Philogen’s Soft Tissue Sarcoma Trial Moves Closer to Key Results

Key Takeaways

• Philogen and Sun Pharma have completed patient enrollment for the Phase III FIBROSARC trial in soft tissue sarcoma (STS).
• The trial results are expected between March and June 2025, with potential for regulatory discussions with the FDA.
• Philogen’s Fibromun, a biopharmaceutical candidate, is being tested for STS and glioblastoma, with multiple trials progressing globally.

Philogen S.p.A., in partnership with Sun Pharmaceutical Industries Ltd., has successfully completed patient enrollment for its Phase III FIBROSARC trial evaluating Fibromun in soft tissue sarcoma (STS). Conducted across Germany, France, Italy, Spain, and Poland, the study investigates Fibromun in combination with doxorubicin as a first-line treatment for advanced or metastatic STS.

With 129 patients enrolled, exceeding the original target of 118, the trial remains on schedule, with study readouts anticipated between March and June 2025. A positive outcome could enable Philogen to seek regulatory discussions with the FDA for potential accelerated approval in the U.S.

Fibromun’s Progress in Oncology Clinical Trials

Fibromun, a biopharmaceutical therapy combining the L19 antibody with tumor necrosis factor (TNF), is undergoing multiple late-stage trials:

• Phase II FLASH trial (STS, Europe): 94 patients enrolled, results expected April–July 2025.
• Phase IIb FIBROSARC US trial (Leiomyosarcoma, U.S.): Enrollment ongoing.
• Phase II GLIOSTAR trial (Glioblastoma, EU): Expected completion by Q2 2025.
• Phase I/II GLIOSTELLA trial (Glioblastoma, U.S.): Enrollment expected to conclude Q4 2025–Q1 2026.

Philogen and Sun Pharma have a global commercialization agreement for Fibromun, reinforcing their existing collaboration in oncology. If successful, Fibromun could offer a new treatment option for STS and potentially other cancers with high unmet medical needs.

Source

Elham Talatghoushchi