— VENCLYXTO® (venetoclax) in combination with a hypomethylating agent is a new regimen approved by the European Commission (EC) for patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy [1]
— Approval is based on data from AbbVie’s clinical trial program for VENCLYXTO, including the Phase 3 VIALE-A trial, which showed patients treated with VENCLYXTO in combination with azacitidine demonstrated improvements in overall survival versus patients treated with placebo in combination with azacitidine [2]
— Approval is also based on results of the Phase 1b M14-358 trial which showed patients treated with VENCLYXTO in combination with azacitidine or decitabine achieved high remission rates [3]
NORTH CHICAGO, IL, USA I May 25, 2021 I AbbVie (NYSE: ABBV) announced today that the European Commission (EC) has approved VENCLYXTO® (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.1 The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway.
“VENCLYXTO has proven incremental overall survival in treating newly diagnosed AML in patients who are ineligible for intensive chemotherapy when treated with VENCLYXTO plus azacitidine compared to those treated with azacitidine alone,” said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. “We look forward to bringing VENCLYXTO to more AML patients who can potentially benefit from this important new treatment option in EU countries.”
This is the third extension of indications for VENCLYXTO, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells.1
This most recent approval is based on results from the Phase 3 double-blind, placebo-controlled VIALE-A (M15-656) and the Phase 1b open-label, nonrandomized, multicenter M14-358 clinical trials. The VIALE-A trial demonstrated patients who received VENCLYXTO in combination with azacitidine showed statistically significantly greater median overall survival (OS) than patients receiving azacitidine alone (p<0.001).2 The Phase 1b M14-358 trial evaluating venetoclax in combination with hypomethylating agents, azacitidine or decitabine, exhibited an overall safety profile that was generally consistent with the known safety profiles of venetoclax combined with azacitidine and the two medications alone.3
In the VIALE-A trial, the most frequently reported serious adverse events (AEs) in the VENCLYXTO plus azacitidine arm and placebo plus azacitidine arm were febrile neutropenia, pneumonia, sepsis, and haemorrhage.2 In the M14-358 trial, the most frequently reported serious AEs in patients receiving VENCLYXTO in combination with decitabine were febrile neutropenia, pneumonia, bacteraemia and sepsis.3
“The European Commission approval of venetoclax combination therapy offers a new option for people facing what is often a devastating acute myeloid leukemia diagnosis,” said Zack Pemberton-Whiteley, Chair of the Acute Leukemia Advocates Network. “This approval represents an important advancement for the treatment of AML and offers an option for those who are ineligible for intensive chemotherapy.”
In April 2021, AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for the Marketing Authorization Application for VENCLYXTO in combination with hypomethylating agents for the treatment of patients with newly diagnosed AML who are ineligible for intensive chemotherapy.
VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
About Acute Myeloid Leukemia
AML is the most common acute leukemia in the world.4 An estimated 160,000 people are currently living with the disease globally.4 The rate of new cases of acute myeloid leukemia is 4.3 per 100,000 men and women per year.5 It is also among the most difficult blood cancers to treat.6 Despite advances in available therapies and care, the five-year survival rate for patients diagnosed with AML remains approximately 29 percent.5 AML typically worsens quickly, and due to age and comorbidities, not all patients can tolerate intensive chemotherapy.7
About the VENCLYXTO AML Clinical Trial Program
AbbVie’s clinical trial program to evaluate VENCLYXTO combination with a hypomethylating agent in patients with newly diagnosed acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy included two studies conducted around the world.
VIALE-A (M15-656) Phase 3 Trial2
The randomized, double-blind, placebo-controlled VIALE-A (M15-656) trial evaluated the efficacy and safety of VENCLYXTO in combination with azacitidine in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The study met its primary endpoints of statistically significant improvement of overall survival (OS) and composite complete remission (complete remission [CR]+complete remission with incomplete hematologic recovery [CRi]) (CR + CRi). Overall survival was 14.7 months for the VENCLYXTO plus azacitidine arm versus 9.6 months in the placebo plus azacitidine arm, and the composite complete remission rate was 66.4 percent versus 28.3 percent, respectively. The study also met secondary endpoints, with the VENCLYXTO plus azacitidine arm resulting in a CR rate of 36.7 percent vs. 17.9 percent in the placebo plus azacitidine arm. The safety profile of VENCLYXTO plus azacitidine was consistent with the known side-effect profiles of both agents, and adverse events (AEs) were consistent with expectations for an older AML population. The most frequently reported serious AEs in the VENCLYXTO plus azacitidine arm and placebo plus azacitidine arm were febrile neutropenia (in 30 percent and 10 percent), pneumonia (in 17 percent and 22 percent), sepsis (in 6 percent and 8 percent), and haemorrhage (in 9 percent and 6 percent), respectively.2
M14-358 Phase 1b Trial3
The non-randomized, open-label M14-358 trial evaluated VENCLYXTO in combination with azacitidine or decitabine in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. Patients treated with VENCLYXTO in combination with decitabine achieved a CR+CRi rate of 74 percent and a 30-day mortality rate of 6.5 percent. The median follow-up was 40.4 months (range: 0.7 to 42.7 months) for venetoclax in combination with decitabine. The most frequently reported serious AEs (≥5%) in patients receiving VENCLYXTO in combination with decitabine were febrile neutropenia, pneumonia, bacteraemia and sepsis, with neutropenia reported in 35 percent (all grades) and 35 percent (grade 3 or 4) of patients in the venetoclax + decitabine arm. No events of laboratory or clinical TLS were reported with venetoclax in combination with decitabine.
