Takeda to seek Japan approval for gastric cancer drug next year
TAK•Takeda plans to seek Japanese approval next year for arcotatug tavatecan after a late-stage trial showed longer overall survival and delayed disease progression in advanced gastric cancer. Median survival was 10.2 months with the drug versus 6.9 months with chemotherapy among 464 patients.
1. Trial results
Arcotatug tavatecan met both primary goals in a late-stage study of patients with advanced gastric or gastroesophageal junction cancer who had received at least two prior therapies. Median progression-free survival was 7.1 months with the drug versus 3.1 months with chemotherapy, based on an independent review.
2. Safety and next steps
Serious side effects occurred in about 47% of patients taking the drug, compared with about 56% of those on chemotherapy. One patient died suddenly from an unknown cause linked to treatment. Takeda oncology development head PK Morrow said the company plans to file a new drug application in Japan next year. The drug targets claudin 18.2 and was licensed from Innovent, which holds the rights in China.
