Dr. Brander on the Safety and Efficacy of Ibrutinib/Venetoclax in CLL

Danielle M. Brander, MD
Published: Monday, May 06, 2019



Danielle M. Brander, MD, assistant professor of medicine, Duke Cancer Institute, discusses the safety and efficacy of the combination of venetoclax (Venclexta) and ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL).

In the phase II CLARITY (NCT02267590) trial, investigators are examining the combination of ibrutinib and venetoclax in patients with relapsed/refractory CLL. Preliminary results from the trial showed that the combination was both safe and effective, says Brander. No unanticipated toxicities were observed when the agents were combined. What sets this study apart from prior studies is that patients were treated with 3 months of ibrutinib before they were given the combination. As a result, patients experienced a reduction in tumor lysis risk and disease bulk, subsequently enhancing the safety profile of the regimen, says Brander.

In terms of efficacy, the results from the first preplanned analysis showed that approximately 76% of patients achieved undetectable levels of minimal residual disease negativity, she adds. Furthermore, almost all patients achieved an objective response with the combination. Although longer follow-up will be necessary, these results suggest that patients who are eligible to receive the combination may have lower toxicity and time on treatment in the face of MRD negativity.
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Danielle M. Brander, MD, assistant professor of medicine, Duke Cancer Institute, discusses the safety and efficacy of the combination of venetoclax (Venclexta) and ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL).

In the phase II CLARITY (NCT02267590) trial, investigators are examining the combination of ibrutinib and venetoclax in patients with relapsed/refractory CLL. Preliminary results from the trial showed that the combination was both safe and effective, says Brander. No unanticipated toxicities were observed when the agents were combined. What sets this study apart from prior studies is that patients were treated with 3 months of ibrutinib before they were given the combination. As a result, patients experienced a reduction in tumor lysis risk and disease bulk, subsequently enhancing the safety profile of the regimen, says Brander.

In terms of efficacy, the results from the first preplanned analysis showed that approximately 76% of patients achieved undetectable levels of minimal residual disease negativity, she adds. Furthermore, almost all patients achieved an objective response with the combination. Although longer follow-up will be necessary, these results suggest that patients who are eligible to receive the combination may have lower toxicity and time on treatment in the face of MRD negativity.

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