About VENCLYXTO® (venetoclax)
VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.
VENCLYXTO is also approved in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL), in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of CLL in the presence or absence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.1
VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood. Venetoclax is approved in more than 80 countries, including the U.S.
Indications and Important Venclyxto (venetoclax) EU Safety Information1
Indications
Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
Venclyxto monotherapy is indicated for the treatment of CLL:
- In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
- In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
| 1 |
Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. |
| 2 |
DiNardo, C.D., Jonas, B.A., et al. A Randomized, Double-Blind, Placebo-Controlled Study of Venetoclax With Azacitidine Vs. Azacitidine In Treatment-Naïve Patients with Acute Myeloid Leukemia Ineligible For Intensive Therapy: The Phase 3 VIALE-A Trial. (2020). |
| 3 |
DiNardo CD, et al. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019 Jan 3;133(1):7-17. doi: 10.1182/blood-2018-08-868752. Epub 2018 Oct 25. |
| 4 |
Puty, T.C., Sarraf, J.S., Do Carmo Almeida, T.C. et al. Evaluation of the impact of single-nucleotide polymorphisms on treatment response, survival and toxicity with cytarabine and anthracyclines in patients with acute myeloid leukaemia: a systematic review protocol. Syst Rev 8, 109 (2019). |
| 5 |
National Cancer Institute (2018). Acute Myeloid Leukemia – SEER Stat Fact Sheets. https://seer.cancer.gov/statfacts/html/amyl.html. Accessed May 20, 2021 |
| 6 |
American Cancer Society (2018). Typical Treatment of Most Types of Acute Myeloid Leukemia (Except Acute Promyelocytic M3). https://www.cancer.org/cancer/acute-myeloid-leukemia/treating/typical-treatment-of-aml.html. Accessed May 20, 2021 |
| 7 |
Pettit, K and Odenike, O. Defining and Treating Older Adults with Acute Myeloid Leukemia Who Are Ineligible for Intensive Therapies. Front Oncol. 2015; 5:250. |
SOURCE: AbbVie
Post Views: 23
— VENCLYXTO® (venetoclax) in combination with a hypomethylating agent is a new regimen approved by the European Commission (EC) for patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy [1]
— Approval is based on data from AbbVie’s clinical trial program for VENCLYXTO, including the Phase 3 VIALE-A trial, which showed patients treated with VENCLYXTO in combination with azacitidine demonstrated improvements in overall survival versus patients treated with placebo in combination with azacitidine [2]
— Approval is also based on results of the Phase 1b M14-358 trial which showed patients treated with VENCLYXTO in combination with azacitidine or decitabine achieved high remission rates [3]
NORTH CHICAGO, IL, USA I May 25, 2021 I AbbVie (NYSE: ABBV) announced today that the European Commission (EC) has approved VENCLYXTO® (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.1 The approval is valid in all 27 member states of the EU, as well as Iceland, Liechtenstein, and Norway.
“VENCLYXTO has proven incremental overall survival in treating newly diagnosed AML in patients who are ineligible for intensive chemotherapy when treated with VENCLYXTO plus azacitidine compared to those treated with azacitidine alone,” said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. “We look forward to bringing VENCLYXTO to more AML patients who can potentially benefit from this important new treatment option in EU countries.”
This is the third extension of indications for VENCLYXTO, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells.1
This most recent approval is based on results from the Phase 3 double-blind, placebo-controlled VIALE-A (M15-656) and the Phase 1b open-label, nonrandomized, multicenter M14-358 clinical trials. The VIALE-A trial demonstrated patients who received VENCLYXTO in combination with azacitidine showed statistically significantly greater median overall survival (OS) than patients receiving azacitidine alone (p<0.001).2 The Phase 1b M14-358 trial evaluating venetoclax in combination with hypomethylating agents, azacitidine or decitabine, exhibited an overall safety profile that was generally consistent with the known safety profiles of venetoclax combined with azacitidine and the two medications alone.3
In the VIALE-A trial, the most frequently reported serious adverse events (AEs) in the VENCLYXTO plus azacitidine arm and placebo plus azacitidine arm were febrile neutropenia, pneumonia, sepsis, and haemorrhage.2 In the M14-358 trial, the most frequently reported serious AEs in patients receiving VENCLYXTO in combination with decitabine were febrile neutropenia, pneumonia, bacteraemia and sepsis.3
“The European Commission approval of venetoclax combination therapy offers a new option for people facing what is often a devastating acute myeloid leukemia diagnosis,” said Zack Pemberton-Whiteley, Chair of the Acute Leukemia Advocates Network. “This approval represents an important advancement for the treatment of AML and offers an option for those who are ineligible for intensive chemotherapy.”
