— Diffuse large B-cell lymphoma is an aggressive type of blood cancer that typically becomes harder to treat each time it returns —
— Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease —
SOUTH SAN FRANCISCO, CA, USA I February 19, 2019 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by August 19, 2019.
“Polatuzumab vedotin, a potential first-in-class antibody drug conjugate, in combination with bendamustine and Rituxan, improved clinical outcomes including survival in some people with relapsed or refractory diffuse large B-cell lymphoma compared to bendamustine and Rituxan alone,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are working with the FDA to bring this important new option to patients with this aggressive disease as quickly as possible.”
The BLA is based on results of the GO29365 study, which showed that polatuzumab vedotin plus BR improved median overall survival compared to BR alone (12.4 vs. 4.7 months, HR=0.42; 95 percent CI 0.24-0.75; exploratory endpoint), in people with R/R DLBCL not eligible for a hematopoietic stem cell transplant. The study also showed that 40 percent of people treated with polatuzumab vedotin plus BR achieved a complete response (CR), while only 18 percent of people treated with BR alone achieved a CR (primary endpoint, as measured by positron emission tomography; CR rates assessed by independent review committee). A CR means no cancer could be detected at that time.
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. Polatuzumab vedotin was also 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.
About the GO29365 study
GO29365 is a global, Phase Ib/II randomized study evaluating the safety, tolerability and activity of polatuzumab vedotin in combination with bendamustine and Rituxan (rituximab) or Gazyva® (obinutuzumab) in relapsed or refractory (R/R) follicular lymphoma or diffuse large B-cell lymphoma (DLBCL). The Phase II stage randomized 80 patients with heavily pre-treated R/R DLBCL to receive either bendamustine plus Rituxan (BR), or BR in combination with polatuzumab vedotin. Patients enrolled had received a median of two prior therapies (a range of 1-7 prior therapies in the polatuzumab vedotin arm and range of 1-5 prior therapies in the BR alone arm). The primary endpoint was complete response (CR) at the end of treatment, as measured by positron emission tomography (PET) and assessed by an independent review committee (IRC). Secondary endpoints included objective response (OR; CR and partial response, PR) by investigator assessment and best objective response at the end of treatment by investigator and IRC assessment. Exploratory endpoints included duration of response (DOR), progression-free survival (PFS), event-free survival (EFS) and overall survival (OS).
- 40 percent of people treated with polatuzumab vedotin plus BR achieved a CR while only 18 percent of people treated with BR alone achieved a CR (primary endpoint, as measured by PET; CR rates assessed by IRC). A CR means no cancer could be detected at that time.
- Polatuzumab vedotin in combination with BR showed a median OS of over one year compared to the BR arm (12.4 vs. 4.7 months, HR=0.42; 95 percent CI 0.24-0.75), in people with R/R DLBCL not eligible for a hematopoietic stem cell transplant. OS was an exploratory endpoint.
- Polatuzumab vedotin plus BR increased median PFS and led to a 66 percent reduction in risk of disease worsening or death compared to BR alone (median PFS: 7.6 months vs. 2.0 months; HR=0.34; 95 percent CI 0.20-0.57).
- Patients treated with polatuzumab vedotin plus BR showed a longer time between first response to treatment and disease worsening than those receiving BR alone (investigator assessed median DOR: 10.3 months vs. 4.1 months; HR=0.44).
- Updated safety results are similar to those previously described, with infections and cytopenias remaining the most common Grade 3–4 adverse events (AEs). Polatuzumab vedotin plus BR had higher rates of Grade 3–4 cytopenias compared to BR, however, infection and transfusion rates remained similar between arms.
About polatuzumab vedotin
Polatuzumab vedotin is a first-in-class anti-CD79b antibody drug conjugate (ADC) currently being investigated for the treatment of several types of non-Hodgkin’s lymphoma (NHL). The CD79b protein is highly specific and expressed in the majority of types of B-cell NHL, making it a promising target for the development of new therapies. Polatuzumab vedotin binds to CD79b and destroys these B-cells through a targeted approach, which is thought to minimize the effects on normal cells while maximizing tumor cell death. Polatuzumab vedotin is being developed by Genentech utilizing Seattle Genetics ADC technology.
About DLBCL
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL. As many as 40 percent of patients will relapse, at which point their prognosis is poor. In the United States, it is estimated that more than 22,000 new cases of DLBCL will be diagnosed in 2019.
Rituxan Indications
Rituxan® (rituximab) injection, for intravenous use, is indicated for the treatment of:
- Low-grade or follicular CD20-positive non-Hodgkin’s lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
- Follicular CD20-positive non-Hodgkin’s lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy
- Low-grade CD20-positive non-Hodgkin’s lymphoma as a single-agent follow-up therapy for patients who did not progress on initial treatment with CVP chemotherapy
- CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma as an initial treatment in combination with CHOP chemotherapy
- CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred
It is not known if Rituxan is safe and effective in children.
