CALQUENCE Met Primary Efficacy Endpoint in Head-to-Head Trial Against ibrutinib in Chronic Lymphocytic Leukemia
Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s CALQUENCE (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for adults with previously treated, high-risk chronic lymphocytic leukemia (CLL) compared to ibrutinib.
The trial also met a key secondary endpoint for safety, showing patients treated with CALQUENCE had statistically significantly lower incidence of atrial fibrillation compared to patients treated with ibrutinib. Atrial fibrillation is an irregular heart rate that can increase the risk of stroke, heart failure and other heart-related complications.1 Further hierarchical testing revealed no difference for Grade 3 or higher infections or Richter’s transformation. There was a descriptive trend for numerically favorable overall survival. Overall, the safety and tolerability of CALQUENCE were consistent with the profile seen in the broader CALQUENCE clinical development program.
ELEVATE-RR is the first Phase III trial to compare two Bruton’s tyrosine kinase (BTK) inhibitors in patients with CLL, the most common type of leukemia in adults.2 Patients diagnosed with high-risk CLL may experience rapid worsening of their disease, requiring treatment.3
José Baselga, Executive Vice President, Oncology R&D, said: “With over forty months of follow-up, today’s results confirm that CALQUENCE, a selective BTK inhibitor, displays superior safety in atrial fibrillation without compromising efficacy. The totality of the data confirm our confidence in the favorable benefit-risk profile of CALQUENCE.”
The data will be presented at a forthcoming medical meeting and shared with health authorities.
INDICATION AND USAGE
CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
CALQUENCE is also indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE (acalabrutinib) capsules
Serious and Opportunistic Infections
Fatal and serious infections, including opportunistic infections, have occurred in patients with hematologic malignancies treated with CALQUENCE.