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News
A first-line triplet regimen of pirtobrutinib, venetoclax, and obinutuzumab is showing impressive results in treatment-naïve chronic lymphocytic leukemia (CLL). In the phase 2 PIVOT-CLL trial, 2-year progression-free and overall survival rates both hit 99%, with deep remissions seen in the majority of patients. The catch? High rates of neutropenia raise real-world safety questions, especially for older or less fit patients.
A first-line triplet of pirtobrutinib (a non-covalent BTK inhibitor), venetoclax, and obinutuzumab is turning heads in CLL treatment. Results from the phase 2 PIVOT-CLL trial, presented at the SOHO 2026 Annual Meeting, showed that among 80 treatment-naïve patients followed for nearly 31 months, both 2-year progression-free survival (PFS) and overall survival (OS) hit 99% — remarkable figures for a disease that has historically been difficult to manage long-term.
Deep remission was also a standout: by the end of 13 treatment cycles, 96% of patients had undetectable minimal residual disease (MRD) in bone marrow at the standard 10⁻⁴ threshold. These results build on earlier phase 3 data (BRUIN CLL-322) showing pirtobrutinib-based triplets also outperform doublets in relapsed/refractory CLL, suggesting the drug may be reshaping treatment across disease stages.
By the Numbers:
Why it matters: This is the first trial to test a non-covalent BTK inhibitor in a frontline CLL triplet regimen, and the efficacy data are hard to ignore. However, the high neutropenia rates — and one infection-related death — raise concerns about whether this regimen is safe and practical for the broader, often older CLL population seen in community settings. Expansion to 160 patients is underway.
