Sun Pharma’s partner, Philogen, released clinical updates for its assets Fibromun and Nidlegy. The Phase II FLASH study for Fibromun in soft tissue sarcoma did not meet its primary endpoint for PFS. Conversely, Nidlegy showed excellent results in BCC, achieving complete pathological responses in 52.6% of patients in the Phase II ‘Duncan’ study, paving the way for new registrational trials.
Fibromun Clinical Trial Results (STS & Glioblastoma)
Clinical updates were provided for Fibromun, primarily concerning its studies in soft tissue sarcoma (STS) and glioblastoma. The Phase II FLASH study in last-line STS, which randomized 94 patients, failed to meet its primary endpoint of Progression Free Survival (PFS). The company, however, remains committed to advancing innovative approaches for this challenging disease.
Regarding glioblastoma, the Phase II GLIOSTAR trial in 163 second-line patients also did not meet its primary endpoint. Interestingly, an improvement in survival was noted in the subgroup with limited exposure to alkylating agents. Commitment continues for the GLIOSUN trial in treatment-naïve patients, which has completed dose escalation and is entering dose expansion.
The GLIOSTELLA study in late-line glioblastoma has completed enrollment in the U.S. and is expected to report survival data in September 2026. Following encouraging signals from the FIBROSARC study in first-line STS, a request for Parallel Scientific Advice with the FDA and EMA has been submitted to define the design for a new Phase III registrational study (FIBROSARC-2), with commencement expected after Q2 2026.
Nidlegy™ Updates in Skin Cancers
Significant positive progress was reported for Nidlegy™, a biopharmaceutical product for skin cancer treatment. Following the withdrawal of a prior Marketing Authorization Application in 2025 for melanoma in Europe, the company is preparing a new submission during the current year.
Melanoma and NMSC Progress in the U.S.
In the U.S., a Phase III trial in locally advanced melanoma is ongoing, with a Type C meeting held with the FDA in March 2026 to align on the regulatory pathway for U.S. approval, contingent on positive study outcomes.
Within the Non-Melanoma Skin Cancer (NMSC) program, the Phase II “Duncan” study in basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) demonstrated excellent results in BCC. Complete pathological responses were reported in 52.6% of BCC patients at the ESMO 2025 conference, with full results due in 2026.
The Phase II “Intrinsic” study for NMSC is currently ongoing, having treated 65 patients out of a target of 70. These positive results have provided a strong rationale for initiating three new registrational studies in BCC and cSCC in Europe and the U.S., with enrollment expected to begin in Q2 2026.
Furthermore, an additional Scientific Advice session with the FDA defined a fourth registrational study for first-line BCC, comparing Nidlegy™ against Hedgehog pathway inhibitors (HHI), with the study start anticipated in mid-2026.
Source: BSE
