Phase III TAGS trial of Lonsurf in gastric cancer published in The Lancet Oncology.- Taiho Oncology.
Taiho Oncology announced the clinical data from the pivotal Phase III (TAGS) trial evaluating Lonsurf (trifluridine/tipiracil, TAS-102) versus placebo and best supportive care in patients with heavily pretreated metastatic gastric/gastroesophageal junction (GEJ) cancers who have progressed or are intolerant to previous lines of therapy were published in The Lancet Oncology. In the TAGS trial, patients treated with Lonsurf showed a clinically meaningful and statistically significant improvement in OS compared with placebo, a 31 percent risk reduction of death (HR 0.69 one sided p=0.00029), which translated into a prolongation of median survival of 2.1 months (5.7 months for trifluridine/tipiracil versus 3.6 months for placebo).
In addition, Lonsurf demonstrated a statistically significant improvement in PFS and time to deterioration of ECOG performance status versus placebo, as well as a predictable and manageable safety profile consistent with that previously reported in patients with metastatic colorectal cancer.
See: "Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase III trial." Kohei Shitara et al. The Lancet Oncology October 21, 2018DOI:https://doi.org/10.1016/S1470-2045(18)30739-3