Sun Pharma, Philogen complete patient enrollment in Phase III trial for Soft Tissue Sarcoma
Mumbai: Sun Pharmaceutical Industries Limited and Philogen S.p.A. have announced the successful completion of patient enrollment in the Phase III FIBROSARC trial for Soft Tissue Sarcoma (STS). All ongoing Fibromun trials remain on track with their expected timelines.
Dario Neri, CEO of Philogen, commented, "We are highly encouraged by the progress of Fibromun’s pivotal trials in both Soft Tissue Sarcoma and Glioblastoma. In October 2024, the program entered a strategic commercial partnership with Sun Pharma, a multinational pharmaceutical company. The Soft Tissue Sarcoma trials are proceeding as planned across Europe and the United States. Key readouts from our most advanced studies—Phase III FIBROSARC and Phase II FLASH—are anticipated between March and June 2025. These results represent critical milestones for Philogen, as Fibromun has the potential to become our second product to successfully complete multinational clinical trials with registration potential. We are also seeing faster-than-expected patient enrollment in the Glioblastoma trials. The Phase II GLIOSTAR trial, originally projected to complete enrollment by December 2025, is now expected to conclude recruitment in Q2 2025. Philogen remains committed to advancing innovative therapies and delivering meaningful outcomes for patients worldwide.”
Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, said, “We look forward to the Fibromun readouts over the next few months. Fibromun has the potential as a valuable treatment option for soft-tissue sarcomas and other cancers with high unmet medical needs. The candidate aligns well with our current portfolio in skin cancers.”
Fibromun is a biopharmaceutical product, consisting of the L19 antibody fused to tumor necrosis factor (i.e., L19TNF). The status of the ongoing pivotal studies is provided below.
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