Shares of Sun Pharmaceutical Industries Ltd fell to Rs 1,712.20 on Tuesday after the company’s partner Philogen S.p.A. announced that its key oncology candidate Fibromun (L19TNF) failed to meet the primary endpoint in its Phase III FIBROSARC trial for advanced or metastatic soft tissue sarcoma (STS).
According to the press release, the FIBROSARC study, which compared Fibromun plus doxorubicin against doxorubicin alone, did not meet its primary endpoint of Progression-Free Survival (PFS) in the final analysis. Despite this, the data indicated promising secondary outcomes such as improved overall survival (OS) and objective response rate (ORR) in favor of the combination therapy.
The key findings showed:
- Median PFS: 7.9 months for the combination arm vs 4.6 months for the control group.
- Objective Response Rate (ORR): 19% vs 14.3%.
- Median Overall Survival (mOS): 28.3 months vs 19.6 months, though the OS data remain immature.
Philogen plans to initiate a confirmatory Phase III trial in 2026, focusing on overall survival as the primary endpoint after discussions with regulators in the U.S. and Europe.
While the overall trends were encouraging, the failure to meet the key efficacy benchmark (PFS) weighed on investor sentiment. This outcome is seen as a short-term setback for Sun Pharma, which has a license and supply agreement with Philogen to commercialize Fibromun — a potential cancer treatment candidate.
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