Targeted Oncology recently featured a discussion by Dr. Jennifer Brown, director of Dana Farber’s Chronic Lymphocytic Leukemia Center, on the interim results from the SEQUOIA Phase 3 trial. The trial was designed to investigate two drugs, venetoclax and zanubrutinib, to treat patients with newly diagnosed small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) who had not received prior treatment.

About SEQUOIA

Sequoia Phase 3 analyzed the safety and efficacy of zanubrutinib, Bruton’s tyrosine kinase inhibitor, in groups of patients, some with and some without deletion 17p. This deletion is associated with high-risk CLL.

Patients with the 17p deletion were initially administered zanubrutinib (Brukinsa) and then treated with venetoclax (Venclexta). The first evaluation took place three months after treatment with zanubrutinib. Patients will continue to receive the combination until disease progression, undetectable minimum residual disease status, which means a minimal amount of disease left after treatment, or severe toxicity.

Interim Results

Dr. Brown presented interim trial results at the annual meeting of the Hematology Society in December of 2021. Initially, eighty patients were enrolled in the trial. Among these patients, thirty-six were diagnosed with deletion 17p and treated with zanubrutinib. Of this group, thirty patients responded, which resulted in a response rate of 96.8%.

The complete response rate (CR) is defined as the disappearance of all target lesions. The CR was 14%. Dr. Brown explained that this is a moving target, as the CR rate is based upon the results of a bone marrow biopsy. There are still many patients who are scheduled for a bone marrow biopsy, and that will change the CR rate.

37% of these patients experienced a grade 3+ adverse event. All but three patients remained in treatment.