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CANOVA

Venetoclax-Dexamethasone Versus Pomalidomide-Dexamethasone in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma: Primary Results of the Randomized, Phase III CANOVA Study

Phase 3N = 263NCT03539744

Population
Adults with t(11;14)-positive relapsed or refractory myeloma after at least two previous lines of therapy.
Design
Randomized, open-label phase III study of venetoclax-dexamethasone versus pomalidomide-dexamethasone until progression or intolerable toxicity. The primary end point was independent review committee-assessed progression-free survival in the intention-to-treat population (two-sided alpha 0.05, stratified log-rank test). Secondary end points included response rates, overall survival, MRD negativity and safety.
Primary endpoint
PFS
Arms
  • Venetoclax + dexamethasone (experimental, n = 133): Venetoclax with dexamethasone
  • Pomalidomide + dexamethasone (control, n = 130): Pomalidomide with dexamethasone
People
Popat R
PFSHR 0.823 (95% CI 0.596–1.136)Δ median PFS+4.1 monthsΔ ORR+27 pointsΔ MRD+8 pointsOSHR 0.856 (95% CI 0.612–1.197)Δ median OS+5.5 months
Show the numbers
Results reported for CANOVA
EndpointAnalysisVenetoclax + dexamethasonePomalidomide + dexamethasoneEffect
PFSITT population (263)primaryPopat 2026median 9.9 months (6.9–12.6)median 5.8 months (3.8–9.2)HR 0.823 (95% CI 0.596–1.136)P=0.24The primary end point was not met (the abstract's conclusion). Treatment-emergent deaths: 16 (12%) with venetoclax-dexamethasone and 8 (6%) with pomalidomide-dexamethasone. Grade 3 or higher treatment-emergent adverse events 67% versus 83%.
ORRITT population (263)primaryPopat 202662%35%Very good partial response or better 39% versus 14%.
MRDITT population (263)primaryPopat 20268%0%MRD negativity at a threshold of less than 10^-5.
OSITT population (263)primaryPopat 2026median 32.4 months (26.4–40.7)median 26.9 months (20.4–38.9)HR 0.856 (95% CI 0.612–1.197)
Results reported for CANOVA
EndpointAnalysisVenetoclax + dexamethasonePomalidomide + dexamethasoneEffect
PFSITT population (263)primaryPopat 2026median 9.9 months (6.9–12.6)median 5.8 months (3.8–9.2)HR 0.823 (95% CI 0.596–1.136)P=0.24The primary end point was not met (the abstract's conclusion). Treatment-emergent deaths: 16 (12%) with venetoclax-dexamethasone and 8 (6%) with pomalidomide-dexamethasone. Grade 3 or higher treatment-emergent adverse events 67% versus 83%.
ORRITT population (263)primaryPopat 202662%35%Very good partial response or better 39% versus 14%.
MRDITT population (263)primaryPopat 20268%0%MRD negativity at a threshold of less than 10^-5.
OSITT population (263)primaryPopat 2026median 32.4 months (26.4–40.7)median 26.9 months (20.4–38.9)HR 0.856 (95% CI 0.612–1.197)
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.8230.596–1.136
OS0.8560.612–1.197
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Venetoclax + dexamethasone (experimental)
  • Pomalidomide + dexamethasone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsVenetoclax + dexamethasonePomalidomide + dexamethasone
0100.0%100.0%
665.7%48.8%
1243.2%23.8%
1926.4%10.3%
2517.4%5.0%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080Months (modelled)
  • Venetoclax + dexamethasone (experimental)
  • Pomalidomide + dexamethasone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsVenetoclax + dexamethasonePomalidomide + dexamethasone
0100.0%100.0%
2065.2%59.7%
4141.6%34.8%
6127.1%20.8%
8117.7%12.4%
Primary publication: Popat R, Beksac M, Dimopoulos MA, Gatt ME, Gay F, Jo JC, et al. Venetoclax-Dexamethasone Versus Pomalidomide-Dexamethasone in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma: Primary Results of the Randomized, Phase III CANOVA Study. J Clin Oncol. 2026;44(3):164-175. PubMedDOI

Appears in

Sources

  1. Popat R, Beksac M, Dimopoulos MA, Gatt ME, Gay F, Jo JC, et al. Venetoclax-Dexamethasone Versus Pomalidomide-Dexamethasone in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma: Primary Results of the Randomized, Phase III CANOVA Study. J Clin Oncol. 2026;44(3):164-175.

    PubMedDOI