Laurie H. Sehn, MD, MPH, Discusses the Extension Arm of the Phase 2 GO29365 Trial in DLBCL

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.

Transcription:

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.