Taiho Oncology Inc. and Servier announced clinical data from the pivotal phase III trial (TAGS) evaluating Lonsurf (trifluridine and tipiracil, TAS-102) plus best supportive care versus placebo plus BSC in patients with previously treated metastatic gastric cancer refractory to standard therapies.
This trial met its primary endpoint of overall survival and secondary endpoint measures of progression-free survival, and safety and tolerability, as well as quality of life. The data were presented as oral and poster presentations at the ESMO 20th World Congress on Gastrointestinal Cancer 2018 in Barcelona, June 20 to 23.
In the TAGS trial, patients treated with Lonsurf had a 31 percent risk reduction of death and a prolongation of their median survival by 2.1 months when compared with placebo (OS of 5.7 months compared to 3.6 months in the placebo group (hazard ratio [HR]: 0.69; 95 percent confidence interval 0.56, 0.85; one-sided p=0.0003); at 12-months, OS rates were 21.2 percent in the Lonsurf group and 13.0 percent in the placebo group. In addition, the risk for disease progression as measured by PFS, a key secondary endpoint, was reduced by 43 percent (HR: 0.57).
Any Grade 3 or higher adverse events (AEs) occurred in 80 percent of treated patients who received Lonsurf and in 58 percent of treated patients who received placebo. Grade 3/4 hematological AEs in patients treated with trifluridine and tipiracil included neutropenia (38 percent), leucopenia (21 percent), anemia (19 percent) and lymphocytopenia (19 percent). Of the 38 percent of patients who experienced grade 3/4 neutropenia when treated with Lonsurf, six (2 percent) experienced febrile neutropenia. No new safety signals were observed for Lonsurf in the TAGS study.
“We intend to include these data in an sNDA submission to FDA for consideration as a third-line treatment option for appropriate patients with metastatic gastric cancer,” said Martin Birkhofer, senior vice president and chief medical officer of Taiho Oncology.
Lonsurf is currently indicated in the United States for the treatment of patients with metastatic colorectal cancer 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.
