Philogen's Fibromun Shows Promising Trends in FIBROSARC Phase III Clinical Trial for Advanced Soft Tissue Sarcoma
Philogen S.p.A has released an update on the FIBROSARC clinical study, a randomized, controlled Phase III trial evaluating the use of fibromun in combination with doxorubicin, compared with doxorubicin alone as first-line treatment in patients with advanced or metastatic soft tissue sarcoma (STS). The trial did not meet its primary Progression-Free Survival (PFS) endpoint, but the results indicate promising trends for PFS, Objective Response Rate (ORR), and Overall Survival (OS) favoring patients treated with fibromun plus doxorubicin, over the doxorubicin monotherapy arm. Philogen plans to discuss the results with European and US authorities and initiate a confirmatory Phase I1II trial with OS as the primary endpoint in 2026. The FIBROSARC study enrolled patients with leiomyosarcoma, liposarcoma, and other rare histologies.
Key Highlights
- FIBROSARC Phase III clinical trial did not meet its primary PFS endpoint but showed promising trends for PFS, ORR, and OS
- Median PFS was 7.9 months for the fibromun plus doxorubicin arm versus 4.6 months for doxorubicin alone
- Objective Response Rate (ORR) was 19.0% with the combination versus 14.3% with doxorubicin alone
- Median OS was 28.3 months in the fibromun plus doxorubicin arm versus 19.6 months in the doxorubicin arm
- Philogen plans to initiate a confirmatory Phase I1II trial with OS as the primary endpoint in 2026