Sun Pharmaceutical Industries Limited, in partnership with Philogen S.p.A., is conducting a pivotal Phase III trial evaluating FibroMUN, an innovative immunotherapy, combined with Doxorubicin for advanced soft tissue sarcoma, with results expected between March and June 2025.
Sun Pharma, a leading multinational pharmaceutical company, along with its partner Philogen S.p.A., has successfully completed patient enrollment in the ongoing Phase III FIBROSARC clinical trial. This trial evaluates the efficacy and safety of FibroMUN, a biopharmaceutical composed of the L19 antibody fused to tumor necrosis factor (L19TNF), in combination with the chemotherapy drug Doxorubicin for treatment of first-line locally advanced or metastatic soft tissue sarcoma (STS).
The multinational study spans key European countries including Germany, France, Italy, Spain, and Poland. Preliminary timelines indicate key study readouts will be available between March and June 2025. Positive outcomes may open paths for regulatory approvals and potential accelerated pathways in major markets like the US.
Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, expressed optimism about FibroMUN’s potential as a valuable treatment option addressing unmet medical needs in aggressive cancers like STS, complementing Sun Pharma’s existing oncology portfolio.
CEO of Philogen, Dario Neri, highlighted the promising enrollment pace and broader pipeline progress, including glioblastoma trials, reinforcing the strategic partnership’s commitment to delivering breakthrough therapies.
Key Highlights
Phase III FIBROSARC trial evaluating FibroMUN + Doxorubicin for advanced soft tissue sarcoma.
Completed enrollment of 129 patients across Germany, France, Italy, Spain, and Poland.
Study readout expected between March and June 2025 with registration potential.
FibroMUN consists of L19 antibody fused with tumor necrosis factor (L19TNF).
Philogen and Sun Pharma’s strategic partnership drives innovative oncology pipeline.
Potential for accelerated regulatory approvals based on trial outcomes.
Ongoing related trials include Phase II glioblastoma study with strong enrollment progress.
Sources: Sun Pharmaceutical Industries Limited official releases, Philogen S.p.A. announcements, Medical Dialogues, Express Pharma, BusinessUpturn