Taiho Oncology has reported positive results from its Phase III TAS-102 gastric study (TAGS) trial.
The trial examined Lonsurf (trifluridine / tipiracil, TAS-102) plus best supportive care (BSC) in comparison with placebo plus BSC for the treatment of patients with metastatic gastric cancer, including metastatic gastric / gastroesophageal junction (GEJ) cancer, refractory to standard treatments.
Results showed that the trial met its primary endpoint of prolonged overall survival (OS), and secondary endpoint measures of progression-free survival (PFS). They also demonstrated Lonsurf’s predictable safety and tolerability profile.
During the TAGS trial, patients receiving Lonsurf showed a clinically meaningful and statistically significant improvement in OS compared with placebo. The results showed a 31% reduction in the risk of death, or a prolongation of median survival of 2.1 months.
Lonsurf also showed a statistically significant improvement in PFS and time to deterioration of Eastern Cooperative Oncology Group (ECOG) performance status against placebo, among others.
Taiho Oncology senior vice-president and chief medical officer Martin Birkhofer said: “These results further expand the proven clinical benefit of Lonsurf beyond metastatic colorectal cancer patients, to include metastatic gastric and GEJ cancer patients.
“This represents a significant milestone in our efforts to expand the body of evidence for trifluridine/tipiracil in the treatment of GI cancers.”
A total of 507 adult patients with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease were included in the randomised, double-blind trial.
It was carried out in Japan, the US, the EU, Russia, Belarus, Israel, and Turkey.
An oral anticancer drug, Lonsurf is currently under development by a partnership of Taiho Pharmaceutical and Servier as part of an exclusive licence agreement.
Under the agreement, Taiho Pharmaceutical and Servier have the right to commercialise Lonsurf in Europe and other countries outside of the US, Canada, Mexico, and Asia.
The drug has been approved as a treatment for advanced mCRC in 54 countries.