Note: The Cancer Letter has previously published information regarding this and can be found here.
Servier and Taiho Oncology Inc., said the safety and efficacy data in the gastrectomy patient subgroup of the global phase III trial TAGS evaluating Lonsurf (trifluridine/tipiracil, TAS-102) in patients with metastatic gastric cancer are consistent with the overall study results published in The Lancet Oncology. These data were highlighted in an oral presentation at the ASCO 2019 Gastrointestinal Cancers Symposium.
In TAGS, 221 (44%) of the 507 randomized mGC patients had undergone prior gastrectomy (147 LONSURF, 74 placebo), which is reflective of the real-world patient population diagnosed with mGC. The results confirmed that trifluridine/tipiracil prolonged survival versus placebo regardless of prior gastrectomy.
The overall results of TAGS demonstrated that patients treated with oral trifluridine/tipiracil showed a clinically meaningful and statistically significant improvement in overall survival compared with placebo and a 31 percent risk reduction of death (HR 0.69 one sided p=0.00029), which translated into a prolonged median survival of 2.1 months (5.7 months for trifluridine/tipiracil versus 3.6 months for placebo).
Trifluridine/tipiracil is indicated in E.U. for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan- based chemotherapies, anti-VEGF agents, and anti- EGFR agents.
Applications for an additional indication in mGC for LONSURF are under review by health authorities in Japan, the US and the EU.
TAS-102 Gastric Study is a Taiho-sponsored pivotal phase III, multinational, randomized, double-blind study evaluating trifluridine/tipiracil, also known as TAS-102, plus best supportive care versus placebo plus BSC in patients with metastatic gastric cancer, including gastroesophageal junction cancer, refractory to standard treatments.
The primary endpoint in the TAGS trial is OS, and the main secondary endpoint measures include progression-free survival, and safety and tolerability, as well as quality of life.
TAGS enrolled 507 adult patients with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The study was conducted in Belarus, the European Union, Israel, Japan, Russia, Turkey and the United States.
In Japan, Taiho Pharmaceutical Co., Ltd. has been marketing Lonsurf for the treatment of unresectable advanced or recurrent colorectal cancer since 2014. In the U.S., beginning in 2015, Taiho Oncology Inc., began marketing the drug for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
In June 2015, Taiho and Servier entered into an exclusive license agreement for the co-development and commercialization of Lonsurf in Europe and other countries outside of the US, Canada, Mexico and Asia.
