The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending trifluridine/tipiracil, within its marketing authorisation, as an option for treating metastatic colorectal cancer, in adults who have had previous treatment with available therapies including fluoropyrimidine‐, oxaliplatin‐ or irinotecan‐based chemotherapies, anti‐vascular endothelial growth factor (VEGF) agents and anti‐epidermal growth factor receptor (EGFR) agents, or when these therapies are not suitable.

The full recommendation can be found here.

Trifluridine/tipiracil is avialable under the brand name of Lonsurf, from Servier

The decision by NICE arrives four months after the European Commission granted trifluridine/tipiracil a Marketing Authorisation.

Dr Rob Glynne‐Jones, Consultant Oncologist and Macmillan Lead Clinician in Gastrointestinal Cancer at the Mount Vernon Cancer Centre said “There are not many options left when a patient has had previous treatments. [Trifluridine/tipiracil] is potentially a valuable new drug that I can offer to my patients with metastatic colorectal cancer regardless of their RAS status or resistance to previous lines of treatment. It’s great news that NICE has recommended [it] ‐ because I now have a treatment that could give my patients some extra time”

The NICE committee took end‐of‐life considerations into account, agreeing that trifluridine/tipiracil met the criterion for extending life.

NICE therefore appraised the survival benefit with trifluridine/tipiracil in the context of the life expectancy of patients with metastatic colorectal cancer, and concluded that as a third‐ or subsequent‐line treatment for metastatic colorectal cancer, trifluridine/tipiracil represents a well‐tolerated treatment that would help extend life by even a relatively short time, while maintaining a reasonably good quality of life at a late stage in the treatment pathway when there are no further options left.

In coming to their decision, the NICE appraisal committee considered evidence 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.

The trial met the primary endpoint of a statistically significant improvement in overall survival (OS).

The median OS improved from 5.2 months with placebo ( BSC) to 7.2 months with trifluridine/tipiracil ( BSC).

The hazard ratio for death in the trifluridine/tipiracil group versus the placebo group was 0.69 (95% confidence interval [CI], 0.59 to 0.81; P<0.0001), this translated into 1‐year survival rates of 27.1% and 16.6%, respectively.

The most frequently observed side effects (≥ 30%) in patients receiving trifluridine/tipiracil were neutropenia, nausea, decreased appetite, diarrhoea, fatigue, anaemia, thrombocytopenia, increase in total bilirubin, alkaline phosphatase and AST levels, and leucopenia.

Following publication of NICE guidance recommending the use of a treatment, NHS Trusts in England have 90 days to ensure funding is available at a local level and eligible patients have access to treatment.

As trifluridine/tipiracil has been recommended by NICE and given that Servier is participating in the industry agreement with the Cancer Drugs Fund, trifluridine/tipiracil will be funded immediately thereby avoiding any delays in appropriate patients receiving this new treatment.

Source: NICE