The preliminary findings of the extension arm of the phase 1b/2 GO29365 study confirmed the benefits and tolerability of polatuzumab vedotin plus bendamustine and rituximab for patients with diffuse large B-cell lymphoma.
After initial results from the phase 1b/2 GO29365 study (NCT02257567) led to the FDA approval of polatuzumab vedotin (Polivy) in combination with bendamustine and rituximab (Rituxan) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, an extension cohort of 106 patients was added to confirm efficacy and safety of the drug. Preliminary findings from that extension cohort were presented at this year’s 62nd Annual American Society of Hematology Meeting & Exposition.
In an interview with CancerNetwork®, Laurie H. Sehn, MD, of the British Columbia Cancer Centre for Lymphoid Cancer, discussed the key takeaways from those results.
I think the takeaway is that this extension cohort really does confirm the efficacy and overall safety of that combination. Keep in mind that this randomized phase 2 [trial] that enrolled 40 patients per arm really was the first randomized trial in this setting to demonstrate an overall survival advantage. Based on what is a modest-size trial, it earned that combination FDA approval and regulatory approval in many jurisdictions worldwide. The extension cohort was designed to add a larger number of patients to have greater confidence in terms of the benefit and safety of the combination. I think that it serves to illustrate the findings from the original randomization.