The ongoing GO29365 study of combination regimens containing polatuzumab vedotin (Polivy) for patients with relapsed or refractory diffuse large B-cell lymphoma added an additional 106 patients to confirm preliminary findings of safety and efficacy.
Initial findings from the randomized cohort of GO29365 (NCT02257567), a phase 1b/2 study that examined polatuzamab vedotin (Polivy) plus bendamustine (Bendeka) and rituximab (Rituxan; BR) versus BR alone for patients with relapsed or refractory diffuse large B-cell lymphoma, led to the FDA granting accelerated approval to the antibody-drug conjugate in June 2019. Results from that study showed improved progression-free survival and overall survival for patients in the polatuzumab arm.
In an interview with CancerNetwork®, Laurie H. Sehn, MD, MPH, of the BC Cancer Centre for Lymphoid Cancers, talked about the rationale behind amending the GO29365 study to include an additional extension cohort.
The study that was presented was an update of the [trial comparing] polatuzumab vedotin [Polivy] and bendamustine/rituximab [BR] combination versus BR alone. This was a randomized phase 2 trial that documented the effectiveness of polatuzumab vedotin. But in addition to a follow-up of the original randomized phase 2, we also presented data on an extension cohort of an additional 106 patients who were treated with that combination.
So, the original trial was a randomized phase 2 trial and rolled 40 patients in each arm, so it included 40 patients treated with [polatuzumab vedotin and BR]. The extension arm was really designed to further evaluate the merit of that combination by adding an additional 106 patients.