– Phase III VIALE-A study showed Venclexta plus azacitidine helped people with the most common type of aggressive adult leukemia live longer compared to azacitidine alone –
– Data will be presented as a late-breaking abstract at the 25th European Hematology Association Virtual Congress –
SOUTH SAN FRANCISCO, CA, USA I June 13, 2020 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III VIALE-A study, evaluating Venclexta® (venetoclax) in combination with azacitidine in people with previously untreated acute myeloid leukemia (AML) who were ineligible for intensive induction chemotherapy. VIALE-A results were featured in the 25th European Hematology Association Virtual Congress Press Briefing on Saturday, June 13, 2020 at 8:30 AM CEST and will be presented at the congress during the Late-breaking Oral Session (abstract #LB2601) on Sunday, June 14, 2020.
“We are very pleased to present these important results from people with acute myeloid leukemia, especially those who are unable to tolerate intensive chemotherapy and therefore have limited treatment options,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The significant survival benefits observed in the VIALE-A study reinforce the potential utility of this Venclexta-based combination for people with this aggressive disease.”
Results from the VIALE-A study showed that the Venclexta combination reduced the risk of death (overall survival [OS]) by 34% compared to azacitidine alone (median OS=14.7 months vs. 9.6 months; HR: 0.66, 95% CI: 0.52–0.85, p<0.001) in people with previously untreated AML. The Venclexta plus azacitidine combination also led to higher rates of composite complete remission (CR + CR with incomplete blood count recovery [CR + CRi]) at 66.4% compared to 28.3% with azacitidine alone (p<0.001).
Safety for Venclexta plus azacitidine appeared consistent with the known safety profile of these medicines and no unexpected safety signals were identified with the combination. Notable Grade 3 or higher adverse events in the Venclexta plus azacitidine and azacitidine alone arms included low platelet count (thrombocytopenia; 45% vs. 38%), low white blood cell count (neutropenia; 42% vs. 29%; leukopenia; 21% vs. 12%), low white blood cell count with fever (febrile neutropenia; 42% vs. 19%) and low red blood cell count (anemia; 26% vs. 20%).
The study also met its secondary endpoint of CR and CR with partial hematologic recovery (CR + CRh), with the combination showing a CR + CRh of 64.7% compared to 22.8% with azacitidine alone.
Data from the VIALE-A study has been shared with health authorities globally including the U.S. Food and Drug Administration (FDA). Venclexta has previously been granted accelerated approval by the FDA in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of people with newly diagnosed AML who are aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. VIALE-A is part of Venclexta’s ongoing development program to convert the current accelerated approval of Venclexta, granted by the FDA in previously untreated AML, to a full approval. Venclexta has also been granted five Breakthrough Therapy Designations by the FDA, including two for previously untreated AML.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.
About the VIALE-A Study
VIALE-A (NCT02993523) is a Phase III, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of Venclexta® (venetoclax) plus azacitidine, a hypomethylating agent, compared to placebo plus azacitidine, in 433 people with previously untreated acute myeloid leukemia who are ineligible for intensive chemotherapy. Two-thirds of patients received 400 mg Venclexta daily, in combination with azacitidine, and the remaining patients received placebo tablets in combination with azacitidine. Patients enrolled in the study had a range of mutational subtypes, including IDH1/2 and FLT3. The primary endpoints of the study are overall survival (OS) and rate of complete remission (CR) and CR with incomplete blood count recovery (CRi). OS was the sole primary endpoint in the United States (U.S.) and U.S. reference countries, and OS and CR + CRi were co-primary endpoints in China, Japan, the European Union (EU) and EU reference countries. Secondary endpoints include CR and CR with partial hematologic recovery (CRh), event-free survival, transfusion independence and patient-reported outcomes.
| |
Venclexta plus azacitidine
(n=286) |
Azacitidine plus placebo
(n=145) |
| |
| Median OS |
14.7 months |
9.6 months |
| Hazard ratio: 0.66, 95% CI: 0.52–0.85, p<0.001 |
| CR + CRi |
66.4% |
28.3% |
| p<0.001 |
| |
| CR + CRh |
64.7% |
22.8% |
| p<0.001 |
| CR + CRi rates in molecular subgroups |
|
| IDH1/2 |
75% |
11% |
| p<0.001 |
| FLT3 |
72% |
36% |
| p=0.021 |
| NPM1 |
67% |
24% |
| p=0.012 |
| TP53 |
55% |
0% |
| p<0.001 |
About AML
Acute myeloid leukemia (AML) is the most common type of aggressive leukemia in adults, which has the lowest survival rate for all types of leukemia. In 2020, it is estimated there will be nearly 20,000 new cases of AML diagnosed in the United States. Many AML patients older than age 60 are unable to tolerate intensive induction chemotherapy treatment.
About Venclexta
Venclexta is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood and other cancers.
In the United States, Venclexta has been granted five Breakthrough Therapy Designations by the U.S. Food and Drug Administration: one for previously untreated chronic lymphocytic leukemia (CLL), two for relapsed or refractory CLL and two for previously untreated acute myeloid leukemia.
Venclexta Indications
Venclexta is a prescription medicine used:
- To treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- In combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
‒ Are 75 years of age or older, or
‒ Have other medical conditions that prevent the use of standard chemotherapy.
‒ Venclexta was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how Venclexta works over a longer period of time.
It is not known if Venclexta is safe and effective in children.
Please visit http://www.Venclexta.com for the Venclexta full Prescribing Information, including Patient Information, for additional Important Safety Information.
