMA to finalize the design of a new Phase III registrational study, FIBROSARC-2, which is expected to begin after regulatory feedback in the second quarter of 2026.
The filing also included positive progress on Nidlegy, where the company said it is preparing a fresh European submission for melanoma this year, while the ongoing US Phase III melanoma trial continues to expand geographically. Additional registrational studies in basal cell carcinoma and cutaneous squamous cell carcinoma are also expected to begin in Q2 2026, reinforcing Sun Pharma’s strategic oncology pipeline ambitions.