FDA Approves New Indication for Lonsurf in Combination with Bevacizumab for Metastatic Colorectal Cancer

On August 3, TAIHO Oncology and Servier jointly announced that the new indication application for the combination therapy Lonsurf (trifluridine + tipiracil) has been approved by the FDA for use in combination with the VEGF antibody bevacizumab to treat patients with metastatic colorectal cancer (mCRC).

Lonsurf is an oral nucleoside antineoplastic drug, consisting of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase (TP) inhibitor tipiracil. Tipiracil increases the exposure of trifluridine in the body by inhibiting TP-mediated metabolism of trifluridine, promoting the incorporation of trifluridine into DNA, which subsequently leads to DNA dysfunction and suppression of cell proliferation.

In March 2014, Lonsurf was approved for the first time in Japan for the treatment of unresectable advanced or recurrent colorectal cancer. In September 2015, Lonsurf was approved for the first time in the United States for the treatment of adult patients with mCRC who have received or are unsuitable for existing therapies (including chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, anti-VEGF antibodies, and anti-EGFR therapy (if the patient’s RAS is wild-type)).

The approval of this new indication is mainly based on the positive data from the Phase III SUNLIGHT study. The results showed that in adult patients with mCRC who had received or were unsuitable for chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, anti-VEGF agents, and anti-EGFR therapy (if the patient’s RAS was wild-type), the Lonsurf plus bevacizumab treatment group demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared to the Lonsurf treatment group.

Results showed that the median OS was 10.8 months in the Lonsurf plus bevacizumab group, compared to 7.5 months in the Lonsurf group (HR: 0.61, 95% CI: 0.49-0.77, p<0.001); the median PFS was 5.6 months in the Lonsurf plus bevacizumab group, versus only 2.4 months in the Lonsurf group (HR: 0.44, 95% CI: 0.36-0.54, p<0.001). Additionally, Lonsurf plus bevacizumab was well tolerated, with no new safety signals observed.

Lonsurf was developed by TAIHO. In June 2015, Servier signed a $130 million agreement with TAIHO to obtain the commercialization rights for Lonsurf in the European market and other markets (excluding the United States, Canada, Mexico, and Asia).

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