ALPINE Trial: Bruton’s Tyrosine Kinase Inhibitor in Resistant CLL
Posted: Friday, September 6, 2019
Peter Hillmen, PhD, of St. James University Hospital in the United Kingdom, and colleagues presented results from the ongoing ALPINE trial at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS7572) on a novel treatment of chronic lymphocytic leukemia (CLL). The trial focused on an inhibitor of Bruton’s tyrosine kinase (BTK), zanubrutinib, which has been engineered to optimize selectivity, half-life, and solubility.
This global phase III, randomized, open-label trial is aimed at comparing zanubrutinib with ibrutinib in patients with refractory or recurrent CLL and small lymphocytic lymphoma. The trial will recruit about 400 patients to be randomly assigned to receive one of the two drugs. Patients will also be stratified by age, refractory status, geographic region, and mutation of TP53. Other inclusion criteria include adequate hematologic function, a life expectancy of more than 6 months, and an Eastern Cooperative Oncology Group performance status of 0 to 2. Patients who have cardiovascular disease, a prior malignancy within the past 3 years, or prior treatment with a BTK inhibitor will be ineligible for the trial.
The primary endpoint of this trial will be overall response rate, with modifications for patients with treatment-related lymphocytosis in CLL or small lymphocytic lymphoma. The study will aim to test the noninferiority and superiority of the overall response rate for zanubrutinib compared with ibrutinib. Other endpoints will include progression-free survival, safety, duration of response, and overall survival. Recruitment is ongoing.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.