EU CHMP recommends Lonsurf (trifluridine/tipiracil) for metastatic colorectal cancer- Servier

Servier announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending Lonsurf (trifluridine/tipiracil), formerly known as TAS-102, for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

The CHMP positive opinion is based on data from the international, double-blind, placebo-controlled Phase III RECOURSE study, which investigated the efficacy and safety of Lonsurf with best supportive care (BSC) compared to placebo with BSC in 800 patients with previously treated mCRC. The trial met the primary endpoint of statistically significant improvement in overall survival (OS). Results demonstrated a 32% reduction in risk of death compared to BSC and an improvement of 1.8 months of median OS (median OS was 7.1 for Lonsurf vs 5.3 months for placebo). The most frequently observed side effects (at least 30%) in patients receiving Lonsurf were neutropenia, nausea, fatigue, anemia and leucopenia. An updated OS analysis in 89% of events, this year presented at ASCO GI, confirmed the clinically meaningful and statistically significant survival benefit of Lonsurf with BSC compared to placebo with BSC. This translates into a 31% relative reduction in the risk of death and an improvement of 2 months in the median OS. The median OS was 7.2 months for Lonsurf with BSC vs 5.2 months for placebo with BSC, this translated into 1-year survival rates of 27.1% and 16.6%, respectively.

Comment: If approved in the EU, TAS 102 will face competition from many well-established products including 5-fluorouracil and oxaliplatin, as well as Bayer's Stivarga (regorafenib).