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Long-Term Follow-up on Use of Venetoclax in Patients With CLL and 17P Deletion

By: Sarah Lynch
Posted: Thursday, August 11, 2022

Based on the final analyses of a phase II trial, with 6-year follow-up data, the BCL2 inhibitor venetoclax demonstrated long-term activity in patients with relapsed or untreated chronic lymphocytic leukemia (CLL) with 17p deletion or a mutated TP53 gene. Stephan Stilgenbauer, MD, of the Comprehensive Cancer Center Ulm, Germany, and colleagues reported that with a median follow-up of 70 months, 48% of patients were alive, and 24% were free of disease progression. These findings were presented at the European Hematology Association (EHA) 2022 Congress (Abstract S146).

“Except SF3B1 mutation, other adverse features (eg, more than one TP53 mutation, NOTCH1 mutations, unmatched IGHV) did not influence outcomes with venetoclax treatment in this cohort,” the investigators commented.

A total of 158 patients with relapsed or untreated del(17p) CLL were treated daily with 400 mg of oral venetoclax. Treatment continued until disease progression or patient intolerance of treatment. Peripheral blood and bone marrow were tested for somatic mutations before treatment, and measurable residual (MRD) was analyzed and assigned an allowed maximum of 10-4.

As mentioned, at a median follow-up of 70 months, 48% of patients were still alive and 24% were free of disease progression. The median duration of response was 39.3 months, and nearly one-third of patients (28%) had an ongoing response at 60 months. The investigator-reported overall response rate was 77%, and 21% of the patients achieved complete remission with incomplete blood cell count recovery. Of 61 evaluable patients who had undergone peripheral blood MRD assessment, 25% had undetectable MRD at approximately 2 years. In addition, the median overall survival was 62.5 months. A total of 16% of patients remained on venetoclax.

Disclosure: For full disclosures of the study authors, visit library.ehaweb.org.


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