Phase III TAGS trial of Lonsurf meets primary endpoint in gastric cancer.- Taiho Oncology.
Taiho Oncology and Servier announced that the pivotal Phase III (TAGS) trial evaluating Lonsurf (trifluridine and tipiracil) plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer, met its primary endpoint of prolonged overall survival (OS). These results will be presented at an upcoming medical conference and will be submitted to a peer-reviewed journal for publication.
The TAGS (TAS-102 Gastric Study) trial is a Taiho-sponsored pivotal Phase III multinational, randomized, double-blind study evaluating Lonsurf also known as TAS-102, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. The primary endpoint in the TAGS trial is overall survival (OS), and secondary endpoint measures include progression-free survival (PFS), and safety and tolerability, as well as quality of life. The TAGS trial enrolled 507 adults 18 years and older with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The TAGS trial was conducted in Japan, North America, Europe, Russia and Turkey, among other locations.
The most common adverse drug reactions in Lonsurf-treated patients vs placebo-treated patients with refractory mCRC, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%).
Comment: Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with Ramucirumab), or irinotecan. The addition of trastuzumab to chemotherapy is standard of care for patients with HER2-neu-positive advanced gastric cancer. However, after failure of first- and second-line therapies, standard third line treatments are limited.
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