Officials with the FDA granted accelerated approval to polatuzumab vedotin-piiq (Polivy) in combination with bendamustine plus rituximab (Rituxan) (BR) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least 2 prior therapies, according to a press release.
With approximately 25,000 new cases expected to be diagnosed in 2019, DLBCL is the most common form of non-Hodgkin lymphoma. However, the disease can become more difficult to treat upon multiple relapses or no response to treatment, and as many as 40% of patients will relapse.
Polatuzumab vedotin-piiq is a first-in-class antibody-drug conjugate that specifically targets CD76b, a protein expressed in the majority of B-cells, according to Genentech.
Accelerated approval of the treatment was based on data from the phase 1b/2 GO29365 study. The trial included patients with relapsed or refractory DLBCL who are ineligible for a hematopoietic stem cell transplant.
According to Genentech, this is the first randomized clinical trial to demonstrate higher response rates over BR, which is commonly used in this patient population.
In the study, 40% of patients treated with polatuzumab vedotin-piiq plus BR achieved a complete response (n=16/40; 95% CI: 25-27) compared with 18% with BR alone (n=7/40; 95% CI: 7-33).
Other key findings included:
Forty-five percent of patients who received polatuzumab vedotin-piiq plus BR achieved an objective response at the end of treatment (n=18/40; 95% CI: 29-62) compared with 18% of those treated with BR alone (n=7/40; 95% CI: 7-33).
Of patients treated with polatuzumab vedotin-piiq plus BR who achieved a complete or partial response, 64% had a duration of response (DOR) lasting at least 6 months compared with 30% of patients treated with BR alone.
Forty-eight percent of patients treated with polatuzumab vedotin-piiq plus BR had a DOR lasting at least 1 year compared with 20% of patients treated with BR alone.
Adverse effects (AEs) occurred in at least 20% of patients and at least 5% more frequently in patients treated with polatuzumab vedotin-piiq plus BR compared with BR alone. AEs associated with polatuzumab vedotin-piiq plus BR included low white blood cell count, low platelet levels, low red blood cell count, numbness, tingling or pain in the hands and feet, diarrhea, fever, decreased appetite, and pneumonia.
“The approval of Polivy in combination with bendamustine and Rituxan offers patients with relapsed or refractory diffuse large B-cell lymphoma a new treatment option and new hope for improving patient outcomes,” Meghan Gutierrez, chief executive officer at the Lymphoma Research Foundation, said in a statement. “New medicines can transform the way health care providers approach this type of blood cancer and we commend those who contribute to accelerating research for the benefit of patients.”
The FDA previously granted Priority Review for the company Biologics License Application for polatuzumab vedotin-piiq plus BR in February 2019. The therapy was also granted Breakthrough Therapy Designation in 2017.
Polatuzumab vedotin-piiq plus BR is being developed by Roche using Seattle Genetics ADC technology. There is an ongoing study to confirm the clinical benefit of polatuzumab vedotin-piiq plus BR in DLBCL.
FDA Grants Genentech’s Polivy Accelerated Approval for People With Previously Treated Aggressive Lymphoma [news release]. Genentech. https://www.gene.com/media/press-releases/14795/2019-06-10/fda-grants-genentechs-polivy-accelerated
. June 10, 2019.