Fixed-duration therapy with pirtobrutinib (Jaypirca) plus venetoclax (Venclexta) and rituximab improved progression-free survival (PFS) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), according to interim data from the phase III BRUIN CLL-322 trial.
In the intent-to-treat population, median PFS was not estimable with the triplet therapy versus 39.7 months with venetoclax and rituximab, with independent review committee-assessed 24-month PFS rates of 86.9% and 71.8% (HR 0.547, 95% CI 0.400-0.748, P=0.0001), reported Matthew S. Davids, MD, of Dana-Farber Cancer Institute in Boston, at the European Hematology Association annual congress in Stockholm.
The investigator-assessed 24-month PFS rates were 88.2% versus 71.9%, respectively (HR 0.487, 95% CI 0.352-0.674, P<0.0001).
"These results establish PVR [pirtobrutinib plus venetoclax and rituximab] as a potential new standard-of-care option for patients with previously treated CLL," Davids said during a late-breaking abstract session.
Over the past 10 to 15 years, chemoimmunotherapy has been largely replaced by Bruton's tyrosine kinase (BTK) and BCL-2 inhibitors in the treatment of relapsed/refractory CLL, with a common treatment sequence that starts with a covalent BTK inhibitor until time of progression, followed by fixed-duration therapy with venetoclax and rituximab.
