BELLINI: Venetoclax or placebo with bortezomib and dexamethasone for relapsed/refractory multiple myeloma

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Published: 25 Sep 2019
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Prof Simon Harrison - Peter MacCallum Cancer Centre, Melbourne, Australia

Prof Simon Harrison talks to ecancer at the International Myeloma Workshop 2019 about the BELLINI study.

Prof Harrison begins by outlining the study design and results of the BELLINI study. 

He explains how toxicities were an issue with respect to the overall survival, and suggests why these toxicities might be occurring.

Prof Harrison explores the idea of other possibilities, but reminds us that we should not ignore venetoclax altogether.

ecancer's filming has been kindly supported by Amgen through the ecancer Global Foundation. ecancer is editorially independent and there is no influence over content. 

The BELLINI study is a phase III randomised study of Velcade dexamethasone randomised to venetoclax as a combination. The overall results of that study show that there’s a significant improvement in the response rate associated with that study but also in terms of progression free survival. The negative result reported in that study was that there seems to be an increase in toxicity associated with the combination producing some increased rates of infection in patients with multiple myeloma. That has translated into a negative result in terms of the overall survival.

The reasons why patients are having increased rates of infection is still not clear and it may be that there’s some degree of interaction and an immune suppressive effect of the combination versus the Velcade dexamethasone. However, in the (4,14) population and also in the patients with high expression of BCL2 there seems to be a significant advantage in terms of response rate with no significant increase in toxicity in that population.

Could a biomarker-driven approach be more suitable?

It’s an interesting question. In terms of when you look at the results of the study then clearly there’s a rationale to look at narrowing down the population in terms of the overall benefit. My personal take on the study is that improvements in terms of the deliverability and the tolerability of the regimen should be able to be achieved to reduce the toxicity and therefore expand the patient population who will benefit from the addition of venetoclax to Velcade and dexamethasone. One of the ways in which you might be able to achieve that is by reducing the frequency of administration of the dexamethasone and the Velcade to once a week rather than twice a week which was used in this study.

Is there anything you would like to add?

It’s important not to forget about venetoclax in non-t(11,14) patients because there’s a significant number of those patients who can still benefit if we can get the combination right and reduce the toxicity.