期刊
CANCER DISCOVERY
卷 10, 期 3, 页码 394-405出版社
AMER ASSOC CANCER RESEARCH
DOI: 10.1158/2159-8290.CD-19-1130
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资金
- Acerta Pharma, a member of the AstraZeneca Group
- Ohio State University Leukemia Tissue Bank - NIH [P30 CA016058, R01 CA197870, R35 CA198183]
- Four Winds Foundation
- D. Warren Brown Foundation
Acalabrutinib is a selective irreversible Bruton tyrosine kinase (BTK) inhibitor that does not affect IL2-associated tyrosine kinase or antibody-dependent cellular cytotoxicity, making it an attractive candidate for combination therapy with anti-CD20 antibodies. We investigated acalabrutinib plus obinutuzumab in a phase Ib/II study (NCT02296918) of patients with treatment-naive or relapsed/refractory chronic lymphocytic leukemia (CLL). Nineteen treatment-naive and 26 relapsed/refractory patients were treated with acalabrutinib (100 mg twice daily) until progression and obinutuzumab (cycle 1: 100 mg day 1, 900 mg day 2, 1000 mg days 8 and 15; cycles 2-6: 1,000 mg day 1). Grade 3/4 adverse events occurred in 71% of patients. Overall response rates were 95% (treatment-naive) and 92% (relapsed/refractory). Thirty-two percent of treatment-naive and 8% of relapsed/refractory patients achieved complete remission. At 36 months, 94% (treatment-naive) and 88% (relapsed/refractory) were progression free. Acalabrutinib plus obinutuzumab was well tolerated, producing high and durable responses in treatment-naive and relapsed/refractory CLL. SIGNIFICANCE: Rituximab plus the less selective BTK inhibitor ibrutinib has not shown benefit in CLL; however, the selective BTK inhibitor acalabrutinib plus the antibody-dependent cellular cytotoxicity-enhanced antibody obinutuzumab yielded durable responses that deepened over time in treatment-naive and relapsed/refractory CLL, supporting the evaluation of this approach in larger, comparative studies in CLL.
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