FDA approves Brukinsa for chronic lymphocytic leukemia, small lymphocytic lymphoma
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The FDA approved zanubrutinib for treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma.
Zanubrutinib (Brukinsa, BeiGene) is a selective next-generation Bruton tyrosine kinase inhibitor.
The FDA based approval on efficacy results of two studies.
The randomized SEQUOIA study evaluated the agent for patients with treatment-naive CLL or small lymphocytic lymphoma (SLL)
One cohort included 479 patients without 17p deletion. Researchers randomly assigned participants to zanubrutinib — administered until disease progression or unacceptable toxicity — or bendamustine plus rituximab (Rituxan; Genentech, Biogen) for six cycles.
PFS assessed by independent review committee served as the main efficacy outcome.
After estimated median follow-up of 25 months, results showed longer median PFS in the zanubrutinib group (not reached vs. 33.7 months; HR = 0.42; 95% CI, 0.28-0.63).
A separate nonrandomized cohort of SEQUOIA included 110 patients with previously untreated CLL/SLL with 17p deletion. After median follow-up of 25.1 months, researchers reported an 88% (95% CI, 81-94) overall response rate. Median duration of response had not been reached.
The randomized ALPINE trial assessed efficacy of zanubrutinib for 652 patients with relapsed or refractory CLL or SLL (median prior therapies, 1; range, 1-8).
Researchers randomly assigned participants to zanubrutinib or ibrutinib (Imbruvica; Janssen, Pharmacyclics).
ORR and duration of response per independent review committee served as the main efficacy outcomes.
After median follow-up of 14.1 months, researchers reported an ORR of 80% (95% CI, 76-85) with zanubrutinib and 73% (95% CI, 68-78) with ibrutinib (response rate ratio = 1.1; 95% CI, 1.01-1.2). Median duration of response had not been reached in either group.
Safety analyses across trials showed the most common adverse events among zanubrutinib-treated patients included decreased neutrophil count (42%), upper respiratory tract infection (39%), decreased platelet count (34%), hemorrhage (30%) and musculoskeletal pain (30%).
Additionally, 13% of patients developed second primary malignancies, 3.7% reported atrial fibrillation or flutter, and 0.2% developed grade 3 or higher ventricular arrhythmias.
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