In April 2021, AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion for the Marketing Authorization Application for VENCLYXTO in combination with hypomethylating agents for the treatment of patients with newly diagnosed AML who are ineligible for intensive chemotherapy.
VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
About Acute Myeloid Leukemia
AML is the most common acute leukemia in the world.4 An estimated 160,000 people are currently living with the disease globally.4 The rate of new cases of acute myeloid leukemia is 4.3 per 100,000 men and women per year.5 It is also among the most difficult blood cancers to treat.6 Despite advances in available therapies and care, the five-year survival rate for patients diagnosed with AML remains approximately 29 percent.5 AML typically worsens quickly, and due to age and comorbidities, not all patients can tolerate intensive chemotherapy.7
About the VENCLYXTO AML Clinical Trial Program
AbbVie’s clinical trial program to evaluate VENCLYXTO combination with a hypomethylating agent in patients with newly diagnosed acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy included two studies conducted around the world.
VIALE-A (M15-656) Phase 3 Trial2
The randomized, double-blind, placebo-controlled VIALE-A (M15-656) trial evaluated the efficacy and safety of VENCLYXTO in combination with azacitidine in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. The study met its primary endpoints of statistically significant improvement of overall survival (OS) and composite complete remission (complete remission [CR]+complete remission with incomplete hematologic recovery [CRi]) (CR + CRi). Overall survival was 14.7 months for the VENCLYXTO plus azacitidine arm versus 9.6 months in the placebo plus azacitidine arm, and the composite complete remission rate was 66.4 percent versus 28.3 percent, respectively. The study also met secondary endpoints, with the VENCLYXTO plus azacitidine arm resulting in a CR rate of 36.7 percent vs. 17.9 percent in the placebo plus azacitidine arm. The safety profile of VENCLYXTO plus azacitidine was consistent with the known side-effect profiles of both agents, and adverse events (AEs) were consistent with expectations for an older AML population. The most frequently reported serious AEs in the VENCLYXTO plus azacitidine arm and placebo plus azacitidine arm were febrile neutropenia (in 30 percent and 10 percent), pneumonia (in 17 percent and 22 percent), sepsis (in 6 percent and 8 percent), and haemorrhage (in 9 percent and 6 percent), respectively.2
M14-358 Phase 1b Trial3
The non-randomized, open-label M14-358 trial evaluated VENCLYXTO in combination with azacitidine or decitabine in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. Patients treated with VENCLYXTO in combination with decitabine achieved a CR+CRi rate of 74 percent and a 30-day mortality rate of 6.5 percent. The median follow-up was 40.4 months (range: 0.7 to 42.7 months) for venetoclax in combination with decitabine. The most frequently reported serious AEs (≥5%) in patients receiving VENCLYXTO in combination with decitabine were febrile neutropenia, pneumonia, bacteraemia and sepsis, with neutropenia reported in 35 percent (all grades) and 35 percent (grade 3 or 4) of patients in the venetoclax + decitabine arm. No events of laboratory or clinical TLS were reported with venetoclax in combination with decitabine.
About VENCLYXTO® (venetoclax)
VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.
VENCLYXTO is also approved in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL), in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of CLL in the presence or absence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.1
VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood. Venetoclax is approved in more than 80 countries, including the U.S.
Indications and Important Venclyxto (venetoclax) EU Safety Information1
Indications
Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
Venclyxto monotherapy is indicated for the treatment of CLL:
- In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
- In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
| 1 |
Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG. |
| 2 |
DiNardo, C.D., Jonas, B.A., et al. A Randomized, Double-Blind, Placebo-Controlled Study of Venetoclax With Azacitidine Vs. Azacitidine In Treatment-Naïve Patients with Acute Myeloid Leukemia Ineligible For Intensive Therapy: The Phase 3 VIALE-A Trial. (2020). |
| 3 |
DiNardo CD, et al. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Blood. 2019 Jan 3;133(1):7-17. doi: 10.1182/blood-2018-08-868752. Epub 2018 Oct 25. |
| 4 |
Puty, T.C., Sarraf, J.S., Do Carmo Almeida, T.C. et al. Evaluation of the impact of single-nucleotide polymorphisms on treatment response, survival and toxicity with cytarabine and anthracyclines in patients with acute myeloid leukaemia: a systematic review protocol. Syst Rev 8, 109 (2019). |
| 5 |
National Cancer Institute (2018). Acute Myeloid Leukemia – SEER Stat Fact Sheets. https://seer.cancer.gov/statfacts/html/amyl.html. Accessed May 20, 2021 |
| 6 |
American Cancer Society (2018). Typical Treatment of Most Types of Acute Myeloid Leukemia (Except Acute Promyelocytic M3). https://www.cancer.org/cancer/acute-myeloid-leukemia/treating/typical-treatment-of-aml.html. Accessed May 20, 2021 |
| 7 |
Pettit, K and Odenike, O. Defining and Treating Older Adults with Acute Myeloid Leukemia Who Are Ineligible for Intensive Therapies. Front Oncol. 2015; 5:250. |
SOURCE: AbbVie
Post Views: 23
