Takeda releases interim Phase III data supporting long-term efficacy of vedolizumab

Vedolizumab is a gut-selective humanized monoclonal antibody that has recently been made available in the US and the EU, and also approved in Australia under the trade name Entyvio.

Two of the abstracts show that the efficacy observed in vedolizumab Phase III induction and maintenance trials of 52 weeks was maintained over the course of an additional 52 weeks of open label follow up.

Data from this trial will be presented during the 21st United European Gastroenterology Week (UEGW) in Vienna, Austria.

GEMINI LTS will enroll patients who completed or withdrew early from the double-blind, randomized, placebo-controlled maintenance trials GEMINI 1 and 2.

The company said that patients included in the Efficacy Population (GEMINI completers) were given vedolizumab 300mg IV doses every four weeks (Q4W).

Of the UC patients who completed GEMINI 1 and enrolled in GEMINI LTS, 66% were in clinical remission at week 52 and 73% were in clinical remission at week 104.

Additionally, 79% had clinical response at week 52 and 80% had clinical response at week 104.

Takeda Pharmaceuticals vice-president Global Medical head, General Medicine Michael Smyth said the company is focused on the ongoing study of vedolizumab for ulcerative colitis and Crohn’s disease, with a goal of continuing to identify how we can further support the patient and professional communities.

"It is therefore encouraging to see initial data from the ongoing long-term extension study that explores the possible utility of vedolizumab Q4W dosing for some patients," Smyth said.

Image: Takeda Midosuji Building, headquarters of Takeda Pharmaceutical Company, in Chuo-ku, Osaka, Japan. Photo: courtesy of J o.