AstraZeneca's Calquence meets primary endpoint in Phase III trial for untreated leukemia
AstraZeneca announced that its Calquence (acalabrutinib) Phase III ELEVATE-TN trial met its primary endpoint. The drug, alone or in combination, significantly improved progression-free survival in previously untreated chronic lymphocytic leukemia patients.
AstraZeneca has reported positive results from the Phase III ELEVATE-TN trial for Calquence (acalabrutinib) in patients with previously untreated chronic lymphocytic leukemia (CLL), the most common leukemia in adults. This marks the second pivotal trial for Calquence in CLL to meet its primary endpoint early.
The trial met its primary endpoint, demonstrating that Calquence in combination with obinutuzumab showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the chemotherapy-based combination of chlorambucine and obinutuzumab. Additionally, a key secondary endpoint was met, showing that Calquence monotherapy achieved a statistically significant and clinically meaningful improvement in PFS compared to the chemotherapy and obinutuzumab regimen.
The safety and tolerability profile of Calquence remained consistent with its established profile. José Baselga, Executive Vice President, Oncology R&D at AstraZeneca, stated that these findings confirm the superiority of Calquence, both as a monotherapy and in combination, over standard-of-care treatments for CLL. The company plans to present detailed results from ELEVATE-TN at an upcoming medical meeting.
AstraZeneca also plans to present full results from the Phase III ASCEND trial, which evaluates Calquence in relapsed or refractory CLL, at the upcoming European Hematology Association (EHA) Annual Congress. Calquence is currently approved in the U.S. and other countries for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).