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.
• European Phase III study STS (FIBROSARC study)
o Patient population: first line locally advanced or metastatic STS
o Combination partner: Doxorubicin
o Geography: Germany, France, Italy, Spain, Poland
o Enrolment Status: 129 out of 118 patients
o Study read-out expected between March and June 2025, based on the occurrence of the events
o If the trial reads-out positively, Philogen plans to request a pre-BLA meeting with FDA to discuss opportunities for accelerated approval procedures in the US
• European Phase II study STS (FLASH study)
o Patient population: last line locally advanced or metastatic STS
o Combination partner: Dacarbazine
o Geography: Germany, France, Italy, Spain, Poland
o Enrolment Status: 94 out of 86 patients
o Study read-out expected between April and July 2025, based on the occurrence of the events
o If the trial reads-out positively, Philogen plans to request a pre-BLA meeting with FDA to discuss opportunities for accelerated approval procedures in the US
• US Phase IIb study STS (FIBROSARC US study)
o Patient population: first line metastatic Leiomyosarcoma
o Combination partner: Doxorubicin
o Geography: US
o Enrolment Status: 74 out of 158 patients
• EU Phase I/II study GBM (GLIOSTAR study)
o Patient population: GBM at first progression
o Combination partner: Lomustine
o Geography: Italy, Switzerland, Germany, France
o Enrolment Status Phase 1: complete
o Enrolment Status Phase 2: 139 out of 158 patients
o Expected completion of enrolment between April and June 2025
• US Phase I/II study GBM (GLIOSTELLA study)
o Patient population: GBM at first or later progression
o Combination partner: Lomustine o Geography: US
o Enrolment Status: 36 out of up to 90 patients
o Expected completion of enrolment Q4 2025 – Q1 2026
• EU Phase I/II/IIb study GBM (GLIOSUN study)
o Patient population: newly diagnosed GBM
o Combination partner: Radiotherapy and Temozolomide
o Geography: Switzerland. Expansion to European countries ongoing
o Enrolment Status Phase 1: complete
o Enrolment Status Phase 2: in preparation
o Data on the Phase 1 part of the study will be presented in 2025
Philogen has entered an Exclusive Distribution, License, and Supply Agreement with Sun Pharma for commercializing Fibromun globally, which strengthens their ongoing collaboration on Nidlegy in Europe, Australia and New Zealand.
