Sun Pharma and Philogen complete patient enrollment for Phase III soft tissue sarcoma trial
Philogen and Sun Pharma announce the completion of patient enrollment in the Phase III FIBROSARC trial for soft tissue sarcoma, with key study readouts expected between March and June 2025
Sun Pharmaceutical Industries and Philogen S.p.A. have completed patient enrollment in the Phase III FIBROSARC trial for Soft Tissue Sarcoma (STS). All ongoing trials for Fibromun, an investigational biopharmaceutical product, remain on track with their expected timelines.
Dario Neri, CEO of Philogen, stated, “We are highly encouraged by the progress of Fibromun’s pivotal trials in both soft tissue sarcoma and glioblastoma. In October 2024, the programme entered a strategic commercial partnership with Sun Pharma, a leading multinational pharmaceutical company.”
The soft tissue sarcoma trials are progressing as planned across Europe and the United States. Key study readouts for Phase III FIBROSARC and Phase II FLASH are expected between March and June 2025. Neri added, “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.”
Philogen has reported a faster-than-anticipated patient enrollment for its glioblastoma trials. The Phase II GLIOSTAR trial, initially projected to complete recruitment by December 2025, is now expected to conclude enrollment in Q2 2025.
Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, stated, “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 consists of the L19 antibody fused to tumour necrosis factor (L19TNF). The status of ongoing pivotal studies is progressing across multiple regions for both soft tissue sarcoma and glioblastoma. In Europe, the Phase III FIBROSARC study, which targets first-line locally advanced or metastatic STS, is currently enrolling 129 out of 118 patients, with results expected between March and June 2025. A positive outcome could lead Philogen to request a pre-BLA meeting with the FDA for potential accelerated approval in the United States.
The Phase II FLASH study, also in Europe, is focusing on patients with last-line locally advanced or metastatic STS, and is expected to complete its enrollment of 94 patients by April to July 2025, with the same potential for accelerated approval if successful results are achieved.
In the United States, the Phase IIb FIBROSARC trial is focused on first-line metastatic leiomyosarcoma, with 74 out of 158 patients enrolled to date.
Philogen’s glioblastoma trials are also moving forward, with Phase I of the GLIOSTAR study in Europe completed. The Phase II part of the study, which targets glioblastoma at first progression, is expected to complete enrollment between April and June 2025, with 139 of 158 patients already enrolled.
In the U.S., the Phase I/II GLIOSTELLA trial is enrolling patients with glioblastoma at first or later progression, with 36 out of 90 patients recruited so far. The study is expected to complete enrollment between Q4 2025 and Q1 2026.
Philogen has entered an Exclusive Distribution, Licence, and Supply Agreement with Sun Pharma for the global commercialisation of Fibromun. This strengthens their collaboration on Nidlegy, currently being developed for melanoma and non-melanoma skin cancers in Europe, Australia, and New Zealand.