AbbVie Granted MHRA Approval for VENCLYXTO®▼ (venetoclax) as a Combination Treatment for Adults Newly Diagnosed with Acute Myeloid Leukaemia Who Are Ineligible for Intensive Chemotherapy

PRESS RELEASE

 

AbbVie Granted MHRA Approval for VENCLYXTO®▼ (venetoclax) as a Combination Treatment for Adults Newly Diagnosed with Acute Myeloid Leukaemia Who Are Ineligible for Intensive Chemotherapy

 

• VENCLYXTO® (venetoclax) in combination with a hypomethylating agent is approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy[1]
• Approval is based on data from AbbVie’s clinical trial programme for venetoclax, including the Phase 3 VIALE-A trial, which showed patients treated with venetoclax 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 venetoclax in combination with azacitidine or decitabine achieved high remission rates[3]

 

MAIDENHEAD, UK, June 7, 2021 – AbbVie today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved venetoclax in combination with a hypomethylating agent for the treatment of newly diagnosed adults with acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.¹ The approval applies to Great Britain [England, Scotland and Wales] and follows recent approval by the European Commission (EC) which applies to Northern Ireland in addition to all 27 EU states, Iceland, Liechtenstein and Norway.

 

“AML is an incredibly aggressive form of blood cancer, and patients who are diagnosed with this disease often cannot tolerate intensive chemotherapy due to advanced age and coexisting conditions” said Belinda Byrne, Medical Director, AbbVie UK. “Regulatory approval of venetoclax, is an important step forward in raising the standard of care for these patients, offering the potential to achieve remission with a manageable safety profile.”

 

This is the third extension of indications for venetoclax, 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 normally leads to natural cell death or the 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, non-randomised, multicentre M14-358 clinical trials. The VIALE-A trial demonstrated patients who received venetoclax in combination with azacitidine (n= 286) showed a statistically significantly greater median overall survival (OS) than patients receiving azacitidine alone (n=144) (14.7 vs. 9.6 months) (HR=0.66; 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 or the two medications alone.³

 

In the VIALE-A trial, the most frequently reported serious adverse events (AEs) (≥5%) in the venetoclax plus azacitidine arm, and placebo plus azacitidine arm, were febrile neutropenia, pneumonia, sepsis, and haemorrhage.¹ In the M14-358 trial, the most frequently reported serious AEs (≥5%) in patients receiving venetoclax in combination with decitabine were febrile neutropenia, pneumonia, bacteraemia and sepsis.¹

 

“The MHRA 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, Chief Executive of Leukaemia Care. “This approval represents an important advancement for the treatment of AML and offers an option for those who are ineligible for intensive chemotherapy.”

 

Venetoclax is being developed by AbbVie and Roche. It is commercialised by AbbVie outside of the U.S. and jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S.

-End-

 

For the venetoclax Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.

 

   Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact GBPV@abbvie.com.

AbbVie UK Media:

Natalie Bennett                                             Tabitha Grindrod

+44 (0)7818 428 074                                     +44 (0)7785 610696                                     

natalie.bennett@abbvie.com                     Tabitha.Grindrod@virgohealth.com

 

NOTES TO EDITORS:

 

About acute myeloid leukaemia

AML is an aggressive and difficult to treat blood cancer.[4] In the UK, an estimated 3,200 people are diagnosed with AML every year; this equates to more than 8 new cases every day.[5] Despite advances in available therapies and care, the five-year survival rate for patients diagnosed with AML remains approximately 20 percent.[6] AML typically worsens quickly, and due to age and comorbidities, not all patients can tolerate intensive induction chemotherapy.[7]

 

About the venetoclax AML clinical trial programme

AbbVie’s clinical trial programme to evaluate venetoclax combination therapy in patients with newly diagnosed AML who were ineligible for intensive chemotherapy included four 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 venetoclax 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 venetoclax plus azacitidine arm (n=286) versus 9.6 months in the placebo plus azacitidine arm (n=144), and the composite complete remission rate was 66.4 percent versus 28.3 percent, respectively (p<0.001). The study also met secondary endpoints, with the venetoclax plus azacitidine arm resulting in a CR rate of 36.7 percent vs. 17.9 percent in the placebo plus azacitidine arm (p<0.001). The safety profile of venetoclax 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 venetoclax plus azacitidine arm and placebo plus azacitidine arm were febrile neutropenia, pneumonia, sepsis, and haemorrhage.¹

 

M14-358 Phase 1b Trial

The non-randomized, open-label M14-358 trial evaluated venetoclax in combination with azacitidine or decitabine in patients with newly diagnosed AML who were ineligible for intensive chemotherapy. Patients treated with venetoclax in combination with decitabine (n=31) achieved a CR+CRi rate of 74 percent and a 30-day mortality rate of 6.5 percent.¹ The median follow-up was 40.4 months (range: 0.7 to 42.7 months) for venetoclax in combination with decitabine.¹ The most frequently reported serious AEs (≥5%) in patients receiving venetoclax in combination with decitabine were febrile neutropenia, pneumonia, bacteraemia and sepsis.¹ No events of laboratory or clinical TLS were reported with venetoclax in combination with decitabine.³

About venetoclax

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. Venetoclax targets the BCL-2 protein and works to help restore the process of apoptosis.

 

Venetoclax is being developed by AbbVie and Roche. It is jointly commercialised 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 and other cancers.

 

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.co.uk.

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.co.uk. Follow @abbvieuk on Twitter.

 

 

 

 

 

 

References

 

[1] Venetoclax Summary of Product Characteristics. Available at: https://mhraproducts4853.blob.core.windows.net/docs/692840bba2e3d9f62afc4e5265e1dd89677141e3

[Last Accessed June 2021]

[2] DiNardo CD, Jonas BA, 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.

[3] DiNardo CD, Pratz K, 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] American Cancer Society (2018). Typical Treatment of Most Types of Acute Myeloid Leukemia (Except Acute Promyelocytic M3). Available from: https://www.cancer.org/cancer/acute-myeloid-leukemia/treating/typical-treatment-of-aml.html. [Last accessed: May 2021]

[5] Cancer Research UK. Acute myeloid leukeamia (AML) statistics. Available from: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statisticsbycancer-type/leukaemia-aml#heading-Zero [Last Accessed: May 2021]

[6] Cancer Research UK. Survival. Available from: https://www.cancerresearchuk.org/about-cancer/acute-myeloidleukaemiaaml/survival [Last Accessed: May 2021]

[7] Pettit K, Odenike O. Defining and Treating Older Adults with Acute Myeloid Leukemia Who Are Ineligible for Intensive Therapies. Front Oncol. 2015; 5:250.