Servier announced that the European Commission has granted a Marketing Authorisation for LONSURF® (trifluridine/tipiracil), formerly known as TAS‐102, in the European Union (EU) 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.1 This follows the positive opinion received by the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) in February 2016, which recommended the licensing of trifluridine/tipiracil for the treatment of adult patients with metastatic colorectal cancer (mCRC).3
The Marketing Authorisation is based on data from the international, double‐blind, placebo‐controlled Phase III RECOURSE study, which investigated the efficacy and safety of trifluridine/tipiracil plus best supportive care (BSC) compared to placebo plus BSC in 800 patients with previously treated mCRC.2 The trial met the primary endpoint of a statistically significant improvement in overall survival (OS).2
The median OS improved from 5.3 months with placebo to 7.1 months with trifluridine/tipiracil, an improvement of 1.8 months.2 The hazard ratio for death in the trifluridine/tipiracil group versus the placebo group was 0.68 (95% confidence interval [CI], 0.58 to 0.81; P2 The most frequently observed side effects (≥ 30%) in patients receiving trifluridine/tipiracil were neutropenia, nausea, fatigue, anaemia and leucopenia.2
Dr Mark Saunders, lead Consultant Clinical Oncologist at The Christie's Colorectal and Peritoneal Oncology Centre said "From my own limited use of this product, and from the clinical trials, Lonsurf appears to be generally well tolerated and to extend the lives of patients with refractory metastatic colorectal cancer.
Lonsurf's mechanism of action means that it is effective in patients regardless of their RAS status or resistance to previous treatments. This could be a valuable new drug and could give my patients some precious extra time."
An updated analysis of OS was carried out on the RECOURSE population and was presented at the American Society of Clinical Oncology - Gastro Intestinal (ASCO GI) 2016 congress.4 As the updated analysis was conducted at a later time point, it included additional events; 89% of the study population had died at this point compared to 72% at the time of the original analysis.2,4 The results confirmed the clinically meaningful and, statistically significant, survival benefit of trifluridine/tipiracil, providing patients who have exhausted the other treatment options available to them with an improvement of around 2 months in OS (median).4
The median OS was 7.2 months for trifluridine/tipiracil (+BSC) vs 5.2 months for placebo (+ BSC) (HR=0.69; 95% CI: 0.59 to 0.81; p4
Trifluridine/tipiracil is now licensed for use in the 28 member countries of the European Union (EU), as well as Iceland, Lichtenstein and Norway.1 Availability and funding of trifluridine/tipiracil for patients via the NHS is dependent upon a review by the relevant national Health Technology Appraisal bodies, which is expected to conclude later this year.