• CANOVA study evaluated venetoclax plus dexamethasone in patients with t(11;14)-positive multiple myeloma compared to pomalidomide plus dexamethasone
  • Results are being presented at the International Myeloma Society Annual Meeting in Athens, Greece
  • AbbVie will discuss the data with health authorities in the near future to further understand the potential of venetoclax as a biomarker-driven therapy in multiple myeloma

NORTH CHICAGO, IL, USA I September 29, 2023 I AbbVie (NYSE: ABBV) today announced data from its Phase 3 CANOVA study evaluating the safety and efficacy of venetoclax (VENCLEXTA®/ VENCLYXTO®) plus dexamethasone (VenDex) for patients with t(11;14)-positive relapsed or refractory (R/R) multiple myeloma who have received two or more prior treatments. Data did not demonstrate that the treatment combination significantly improved progression-free survival (PFS), the primary endpoint of the trial. Patients receiving VenDex showed improvement in median PFS of 9.9 months compared to 5.8 months with the combination of study comparator pomalidomide and dexamethasone (PomDex); however, the results did not reach statistical significance [HR = 0.823, 95% CI: (0.596, 1.136); p-value of 0.237]. 

Select prespecified secondary endpoints from the CANOVA trial include the following:

  • Overall response rate (ORR): 62% in VenDex vs. 35% in PomDex (nominal p-value of <0.001)
  • Rate of very good partial response or better (VGPR) at 39% in VenDex vs. 14% in PomDex (nominal p-value of <0.001)
  • Median overall survival (OS) was 32.4 months in VenDex vs. 24.5 months in PomDex [HR of 0.697 (95% CI: 0.472, 1.029); nominal p-value of 0.067]

Additional prespecified analyses include:

  • PFS per investigator which resulted in a median PFS of 9.1 months with VenDex vs 4.9 months with PomDex [HR = 0.737, (95% CI: 0.543, 1.000); nominal p-value of 0.050]
  • Median time to next treatment (TTNT) which was longer in the VenDex arm 21.2 months vs. 8.3 months in the PomDex arm [HR of 0.546 (95% CI: 0.385, 0.776); nominal p-value of 0.001]

The safety profile of the combination of venetoclax and dexamethasone in the trial was generally consistent with the known safety profiles when used as single agents and no new safety signals have emerged. The most common adverse events (AEs) experienced by patients (>20%) treated with VenDex included any infection (61%), diarrhea (41%), lymphopenia (24%) and nausea (22%). The most common AEs experienced by subjects treated with PomDex included neutropenia (63%), any infection (57%), thrombocytopenia (39%) and anemia (35%). 

Multiple myeloma is the second most common blood cancer in the world.1 Many patients experience poor outcomes as most eventually relapse despite recent treatment advances. A subset of patients have the t(11;14) biomarker, the most common chromosomal translocation in multiple myeloma, that can signal an overexpression of the BCL-2 protein.2 

“While the CANOVA trial did not meet its primary endpoint, given the potential favorable trends seen in the study, we will discuss these data with health authorities in the near future,” said Mariana Cota Stirner, M.D., Ph.D., therapeutic area head oncology hematology, AbbVie. “We remain committed to elevating the standard of care for blood cancer patients around the world including patients with multiple myeloma.”

Venetoclax is currently approved for patients with previously untreated and treated chronic lymphocytic leukemia (CLL) and newly diagnosed acute myeloid leukemia (AML). Venetoclax is not approved by any regulatory authority in any country for the treatment of multiple myeloma. 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 the CANOVA Study3
CANOVA is a Phase 3, multicenter, randomized, open label study of either venetoclax or pomalidomide in combination with dexamethasone in patients with t(11;14)-positive R/R multiple myeloma. The study was initiated in 2018 and enrolled 263 patients 18 years and older with a documented diagnosis of multiple myeloma with t(11;14)-positive disease based on standard International Myeloma Working Group (IMWG) criteria, who had received at least two prior lines of therapy.

The primary endpoint of the trial was IRC-assessed PFS. Secondary endpoints include ORR, VGPR or better response rate, OS and MRD negativity rate defined at 10-5 threshold, as measured by centralized testing of bone marrow aspirate samples by next generation sequencing.

About Multiple Myeloma
Multiple myeloma is a type of blood cancer that affects plasma cells, which grow out of control and accumulate in the body’s bone marrow.1,4 Multiple myeloma is the second most common blood cancer in the world.1 An estimated 176,000 people globally were diagnosed with multiple myeloma in 2020, and 117,000 people died from the disease.5 In approximately 16% to 24% of people with multiple myeloma, t(11;14) is the most frequently seen chromosomal translocation.2

Nearly all multiple myeloma patients eventually relapse, which is associated with poor outcomes, and each remission is typically shorter than the previous one.6

About VENCLEXTA®/VENCLYXTO® (venetoclax) 
VENCLEXTA/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.

VENCLEXTA/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 and other cancers. Venetoclax is approved in more than 80 countries, including the U.S.

Indication and Important VENCLYXTO® ▼ (venetoclax) EU Safety Information7


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 www.abbvie.com/oncology and our Blood Cancer Press Kit page.

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook, Instagram, X (formerly Twitter), and YouTube.