Philogen provides update on Fibromun clinical study developments

FIBROSARC is a randomized, controlled Phase III clinical trial evaluating the use of fibromun in combination with doxorubicin, compared with doxorubicin alone as first-line treatment in patients with advanced or metastatic STS. Patients with leiomyosarcoma, liposarcoma, and other rare histologies were enrolled in the study. The primary endpoint was Progression-Free Survival (PFS), while Overall Survival (OS) is a secondary endpoint.

Although FIBROSARC did not meet its primary PFS endpoint in the final analysis, the results indicate promising trends for PFS, ORR, and OS favoring patients treated with fibromun plus doxorubicin, over the doxorubicin monotherapy arm.

At the time of the final analysis of the primary endpoint PFS (131 randomized patients; 92 PFS events):

- mPFS was 7.9 months for the fibromun plus doxorubicin arm versus 4.6 months for doxorubicin alone. Hazard Ratio proportionality was observed at interim analysis, but not at the final analysis

- Objective Response Rate (ORR) was 19.0% with the combination versus 14.3% with doxorubicin alone

- Median OS (mOS) was 28.3 months in the fibromun plus doxorubicin arm versus 19.6 months in the doxorubicin arm. The OS data are immature, with only 54 OS events at the time of this analysis.

The results from FIBROSARC will be presented at upcoming scientific conferences and submitted for publication in a peer-reviewed journal in 2026.

Encouraged by these data and in consideration of the substantial unmet medical need for patients with advanced or metastatic STS, Philogen plans to discuss the results with European and US authorities and to initiate a Philogen-sponsored confirmatory Phase III trial with OS as the primary endpoint. Such a new study is expected to start in 2026.

Prof. Dr. Christoph Schliemann (UK Münster), the Coordinator of the study and the Principal Investigator of the center that had enrolled the largest number of patients, commented: "Fibromun is showing signs of activity in a very difficult-to-treat indication. We remain interested in future applications of this investigational study drug. We are eager to learn about the evolution of overall survival data."

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SunPharmaceuticalIndustries INE044A01036 Philogen FIBROSARC