At the recent 2019 American Society of Hematology annual meeting, researchers reported results of a comparison of venetoclax and placebo in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma.
In this exclusive 鶹ý video, , director of the Judy and Bernard Briskin Center for Multiple Myeloma Research at City of Hope in Duarte, California, discusses the results and the prior challenges.
Following is a transcript of her remarks:
There are a couple of exciting abstracts at this meeting -- actually several of them -- on a drug called venetoclax, which is being studied now in myeloma. It's already approved for other diseases, but we've taken that drug and want to study it in myeloma. There are two abstracts of particular interest looking at patients who have a specific translocation -- translocation 11;14. In those patients, one of the abstracts combined venetoclax with daratumumab, an anti-CD38 monoclonal antibody, plus venetoclax, plus dexamethasone and showed very high response rates, up to 90% of patients, with a very good safety profile.
Another abstract looked at venetoclax plus dexamethasone and also showed very good response rates -- specifically in patients with that 11;14 translocation. I think the myeloma world is feeling more and more strongly as this data continues to emerge, that certainly for patients with the 11;14 translocation, venetoclax is a very effective drug and we really are going to continue to use it and hopefully even maybe move it earlier in therapy and hopefully get it approved eventually for use in these patients.
There have been challenges with it. The BELLINI study, which was a large phase III study of venetoclax plus bortezomib and dexamethasone, while showing a progression-free survival advantage to that arm with venetoclax did not show an overall survival benefit because of a high death rate in the venetoclax arm, so that study was put on hold. That sort of put a lot of the brakes on it. I think the myeloma community, though, certainly does not want to give up on that drug at all, because we feel it's a very effective drug, and it may be just a better matter of understanding the dose of the drug and how to incorporate better supportive care for these patients and understanding the infection risks.
The toxicity in the BELLINI trial was the infection risk, and that is something we do remain very vigilant about and trying to understand how to best support patients to mitigate that risk. The other risks are pretty much what you see in advanced myeloma, some low blood counts. The GI toxicity was pretty manageable, so again, I think the toxicity profile, except for the infection part, has not been cause for concern.