FDA News

FDA approves Polivy regimen for diffuse large B-cell lymphoma

Sandra Horning, MD
Sandra Horning

The FDA granted accelerated approval to polatuzumab vedotin-piiq for use in combination with bendamustine plus a rituximab product for treatment of patients with relapsed or refractory diffuse large B-cell lymphoma who received at least two prior therapies.

This is the first FDA-approved chemoimmunotherapy regimen for this patient population.

Polatuzumab vedotin-piiq (Polivy, Genentech) is an antibody-drug conjugate that targets CD79b, a protein expressed in the majority of B cells, which are affected by certain types of non-Hodgkin lymphoma. The agent is being developed by Roche, using antibody-drug conjugate technology from Seattle Genetics.

“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.”

The FDA granted accelerated approval based on results from the 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.

The phase 2 portion of the study included 80 patients with relapsed or refractory DLBCL.

Researchers randomly assigned patients to bendamustine and rituximab alone (median prior therapies, 2; range, 1-5) or in combination with polatuzumab vedotin-piiq (median prior therapies, 2; range, 1-7) for six 21-day cycles.

Complete response at the end of treatment served as the primary endpoint. Secondary endpoints included overall response rate and best ORR at the end of treatment. Exploratory endpoints included duration of response, PFS, EFS and OS.

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%).

The most common adverse events among patients treated with polatuzumab vedotin-piiq include neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, fever, decreased appetite and pneumonia.

“The approval of Polivy in combination with bendamustine and [a rituximab product] offers patients with relapsed or refractory diffuse large B-cell lymphoma a new treatment option and new hope for improving patient outcomes,” Meghan Gutierrez, CEO of Lymphoma Research Foundation, said in the press release. “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 and breakthrough therapy designations to polatuzumab vedotin-piiq for this indication.

Sandra Horning, MD
Sandra Horning

The FDA granted accelerated approval to polatuzumab vedotin-piiq for use in combination with bendamustine plus a rituximab product for treatment of patients with relapsed or refractory diffuse large B-cell lymphoma who received at least two prior therapies.

This is the first FDA-approved chemoimmunotherapy regimen for this patient population.

Polatuzumab vedotin-piiq (Polivy, Genentech) is an antibody-drug conjugate that targets CD79b, a protein expressed in the majority of B cells, which are affected by certain types of non-Hodgkin lymphoma. The agent is being developed by Roche, using antibody-drug conjugate technology from Seattle Genetics.

“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.”

The FDA granted accelerated approval based on results from the 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.

The phase 2 portion of the study included 80 patients with relapsed or refractory DLBCL.

Researchers randomly assigned patients to bendamustine and rituximab alone (median prior therapies, 2; range, 1-5) or in combination with polatuzumab vedotin-piiq (median prior therapies, 2; range, 1-7) for six 21-day cycles.

Complete response at the end of treatment served as the primary endpoint. Secondary endpoints included overall response rate and best ORR at the end of treatment. Exploratory endpoints included duration of response, PFS, EFS and OS.

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%).

The most common adverse events among patients treated with polatuzumab vedotin-piiq include neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, fever, decreased appetite and pneumonia.

“The approval of Polivy in combination with bendamustine and [a rituximab product] offers patients with relapsed or refractory diffuse large B-cell lymphoma a new treatment option and new hope for improving patient outcomes,” Meghan Gutierrez, CEO of Lymphoma Research Foundation, said in the press release. “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 and breakthrough therapy designations to polatuzumab vedotin-piiq for this indication.