Sun Pharma and Philogen announce completion of patient enrollment for Phase III FIBROSARC trial

The trial, conducted across Germany, France, Italy, Spain, and Poland, has exceeded its enrollment target with 129 patients enrolled against the planned 118. Key results from this study are anticipated between March and June 2025.

Sun Pharmaceutical Industries Limited and Philogen S.p.A. have successfully completed patient enrollment for the Phase III FIBROSARC trial in Soft Tissue Sarcoma (STS), marking a significant milestone in their joint efforts to develop innovative oncology treatments.

The FIBROSARC trial, a pivotal Phase III study, aims to evaluate the efficacy of Fibromun (L19TNF) in combination with doxorubicin for the treatment of first-line locally advanced or metastatic STS. The trial, conducted across Germany, France, Italy, Spain, and Poland, has exceeded its enrollment target with 129 patients enrolled against the planned 118. Key results from this study are anticipated between March and June 2025.

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Dario Neri, CEO of Philogen, expressed optimism about the progress of Fibromun’s clinical trials, stating, “We are highly encouraged by the advancements in Fibromun’s pivotal trials in both Soft Tissue Sarcoma and Glioblastoma. The completion of patient enrollment in FIBROSARC brings us one step closer to delivering an effective treatment option for STS patients. We look forward to key data readouts in the coming months.”

Sun Pharma’s Chairman and Managing Director, Dilip Shanghvi, highlighted the significance of this development in expanding the company’s oncology portfolio. “Fibromun has the potential to address high unmet medical needs in STS and other cancers. We eagerly anticipate the upcoming study results and remain committed to advancing innovative therapies,” he said.

The FIBROSARC trial is part of a broader research initiative that includes multiple ongoing clinical studies for Fibromun. The FLASH study, a Phase II trial for last-line STS treatment using Fibromun in combination with dacarbazine, has also exceeded its enrollment target with 94 patients recruited against the planned 86. Study results for FLASH are expected between April and July 2025.

In the United States, the Phase IIb FIBROSARC US study is evaluating Fibromun with doxorubicin in first-line metastatic Leiomyosarcoma patients, with 74 out of the planned 158 patients enrolled so far.

Beyond STS, Fibromun is also being investigated in Glioblastoma (GBM) through multiple clinical trials in Europe and the US. The Phase II GLIOSTAR trial in GBM has accelerated recruitment and is now expected to complete patient enrollment by Q2 2025, ahead of its original December 2025 target. Other GBM trials, including GLIOSTELLA and GLIOSUN, are progressing as planned, with data readouts expected in 2025 and 2026.

Fibromun is a proprietary biopharmaceutical product developed by Philogen, combining the L19 antibody with Tumor Necrosis Factor (TNF) to target tumor cells selectively. It is administered via intravenous infusion and is being explored for its potential to treat various cancers beyond STS and GBM, including lung, breast, colon, and prostate cancers.

Philogen and Sun Pharma have strengthened their collaboration through an exclusive global distribution, licensing, and supply agreement for Fibromun, further solidifying their joint commitment to advancing oncology treatments.

With promising study results on the horizon, the success of these clinical trials could pave the way for regulatory discussions, including a potential pre-Biologics License Application (pre-BLA) meeting with the U.S. FDA to explore accelerated approval pathways.