About Genentech in Hematology
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
Post Views: 106
— Diffuse large B-cell lymphoma is an aggressive type of blood cancer that typically becomes harder to treat each time it returns —
— Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease —
SOUTH SAN FRANCISCO, CA, USA I February 19, 2019 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for polatuzumab vedotin in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by August 19, 2019.
“Polatuzumab vedotin, a potential first-in-class antibody drug conjugate, in combination with bendamustine and Rituxan, improved clinical outcomes including survival in some people with relapsed or refractory diffuse large B-cell lymphoma compared to bendamustine and Rituxan alone,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are working with the FDA to bring this important new option to patients with this aggressive disease as quickly as possible.”
The BLA is based on results of the GO29365 study, which showed that polatuzumab vedotin plus BR improved median overall survival compared to BR alone (12.4 vs. 4.7 months, HR=0.42; 95 percent CI 0.24-0.75; exploratory endpoint), in people with R/R DLBCL not eligible for a hematopoietic stem cell transplant. The study also showed that 40 percent of people treated with polatuzumab vedotin plus BR achieved a complete response (CR), while only 18 percent of people treated with BR alone achieved a CR (primary endpoint, as measured by positron emission tomography; CR rates assessed by independent review committee). A CR means no cancer could be detected at that time.
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. Polatuzumab vedotin was also 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.
About the GO29365 study
GO29365 is a global, Phase Ib/II randomized study evaluating the safety, tolerability and activity of polatuzumab vedotin in combination with bendamustine and Rituxan (rituximab) or Gazyva® (obinutuzumab) in relapsed or refractory (R/R) follicular lymphoma or diffuse large B-cell lymphoma (DLBCL). The Phase II stage randomized 80 patients with heavily pre-treated R/R DLBCL to receive either bendamustine plus Rituxan (BR), or BR in combination with polatuzumab vedotin. Patients enrolled had received a median of two prior therapies (a range of 1-7 prior therapies in the polatuzumab vedotin arm and range of 1-5 prior therapies in the BR alone arm). The primary endpoint was complete response (CR) at the end of treatment, as measured by positron emission tomography (PET) and assessed by an independent review committee (IRC). Secondary endpoints included objective response (OR; CR and partial response, PR) by investigator assessment and best objective response at the end of treatment by investigator and IRC assessment. Exploratory endpoints included duration of response (DOR), progression-free survival (PFS), event-free survival (EFS) and overall survival (OS).
- 40 percent of people treated with polatuzumab vedotin plus BR achieved a CR while only 18 percent of people treated with BR alone achieved a CR (primary endpoint, as measured by PET; CR rates assessed by IRC). A CR means no cancer could be detected at that time.
- Polatuzumab vedotin in combination with BR showed a median OS of over one year compared to the BR arm (12.4 vs. 4.7 months, HR=0.42; 95 percent CI 0.24-0.75), in people with R/R DLBCL not eligible for a hematopoietic stem cell transplant. OS was an exploratory endpoint.
- Polatuzumab vedotin plus BR increased median PFS and led to a 66 percent reduction in risk of disease worsening or death compared to BR alone (median PFS: 7.6 months vs. 2.0 months; HR=0.34; 95 percent CI 0.20-0.57).
- Patients treated with polatuzumab vedotin plus BR showed a longer time between first response to treatment and disease worsening than those receiving BR alone (investigator assessed median DOR: 10.3 months vs. 4.1 months; HR=0.44).
- Updated safety results are similar to those previously described, with infections and cytopenias remaining the most common Grade 3–4 adverse events (AEs). Polatuzumab vedotin plus BR had higher rates of Grade 3–4 cytopenias compared to BR, however, infection and transfusion rates remained similar between arms.
About polatuzumab vedotin
Polatuzumab vedotin is a first-in-class anti-CD79b antibody drug conjugate (ADC) currently being investigated for the treatment of several types of non-Hodgkin’s lymphoma (NHL). The CD79b protein is highly specific and expressed in the majority of types of B-cell NHL, making it a promising target for the development of new therapies. Polatuzumab vedotin binds to CD79b and destroys these B-cells through a targeted approach, which is thought to minimize the effects on normal cells while maximizing tumor cell death. Polatuzumab vedotin is being developed by Genentech utilizing Seattle Genetics ADC technology.
About DLBCL
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin’s lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL. As many as 40 percent of patients will relapse, at which point their prognosis is poor. In the United States, it is estimated that more than 22,000 new cases of DLBCL will be diagnosed in 2019.
Rituxan Indications
Rituxan® (rituximab) injection, for intravenous use, is indicated for the treatment of:
- Low-grade or follicular CD20-positive non-Hodgkin’s lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
- Follicular CD20-positive non-Hodgkin’s lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy
- Low-grade CD20-positive non-Hodgkin’s lymphoma as a single-agent follow-up therapy for patients who did not progress on initial treatment with CVP chemotherapy
- CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma as an initial treatment in combination with CHOP chemotherapy
- CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred
It is not known if Rituxan is safe and effective in children.
About Genentech in Hematology
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
Post Views: 106
