Taiho's Lonsurf meets OS endpoint in Phase III for gastric cancer

Taiho Pharmaceutical Co. Ltd. (Tokyo, Japan) and partner Servier (Suresnes, France) said Lonsurf trifluridine/tipiracil as third-line treatment met the primary endpoint of improving overall survival (OS) vs. placebo in the Phase III TAGS trial to treat metastatic gastric cancer. Taiho said it plans to submit "as soon as possible" an sNDA to FDA for Lonsurf in the indication.

The double-blind, international trial enrolled 507 metastatic gastric cancer patients who previously received at least two prior regimens to receive best supportive care (BSC) plus placebo or twice-daily 35 mg/m² oral Lonsurf on days 1-5 and 8-12 of each 28-day cycle. Data will be presented at an upcoming medical meeting...