Study success sets up potential eighth indication for Pfizer, Takeda’s Adcetris
12 Mar 2024
Clinical ResultPhase 3ADCAcquisitionImmunotherapy
Pfizer and Takeda are one step closer to adding an eighth approved indication to Adcetris (brentuximab vedotin) in the US following a positive late-stage study read-out for the CD30-targeted antibody-drug conjugate.
The companies said Tuesday that the ECHELON-3 trial of Adcetris in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo plus lenalidomide and rituximab. Positive outcomes were also seen for key secondary endpoints, including progression-free survival and overall response rate.
“This is the third Phase III study in a type of lymphoma to demonstrate an overall survival benefit for an Adcetris combination,” remarked Roger Dansey, Pfizer’s oncology chief development officer. He added “the results are particularly encouraging because the study evaluated heavily pre-treated patients, including some who received prior CAR-T therapy.”
Pfizer indicated that it will share the ECHELON-3 data with the FDA, while full results will be submitted for presentation at an upcoming medical meeting.
The news comes shortly after Pfizer detailed its lofty aspirations in oncology and also serves as further validation of the recent $43-billion acquisition of Seagen, through which it gained Adcetris. Meanwhile, the drugmaker’s bullish stance contrasts with an update from Seagen late last year in which it decided that ECHELON-3 would “no longer be considered registrational,” without providing further details.
More come.
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