Polatuzumab vedotin combined with bendamustine and rituximab demonstrated encouraging rates of complete response among patients with transplantation-ineligible, relapsed/refractory diffuse large B-cell lymphoma, according to results of a phase 1b/phase 2 trial published in Journal of Clinical Oncology.
The combination also reduced the risk for death by more than half compared with bendamustine and rituximab alone, results showed.
“Patients with relapsed/refractory DLBCL who are transplant ineligible have remarkably poor outcomes with limited treatment options. There is a great need to develop novel agents in this setting to enable prolonged disease control with minimal toxicity,” Laurie H. Sehn, MD, MPH, chair of the lymphoma tumor group at British Columbia Cancer Agency and clinical assistant professor in the division of medical oncology at University of British Columbia, told HemOnc Today. Sehn and colleagues sought to assess the use of polatuzumab vedotin (Polivy, Genentech), which targets the B-cell receptor component, among this patient population, for which limited treatment options exist.
The FDA granted accelerated approval based on results from this phase 1B/phase 2 GO29365 study, which evaluated the activity, safety and tolerability of polatuzumab vedotin-piiq in combination with bendamustine plus a rituximab product or obinutuzumab (Gazyva, Genentech) for patients with relapsed or refractory DLBCL or follicular lymphoma who were not candidates for hematopoietic stem cell transplant.
“Despite meaningful progress in the treatment of diffuse large B-cell lymphoma, treatment options are very limited when the disease is refractory to or recurrent after multiple regimens,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “[The] approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease.”
Results showed a higher percentage of patients assigned polatuzumab vedotin-piiq achieved complete response (40% vs. 18%) and objective response at the end of treatment (45% vs. 18%).
Among patients who achieved complete or partial response, those assigned polatuzumab vedotin-piiq were more than twice as likely as those assigned bendamustine-rituximab alone to maintain their response for at least 6 months (64% vs. 30%) or at least 12 months (48% vs. 20%).