Phase III success for Takeda in lymphoma drug
pharmafile | August 1, 2016 | News story | Manufacturing and Production, Research and Development | Adcetris, Seattle Genetics, Takeda, lymphoma
Takeda Oncology and Seattle Generic have announced new Phase III data for trial drug, Adcetris (brentuximab vedotin), in patients with cutaneous T-cell lymphoma, which met its primary endpoint of statistically significant objective response rates.
Seattle Genetics and Takeda are jointly developing Adcetris, with Seattle retaining US and Canadian commercialisation rights to the drug, with the rights for the rest of the world granted to the Japanese drugmaker. The treatment has been approved in the US for two forms of lymphoma while it also recently received an EU marketing authorisation to treat CD30+ Hodgkin lymphoma.
The Phase III ALCANZA trial compared the use of Adcetris monotherapy versus investigator’s choice of standard therapies, such as methotrexate or bexaratone, in 131 patients with CD-30-expressing cutaneous T-cell lymphoma who received prior systemic or radiation therapy.
The data shows that treatment with Adectris significantly improved objective response rate lasting at least for four months (ORR4). In this treatment arm, ORR4 was 56.3% compared to 12.5% in the control arm. Similarly, secondary endpoints including complete response rate, progression-free survival and reduction in the burden of symptoms during treatment, were all higher in the Adcetris arm.
Dirk Huebner, executive medical director in oncology at Takeda, says: “These remarkable, clinically meaningful results from the completed ALCANZA trial represent an important milestone for the Adcetris program. If this new indication is approved by regulatory authorities, Adcetris may offer a novel treatment option for cutaneous T-cell lymphoma patients.”
Seattle Genetics chief executive, Clay Siegall, adds: “We anticipate reporting more complete ALCANZA data at the American Society of Hematology annual meeting in December and intend to submit a supplemental Biologics License Application to the FDA in the first half of 2017 for approval in this setting.”
Sean Murray
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