AbbVie reported negative results from a Phase III CANOVA trial investigating venetoclax in patients with relapsed or refractory multiple myeloma.

The trial evaluated the safety and efficacy of venetoclax in combination with dexamethasone (VenDex) compared with pomalidomide plus dexamethasone (PomDex). According to the announcement, the VenDex combo treatment did not significantly improve progression-free survival (PFS), which was the primary endpoint.

While participants treated with VenDex showed improvement in median PFS of 9.9 months versus 5.8 months in the comparator arm, the results did not reach statistical significance [HR = 0.823, 95% CI: (0.596, 1.136); p-value of 0.237].

As for the prespecified secondary endpoints, VenDex achieved an overall response rate (ORR) of 62% and a rate of very good partial response or better (VGPR) of 39%. The PomDex cohort achieved an ORR of 35% and VGPR of 14%. Median overall survival (OS) was 32.4 months in the VenDex cohort compared with 24.5 months in the comparator arm.

The safety profile of venetoclax in combination with dexamethasone, an anti-inflammatory agent, was generally consistent with known safety profiles when administered as single agents. No new safety signals have emerged in the trial. The study enrolled 263 patients who had received at least two prior lines of therapy.

AbbVie’s head of oncology and haematology Dr Mariana Cota Stirner said: “While the CANOVA trial did not meet its primary endpoint, given the potential favourable trends seen in the study, we will discuss these data with health authorities in the near future.”

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Bumpy ride for venetoclax

This is not the first blow for venetoclax in multiple myeloma. In March 2019, the US Food and Drug Administration (FDA) put a partial hold on all trials evaluating venetoclax.

The trial was put on hold following a data review from another Phase III combo therapy trial where a higher proportion of deaths were observed in the venetoclax arm compared with the control arm.

In June 2019, the FDA lifted the partial clinical hold after revising the CANOVA trial protocol to include new risk mitigation measures, protocol-specified guidelines and updated futility criteria.

Venetoclax in other indications

Venetoclax, marketed as Venclyxto and Venclexta, is currently approved for patients with previously untreated and treated chronic lymphocytic leukaemia (CLL) and newly diagnosed acute myeloid leukaemia (AML). The drug is jointly commercialised by Genentech in the US and AbbVie outside of the US.

In June 2023, AbbVie released six-year follow-up data from a Phase III trial in CLL and co-existing conditions. Patients treated with venetoclax in combination with obinutuzumab showed sustained PFS and higher undetectable minimal residual disease (uMRD) rates.

However, in 2020, venetoclax in combination with low-dose cytarabine, failed to meet the primary endpoint of OS in a Phase III VIALE-C trial in treatment-naïve AML patients.