Shares of Sun Pharmaceutical Industries will be in focus on Wednesday, November 12, after the company announced that its partner Philogen S.p.A. has shared encouraging updates on the Fibromun (L19TNF) clinical program, including results from the Phase III FIBROSARC trial for advanced or metastatic soft tissue sarcoma (STS).
According to the press release, the FIBROSARC trial, which compared Fibromun plus doxorubicin against doxorubicin alone, did not meet its primary endpoint of Progression-Free Survival (PFS) in the final analysis. However, the data showed promising trends in overall survival (OS), objective response rate (ORR), and PFS, favoring the combination therapy.
Key findings from the FIBROSARC study
At the time of the final analysis involving 131 randomized patients and 92 PFS events:
- Median PFS (mPFS) was 7.9 months for the combination arm versus 4.6 months for doxorubicin alone.
- Objective Response Rate (ORR) stood at 19% with Fibromun plus doxorubicin compared to 14.3% with doxorubicin alone.
- Median Overall Survival (mOS) reached 28.3 months versus 19.6 months for the control group, though the OS data remain immature with 54 events recorded so far.
Philogen stated that it plans to initiate a confirmatory Phase III trial in 2026, focusing on overall survival as the primary endpoint, after discussions with regulatory authorities in Europe and the United States.
Additional ongoing trials
Philogen is advancing several other trials in the Fibromun program:
- FLASH (Phase II) – Evaluating Fibromun plus dacarbazine in last-line STS; final results expected by the end of 2025.
- FIBROSARC US (Phase IIb) – Assessing Fibromun with doxorubicin in metastatic leiomyosarcoma; interim analysis in Q1 2026.
Fibromun has been granted orphan drug designation for STS and glioma by both the European Commission and the U.S. FDA.
Glioblastoma program updates
Philogen also shared progress from its glioblastoma studies:
- GLIOSUN (Phase I/II/IIb) – Combining Fibromun with chemoradiotherapy in newly diagnosed patients. Early results showed a median OS of 17.8 months among patients with an unmethylated MGMT promoter.
- GLIOSTAR (Phase II) – Combination with lomustine in recurrent glioblastoma; final OS events expected in Q1 2026.
- GLIOSTELLA (Phase II) – Focused on dose optimization and efficacy, with mature data expected in 2026.
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