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AKT Inhibitor Capivasertib Focus of Phase II Trial in B-Cell NHL

By: Lauren Harrison, MS
Posted: Wednesday, May 4, 2022

A phase II study is enrolling patients with B-cell non-Hodgkin lymphoma (NHL) to test the efficacy and safety of capivasertib, a selective inhibitor of three AKT isoforms in the PI3K/AKT/mTOR pathway. Capivasertib has shown activity in vitro in a large panel of B-cell NHL lines and in vivo in mouse models, where it was able to downregulate MYC. Michael Wang, MD, of The University of Texas MD Anderson Cancer Center, presented the methods of this trial on behalf of his colleagues at the American Association for Cancer Research (AACR) Annual Meeting 2022 (Abstract CT127/10).

This trial (ClinicalTrials.gov identifier NCT05008055) aims to enroll a total of 272 patients into three different cohorts of relapsed or refractory disease—follicular lymphoma (1A), marginal zone lymphoma (1B), and mantle cell lymphoma (1C)—after two or more systemic lines of therapy. Patients with mutations in TP53, active central nervous system disease, diabetes requiring insulin, transformed follicular lymphoma, or who have received chimeric antigen receptor T-cell therapy in the past 3 months will be excluded. Patients will receive 480 mg of oral capivasertib twice a day on an intermittent schedule, 4 days on and 3 days off. Treatment will continue until disease progression or unacceptable toxicity.

The primary endpoint for the study will be objective response rate. Other endpoints will include duration of response, progression-free survival, overall survival, patient-reported outcomes, safety, and pharmacokinetics. When about 30 patients have been treated for 8 weeks across all cohorts, an interim safety analysis will be performed. There will be an interim efficacy analysis after 28 patients in cohorts 1A and 1B or after 24 patients in 1C have been treated for 4 months. The study is currently enrolling patients in 28 sites across 7 countries.

Disclosure: For a full list of authors’ disclosures, visit abstractsonline.com.


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