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: 23
– Phase III VIALE-A study showed Venclexta plus azacitidine helped people with the most common type of aggressive adult leukemia live longer compared to azacitidine alone –
– Data will be presented as a late-breaking abstract at the 25th European Hematology Association Virtual Congress –
SOUTH SAN FRANCISCO, CA, USA I June 13, 2020 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase III VIALE-A study, evaluating Venclexta® (venetoclax) in combination with azacitidine in people with previously untreated acute myeloid leukemia (AML) who were ineligible for intensive induction chemotherapy. VIALE-A results were featured in the 25th European Hematology Association Virtual Congress Press Briefing on Saturday, June 13, 2020 at 8:30 AM CEST and will be presented at the congress during the Late-breaking Oral Session (abstract #LB2601) on Sunday, June 14, 2020.
“We are very pleased to present these important results from people with acute myeloid leukemia, especially those who are unable to tolerate intensive chemotherapy and therefore have limited treatment options,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The significant survival benefits observed in the VIALE-A study reinforce the potential utility of this Venclexta-based combination for people with this aggressive disease.”
Results from the VIALE-A study showed that the Venclexta combination reduced the risk of death (overall survival [OS]) by 34% compared to azacitidine alone (median OS=14.7 months vs. 9.6 months; HR: 0.66, 95% CI: 0.52–0.85, p<0.001) in people with previously untreated AML. The Venclexta plus azacitidine combination also led to higher rates of composite complete remission (CR + CR with incomplete blood count recovery [CR + CRi]) at 66.4% compared to 28.3% with azacitidine alone (p<0.001).
Safety for Venclexta plus azacitidine appeared consistent with the known safety profile of these medicines and no unexpected safety signals were identified with the combination. Notable Grade 3 or higher adverse events in the Venclexta plus azacitidine and azacitidine alone arms included low platelet count (thrombocytopenia; 45% vs. 38%), low white blood cell count (neutropenia; 42% vs. 29%; leukopenia; 21% vs. 12%), low white blood cell count with fever (febrile neutropenia; 42% vs. 19%) and low red blood cell count (anemia; 26% vs. 20%).
The study also met its secondary endpoint of CR and CR with partial hematologic recovery (CR + CRh), with the combination showing a CR + CRh of 64.7% compared to 22.8% with azacitidine alone.
Data from the VIALE-A study has been shared with health authorities globally including the U.S. Food and Drug Administration (FDA). Venclexta has previously been granted accelerated approval by the FDA in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of people with newly diagnosed AML who are aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies. VIALE-A is part of Venclexta’s ongoing development program to convert the current accelerated approval of Venclexta, granted by the FDA in previously untreated AML, to a full approval. Venclexta has also been granted five Breakthrough Therapy Designations by the FDA, including two for previously untreated AML.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.
About the VIALE-A Study
VIALE-A (NCT02993523) is a Phase III, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of Venclexta® (venetoclax) plus azacitidine, a hypomethylating agent, compared to placebo plus azacitidine, in 433 people with previously untreated acute myeloid leukemia who are ineligible for intensive chemotherapy. Two-thirds of patients received 400 mg Venclexta daily, in combination with azacitidine, and the remaining patients received placebo tablets in combination with azacitidine. Patients enrolled in the study had a range of mutational subtypes, including IDH1/2 and FLT3. The primary endpoints of the study are overall survival (OS) and rate of complete remission (CR) and CR with incomplete blood count recovery (CRi). OS was the sole primary endpoint in the United States (U.S.) and U.S. reference countries, and OS and CR + CRi were co-primary endpoints in China, Japan, the European Union (EU) and EU reference countries. Secondary endpoints include CR and CR with partial hematologic recovery (CRh), event-free survival, transfusion independence and patient-reported outcomes.
| |
Venclexta plus azacitidine
(n=286) |
Azacitidine plus placebo
(n=145) |
| |
| Median OS |
14.7 months |
9.6 months |
| Hazard ratio: 0.66, 95% CI: 0.52–0.85, p<0.001 |
| CR + CRi |
66.4% |
28.3% |
| p<0.001 |
| |
| CR + CRh |
64.7% |
22.8% |
| p<0.001 |
| CR + CRi rates in molecular subgroups |
|
| IDH1/2 |
75% |
11% |
| p<0.001 |
| FLT3 |
72% |
36% |
| p=0.021 |
| NPM1 |
67% |
24% |
| p=0.012 |
| TP53 |
55% |
0% |
| p<0.001 |
About AML
Acute myeloid leukemia (AML) is the most common type of aggressive leukemia in adults, which has the lowest survival rate for all types of leukemia. In 2020, it is estimated there will be nearly 20,000 new cases of AML diagnosed in the United States. Many AML patients older than age 60 are unable to tolerate intensive induction chemotherapy treatment.
About Venclexta
Venclexta is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood and other cancers.
In the United States, Venclexta has been granted five Breakthrough Therapy Designations by the U.S. Food and Drug Administration: one for previously untreated chronic lymphocytic leukemia (CLL), two for relapsed or refractory CLL and two for previously untreated acute myeloid leukemia.
Venclexta Indications
Venclexta is a prescription medicine used:
- To treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- In combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
‒ Are 75 years of age or older, or
‒ Have other medical conditions that prevent the use of standard chemotherapy.
‒ Venclexta was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how Venclexta works over a longer period of time.
It is not known if Venclexta is safe and effective in children.
Please visit http://www.Venclexta.com for the Venclexta full Prescribing Information, including Patient Information, for additional Important Safety Information.
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: 23
