High-Risk Subset of CLL Patients Shows Benefit in Phase II Trial
A statistically significant percentage of chronic lymphocytic leukemia patients in a phase II clinical trial responded to venetoclax therapy.
The open-label study, sponsored by AbbVie, met its primary endpoint, achieving overall response rates in patients with relapsed/refractory or previously untreated CLL with 17p deletion, according to an independent review analysis.
The study enrolled 157 patients, 107 in the main study cohort evaluating efficacy, and 50 patients in the safety expansion cohort.
The primary efficacy endpoint is overall response rate, and the primary safety endpoints are the number and percentage of patients who experienced treatment-related adverse events, changes in physical exam findings, including vital signs, changes in clinical laboratory test results and changes in cardiac assessment findings.