Research & Development
FDA Grants Genentech's Polivy Accelerated Approval for People with Previously Treated Aggressive Lymphoma
12 June 2019 - - The US Food and Drug Administration has granted accelerated approval to Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies, US-based biotechnology company Genentech said.
Genentech is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).
Accelerated approval was granted for this indication based on complete response rates observed in a randomized, controlled clinical trial. The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The accelerated approval of Polivy was based on the results from the Phase Ib/II GO29365 study.
This is the first and only randomized pivotal clinical trial to show higher response rates over BR, a commonly used regimen, in people with R/R DLBCL who are ineligible for a hematopoietic stem cell transplant.
Results of the study showed that 40% of people treated with Polivy plus BR achieved a complete response (n=16/40; 95 % CI:25-57), meaning no cancer could be detected at the time of assessment, compared to 18 % with BR alone (n=7/40; 95 % CI: 7-33).
Complete response rates were assessed by independent review committee. The study also showed that 45% of people on Polivy plus BR achieved an objective response at the end of treatment (n=18/40; 95% CI:29-62), compared to 18% of people treated with BR alone (n=7/40; 95% CI: 7-33).
Of the people treated with Polivy plus BR who achieved a complete or partial response, 64% (n=16/25) had a duration of response lasting at least six months as compared to 30% (n=3/10) of people treated with BR alone.
Additionally, 48% (n=12/25) of people treated with Polivy plus BR had a DOR lasting at least a year as compared to 20 % (n=2/10) of people treated with BR alone.
Adverse reactions occurring in at least 20 % of patients, and at least five % more frequently in patients treated with Polivy plus BR compared to BR alone, 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 FDA granted Priority Review for the company's Biologics License Application for Polivy in February 2019.
Priority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease.
In addition, Polivy was granted Breakthrough Therapy Designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of people with R/R DLBCL in 2017.
Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat a serious condition with preliminary evidence that indicates they may demonstrate substantial improvement over existing therapies.
GO29365 is a global, Phase Ib/II randomized study evaluating the safety, tolerability and activity of Polivy (polatuzumab vedotin-piiq) in combination with bendamustine and Rituxan (rituximab) or Gazyva (obinutuzumab) in relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma (DLBCL).
Eligible patients were not candidates for hematopoietic stem cell transplant at study entry. The Phase II part of the study randomized 80 patients with heavily pre-treated R/R DLBCL to receive either BR, or BR in combination with Polivy for a fixed duration of six 21-day cycles.
Patients enrolled had received a median of two prior therapies (a range of 1-7 prior therapies in the Polivy arm and range of 1-5 prior therapies in the BR alone arm).
The primary endpoint was complete response at the end of treatment, as measured by positron emission tomography and assessed by an independent review committee. Secondary endpoints included overall response rate (ORR; CR and partial response) by investigator assessment and best ORR at the end of treatment by investigator and IRC assessment.
Exploratory endpoints included duration of response, progression-free survival, event-free survival and overall survival.
Polivy is a first-in-class anti-CD79b antibody-drug conjugate. The CD79b protein is expressed specifically in the majority of B-cells, an immune cell impacted in some types of non-Hodgkin's lymphoma, making it a promising target for the development of new therapies.
Polivy binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Roche using Seattle Genetics ADC technology and is currently being investigated for the treatment of several types of NHL.
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin's lymphoma, accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL, which is generally responsive to treatment in the frontline.
However, as many as 40% of patients will relapse, at which time salvage therapy options are limited and survival is short. In the United States, it is estimated that nearly 25,000 new cases of DLBCL will be diagnosed in 2019.
Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have had at least two prior therapies.
The approval of Polivy is based on a type of response rate. There is an ongoing study to confirm the clinical benefit of Polivy.
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