Venclexta fails to meet primary endpoint in multiple myeloma trial

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AbbVie and Roche, pioneers in the field of leukemia treatments with Venclexta, faced a setback as their hopes to expand the drug’s utility to a subset of multiple myeloma patients did not yield the desired results.

In a clinical study, the combination of Venclexta and dexamethasone, aptly named VenDex, did not demonstrate a statistically significant ability to halt disease progression in patients with t(11;14)-positive relapsed or refractory multiple myeloma, individuals who had previously undergone at least two treatment regimens.

The patients treated with VenDex experienced a median progression-free survival of 9.9 months, surpassing the 5.8 months seen in those receiving Bristol Myers Squibb’s Pomalyst and dexamethasone (PomDex). However, this outcome did not reach the threshold for statistical significance, as reported by AbbVie.

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Despite missing the primary study endpoint, VenDex showcased an impressive overall response rate of 62%, notably higher than PomDex’s 35%, demonstrating its potential efficacy.

In terms of median overall survival, the VenDex group exhibited a noteworthy 32.4 months compared to PomDex’s 24.5 months, suggesting a potential advantage in extending patients’ lives.

Venclexta, a groundbreaking medication, operates by selectively binding and inhibiting the B-cell lymphoma-2 protein, which helps restore the process of apoptosis impaired in certain blood cancers.

Initially approved in 2016 for treating chronic lymphocytic leukemia (CLL) in patients with a specific chromosomal abnormality known as 17p deletion, Venclexta was the pioneering drug designed to target the B-cell lymphoma 2 protein.

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“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. We remain committed to elevating the standard of care for blood cancer patients around the world including patients with multiple myeloma.”

– Mariana Cota Stirner, M.D., Ph.D., therapeutic area head oncology hematology, AbbVie

More recently, Venclexta, in combination with AbbVie and Johnson & Johnson’s Imbruvica, received a recommendation from England’s National Institute for Health and Care Excellence (NICE) for treating previously untreated CLL.

In the United States, it is also indicated for CLL treatment in patients with or without 17p deletion who have already undergone one prior therapy, particularly when combined with Roche’s Rituxan.

While the VenDex study did not meet its primary endpoint, the drug’s remarkable overall response rate and extended median overall survival suggest there may still be promise for Venclexta in certain multiple myeloma patient subsets, warranting further investigation and potential refinements in treatment approaches.

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