Dr Patrick Reville Covers Study Results on Venetoclax Combined With CLIA

Patrick Reville, MD, MPH, instructor, Department of Leukemia, MD Anderson Cancer Center, discusses the goals and findings of his study on venetoclax combined with cladribine, idarubicin, and cytarabine (CLIA) as an induction therapy for newly-diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

Transcript

What were the goals and main findings of your study?

The goal is really to try to improve upon the standard treatment that we give to patients with either newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Historically, we've separated the patients that are able to receive intensive chemotherapy or those that are not. For the patients that can receive intensive chemotherapy, the standard had been originally called “7+3,” which is 2 chemotherapy drugs given intensively over about a week and then followed by a consolidation, which for patients that are eligible would be allogeneic stem cell transplant.

What MD Anderson has done over the last 10 or 15 years has been work to improve upon the chemotherapy portion of that. That's kind of how the CLIA backbone was designed. It added a second purine analog—the cladribine—and increase the dose of the cytarabine to a higher dose cytarabine. That was the CLIA regimen. That work had been led by [Tapan M. Kadia, MD] within the group, and it showed nice outcomes.

Still, we weren't curing as many of these younger patients with AML as we had hoped. We hypothesized that we could add venetoclax to that combination. Venetoclax is a targeted drug targeting BCL-2. It’s been shown to be very active in AML, especially in patients that are ineligible for intensive chemotherapy. We added it to the intensive chemotherapy backbone and are showing good results.

I think that's similar to what we had expected based on our experience in the lower-intensity therapy. Venetoclax does seem to be improving the outcomes for these patients. We, again, show that it's very active. The response rate on this study was about 96%, which is higher than we would have expected with the CLIA alone or the standard “7+3” regiment alone. The longer-term outcomes seem to be showing encouraging efficacy. Patients are remaining in response longer, and their survival seems to be improved with the addition of this regimen.

Did treatment results vary between patient groups?

The results, I'd say, in general, are pretty comparable between those 3 groups. We've enrolled 67 patients to date, 60 of those 67 had AML, 4 patients had high-risk MDS, and 3 patients had a mixed phenotype acute leukemia. The response rate was 100% for the MDS and the mixed phenotype acute leukemia patients, but those numbers are relatively small overall. I'd say that our interpretation of that data is that this regimen is similarly active in each of those 3 categories.