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Sun Pharma and Philogen Complete Enrollment for Pivotal Phase III FIBROSARC Trial in Soft Tissue Sarcoma

• Sun Pharmaceutical Industries and Philogen have successfully completed patient enrollment in the Phase III FIBROSARC trial for Soft Tissue Sarcoma, with key readouts expected between March and June 2025.

• The FIBROSARC study, conducted across five European countries, has enrolled 129 patients to evaluate Fibromun in combination with Doxorubicin for first-line treatment of locally advanced or metastatic STS.

• Multiple parallel trials of Fibromun are progressing ahead of schedule, including studies in glioblastoma, with the Phase II GLIOSTAR trial now expected to complete enrollment by Q2 2025.

Sun Pharmaceutical Industries Limited and Philogen S.p.A. have reached a significant milestone in their oncology program with the completion of patient enrollment in the Phase III FIBROSARC trial, investigating Fibromun for Soft Tissue Sarcoma (STS). The study has surpassed its target, enrolling 129 patients against the planned 118.
The FIBROSARC trial, spanning across Germany, France, Italy, Spain, and Poland, evaluates Fibromun in combination with Doxorubicin as a first-line treatment for locally advanced or metastatic STS. Key efficacy data from this pivotal study is anticipated between March and June 2025.

Strategic Partnership and Development Program

Fibromun, a biopharmaceutical product combining the L19 antibody with tumor necrosis factor (L19TNF), represents a novel approach in oncology treatment. The development program gained momentum following a strategic commercial partnership between Philogen and Sun Pharma in October 2024.
"We are highly encouraged by the progress of Fibromun's pivotal trials in both Soft Tissue Sarcoma and Glioblastoma," stated Dario Neri, CEO of Philogen. "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."

Parallel Clinical Development Activities

The development program includes multiple concurrent trials:
  • FLASH Study: A Phase II European trial for last-line STS treatment, combining Fibromun with Dacarbazine, has enrolled 94 patients (target: 86)
  • US FIBROSARC: An ongoing Phase IIb study in metastatic Leiomyosarcoma has recruited 74 out of 158 planned patients
  • GLIOSTAR: The glioblastoma program is advancing ahead of schedule, with Phase II enrollment expected to complete in Q2 2025

Commercial Potential and Market Impact

Dilip Shanghvi, Chairman and Managing Director of Sun Pharma, expressed optimism about the program: "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."
The companies plan to pursue accelerated approval procedures with the FDA pending positive trial outcomes. This strategic development builds upon their existing collaboration for Nidlegy in Europe, Australia, and New Zealand, strengthening their global oncology presence.
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Reference News

[1]
Philogen completes patient enrollment of Phase III FIBROSARC trial in Soft Tissue Sarcoma
indianpharmapost.com · Feb 6, 2025
[2]
Sun Pharma, Philogen complete patient enrollment in Phase III trial for Soft Tissue Sarcoma
medicaldialogues.in · Feb 7, 2025

Sun Pharma and Philogen completed patient enrollment for the Phase III FIBROSARC trial in Soft Tissue Sarcoma. Fibromun ...

[3]
Sun Pharma and Philogen complete patient enrollment for Phase III soft tissue sarcoma trial
expresspharma.in · Feb 10, 2025
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