Four-year follow-up data from a phase II study evaluating obinutuzumab (Gazyva), ibrutinib (Imbruvica), and venetoclax (Venclexta) in patients with chronic lymphocytic leukemia (CLL) were presented at the American Society of Clinical Oncology annual meeting.
In this exclusive MedPage Today video, Kerry Rogers, MD, of the Ohio State University Comprehensive Cancer Center in Columbus, discusses the findings and next steps with the triplet regimen.
Following is a transcript of her remarks:
I was really excited to present a poster at this meeting that has continued follow-up on our phase II study of the combination of obinutuzumab, ibrutinib, and venetoclax in CLL. This has just been a really exciting study because it combined our kind of three most effective drugs from different classes in CLL for a 1-year treatment scheme.
And the really important thing is just after people complete this 1-year treatment, how long are they going to stay in remission, or how effective is this going to be after treatment has kind of finished? So, it’s really great to see that the first 50 people we treated in the phase II portion of the study are now out around 4 years from starting treatment, and to see that the majority have actually remained in remission is fantastic.
We also reported on 25 patients we’ve treated additionally in this study that were taking this as a first treatment and they’re only a little more than 2 years out from starting the treatment, but the response rates continue to look excellent, very similar to what we saw with the first 50 patients.
And there were no new safety signals or no new side effects of the treatment that were concerning. So, it’s just really exciting, I think, for both the investigators and hopefully the patients to see that people remain in remission off treatment.
This was a phase II study. We will continue to follow all of these patients in the study. Because I think with these fixed-duration regimens, how long people remain in remission is important.
But also, the comparison is kind of venetoclax and obinutuzumab fixed-duration treatment. So, we’d really like to know with these BTK [Bruton’s tyrosine kinase] inhibitor-venetoclax combinations, if there’s a subgroup of patients that benefits more from the fixed duration with the BTK inhibitor or not. And then of course it’s unanswered, compared to ibrutinib-venetoclax, do you need ibrutinib, venetoclax, obinutuzumab — do you need the antibody? And so those are questions that will be answered in follow-up and also phase III trials.
The three-drug regimen with obinutuzumab, ibrutinib, and venetoclax — that was kind of based on our phase II study that I’m reporting follow-up from — is now being studied in two ongoing U.S. oncology cooperative group trials, one through the Alliance and one through ECOG, and both with the comparator of ibrutinib and obinutuzumab, where the ibrutinib is given continuously and indefinitely. So, I think that’s really going to answer the question in the phase III trials. While we’re going to continue to follow our patients in this phase II, the phase III studies are really going to give us some extremely important answers.
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