Zanubrutinib extends PFS in treatment-naive CLL
Zanubrutinib prolonged PFS compared with bendamustine plus rituximab among patients with treatment-naive chronic lymphocytic leukemia or small lymphocytic lymphoma who did not harbor deletion 17p.
The regimen also appeared well-tolerated, topline data released by the agent’s manufacturer showed.
Zanubrutinib (Brukinsa, BeiGene) is a Bruton tyrosine kinase inhibitor approved in the United States for treatment of adults with mantle cell lymphoma who received at least one prior therapy.
The randomized phase 3 SEQUOIA trial evaluated zanubrutinib vs. bendamustine plus rituximab (Rituxan; Genentech, Biogen) for patients with treatment-naive CLL or small lymphocytic lymphoma.
Cohort 1 of the trial included 479 patients who did not harbor deletion 17p.
Researchers randomly assigned these patients to zanubrutinib (n = 241) or bendamustine-rituximab (n = 238). Treatment continued until disease progression or unacceptable toxicity.
PFS assessed by independent review committee served as the primary endpoint. Secondary endpoints included investigator-assessed PFS; independent review committee- and investigator-assessed overall response rate; and other efficacy and safety outcomes.
After median follow-up of 25.8 months, results of an interim analysis showed zanubrutinib-treated patients achieved significantly longer PFS than those who received the chemoimmunotherapy regimen by both independent central review and investigator assessment.
Zanubrutinib also appeared well-tolerated, exhibiting a safety profile consistent with its known profile.
As Healio previously reported, results of the randomized phase 3 ALPINE trial showed zanubrutinib induced a higher overall response rate than ibrutinib (Imbruvica; Janssen, Pharmacyclics) among patients with relapsed or refractory CLL. Zanubrutinib also appeared associated with higher rates of 12-month PFS and OS.
“The combined clinical evidence from SEQUOIA, ALPINE [and other trials] validates our confidence in Brukinsa as a regimen [that] can offer improvements in treatment outcomes for hundreds of thousands of patients living with CLL,” Jane Huang, MD, chief medical officer for hematology with BeiGene, said in a company-issued press release. “We are pleased to see that at the interim analysis of the SEQUOIA trial, Brukinsa significantly prolonged progression-free survival for treatment-naive [patients with CLL], and that the demonstrated safety profile was consistent with what we have observed in its global development program with more than 2,300 patients treated with Brukinsa to date.”