LONSURF (trifluridine/tipiracil) - Colorectal cancer

The Committee deems that the clinical benefit of LONSURF in combination with bevacizumab is moderate in the restricted indication: patients with metastatic colorectal cancer (ECOG score 0-1) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, an anti-VEGF biologic therapy, and, in the event of a RAS wild type gene, an anti-EGFR agent. In the rest of the MA scope, the clinical benefit is insufficient to justify public funding. 

Considering:

• data from a comparative study having demonstrated a superiority of the bevacizumab/LONSURF combination versus LONSURF monotherapy in terms of overall survival and progression-free survival (difference in median of around 3 months for each of the endpoints),
• limitations with respect to interpretation of the results of this study due to the fact that more than a quarter of the patients (28%) in the comparator group had not been treated with bevacizumab during previous treatment lines, despite this already being recommended in clinical practice,
• the absence of data in the population with an ECOG score > 1,
• the impossibility of drawing a conclusion with respect to quality of life (exploratory endpoint),
• comparative data from the SUNLIGHT study showing a benefit of adding bevacizumab to LONSURF but, in no case, the contribution of the latter in this context,
• the absence of robust comparative data versus regorafenib, 

the Committee considers that, as the dossier currently stands, LONSURF in combination with bevacizumab provides no clinical added value (CAV V) in the current care pathway.