Philogen, a partner of Sun Pharma, has released an update on its Fibromun clinical study. While the FIBROSARC trial did not meet its primary endpoint, results show promising trends for patients treated with fibromun plus doxorubicin. Philogen plans discussions with authorities and a confirmatory Phase III trial with OS as the primary endpoint is expected to start in 2026. Additional trials for Glioblastoma are in progress.
Fibromun in Fibrosarc Clinical Trial Update
FIBROSARC, a Phase III clinical trial evaluating fibromun combined with doxorubicin for advanced or metastatic soft tissue sarcoma (STS), showed promising results even though it did not meet its primary endpoint (Progression-Free Survival – PFS). The results indicated positive trends in PFS, Objective Response Rate (ORR), and Overall Survival (OS) for patients treated with fibromun plus doxorubicin.
Key Data Points from FIBROSARC
Key findings from the final analysis of the primary endpoint PFS (131 randomized patients; 92 PFS events) include:
- mPFS (median Progression-Free Survival): 7.9 months for fibromun plus doxorubicin versus 4.6 months for doxorubicin alone.
- ORR (Objective Response Rate): 19.0% with the combination versus 14.3% with doxorubicin alone.
- mOS (median Overall Survival): 28.3 months in the fibromun plus doxorubicin arm versus 19.6 months in the doxorubicin arm.
Results from FIBROSARC are expected to be presented at scientific conferences, with publication in a peer-reviewed journal anticipated in 2026.
Plans for Future Trials
Philogen intends to engage with European and US authorities to discuss initiating a confirmatory Phase III trial with OS as the primary endpoint. This new study is projected to commence in 2026.
Other Soft Tissue Sarcoma (STS) Programs
FLASH: A Phase II trial evaluating Fibromun with Dacarbazine for advanced or metastatic soft tissue sarcoma. Final study readout is expected by the end of 2025.
FIBROSARC US: A Phase IIb trial evaluating Fibromun in combination with Doxorubicin as first-line treatment. An interim analysis is expected in Q1 2026.
Glioblastoma Program Updates
GLIOSUN: A Phase I/II/IIb trial in newly diagnosed Glioblastoma. The Phase I part of the trial with 18 patients has been completed.
GLIOSTAR: A Phase I/II trial in patients with Glioblastoma at first recurrence. Final analysis is expected for Q1 2026.
GLIOSTELLA: A Phase II trial in patients with glioblastoma at first or later recurrence. Mature data are expected in 2026.
Source: BSE
