Efficacy of TAS-102 Continues to Hold Up in Metastatic CRC and Gastric Cancers

Howard S. Hochester, MD, associate director for clinical research at the Rutgers Cancer Institute of New Jersey, discusses findings from the pooled safety analysis of TAS-102 (trifluridine/tipiracil; Lonsurf) in previously treated patients with colorectal cancer (CRC) and gastric/gastroesophageal junction (GEJ) adenocarcinoma.

TAS-102 was previously approved by the FDA in 2015 for the treatment of patients with metastatic CRC based on data from the phase III RECOURSE trial. Data from the RECOURSE trial demonstrated a median overall survival (OS) of 7.1 months in patients who received TAS-102 compared with 5.3 months with placebo. The median progression-free survival was also improved with TAS-102 compared with placebo, 2 versus 1.7 months, respectively. The approval in metastatic CRC includes patients who were previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and an anti-VEGF biologic product; if the patient is RAS wild-type, they must have also received a prior anti-EGFR monoclonal agent.

TAS-102 was later approved in 2019 for patients with metastatic gastric/GEJ adenocarcinoma following prior treatment with at least 2 chemotherapy regimens, including a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2-targeted therapy. This approval was based on findings from the phase III TAGS trial, in which the median OS was improved at 5.7 months with TAS-102 versus 3.6 months with placebo. The median PFS in this trial was also 2 months with TAS-102 compared with 1.8 months with placebo.

In both patient populations, TAS-102 led to a survival benefit for patients who had received 1 or 2 prior regimens, Hochster says.