CLARITY Trial Update of Ibrutinib Plus Venetoclax in Resistant CLL
Posted: Tuesday, November 5, 2019
Although ibrutinib and venetoclax have both significantly improved survival in patients with chronic lymphocytic leukemia (CLL), they are usually taken indefinitely or until disease progression, and rarely do they completely eradicate detectable disease. Peter Hillmen, MBChB, PhD, of the University of Leeds, United Kingdom, and colleagues found that, when taken together, ibrutinib and venetoclax appear to be safe, tolerable, and associated with increased rates of remission. The CLARITY study was a phase II trial published in the Journal of Clinical Oncology.
To determine the safety and efficacy of the combination therapy, the investigators administered ibrutinib plus venetoclax to 53 patients with relapsed or refractory CLL. After 12 months of treatment, 28 patients (53%) achieved a negative measurable residual disease level in the blood and 19 patients (36%) in the marrow. Overall, 47 patients (89%) responded, and over half of the patient population achieved complete remission (n = 27). At 14 months, two patients achieved confirmation that there was no detectable disease and completely stopped therapy. After a median follow-up of 21 months, all patients remained alive, and a single patient experienced disease progression.
Adverse events were consistent with existing safety profiles of ibrutinib and venetoclax. None of the observed adverse events were fatal, and a single case of biochemical tumor-lysis syndrome was reported. Common adverse events included neutropenia (n = 34) or gastrointestinal events (n = 9); however, they were generally mild and the therapy was well tolerated. All serious adverse events were resolved with appropriate management, and none of the patients discontinued participation in the study.
Disclosure: For full disclosures of study authors, visit ascopubs.org.