Calquence (acalabrutinib), given as a first-line treatment to patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), showed an acceptable safety profile and reduced tumor burden in 97 percent of patients in a Phase 1/2 clinical trial, AstraZeneca and Acerta Pharma announced.
Responses were long-lasting, with 98% of responders reaching the three-year mark without signs of disease progression.
The study, “Acalabrutinib in Treatment-Naive (TN) Chronic Lymphocytic Leukemia (CLL): Updated Results from the Phase 1/2 ACE-CL-001 Study,” was presented in December at the American Society of Hematology (ASH) 2018 Annual Meeting.
CLL/SLL occurs when B-cells, a type of immune cell, transform into cancer cells and grow too much. Calquence can bind to and inhibit the Bruton tyrosine kinase protein, which can help drive the growth of these cells. By blocking this growth-inducing signal, the drug helps control cancer growth and even kill cancer cells.
The medicine has received accelerated approval by the U.S. Food and Drug Administration for patients with mantle cell lymphoma who received at least one prior treatment.
The ACE-CL-001 trial (NCT02029443) is investigating Calquence as a treatment for CLL/SLL patients, including those who have never received a treatment for the condition and those who did.
Researchers already have reported a 95% response rate among patients who failed prior treatments. Now, they are reporting new data from the group of patients who received Calquence as a first-line treatment.
The study included 99 patients with CLL/SLL who had not received prior treatment. They were given Calquence daily and were monitored for the development of side effects and progression of disease.
After a median follow-up of 42 months, 97% of patients responded to the treatment in some way; 5% of patients had complete responses and 92% had partial responses. After three years, 98% of patients were still responding to Calquence and 97% were progression-free.
The treatment was well-tolerated overall. The most common adverse side effects included diarrhea, headache, infections in the upper respiratory tract, contusion, joint pain, weight gain, nausea, and cough. Five percent of the patients discontinued treatment due to side effects and one patient died due to pneumonia, which was deemed unrelated to Calquence.
“A key challenge in the treatment of CLL is ensuring patients have therapies that they can tolerate and benefit from over the long term,” John C. Byrd, MD, said in a press release. Byrd is Distinguished University Professor, Ohio State University, and principal investigator for the ACE-CL-001 CLL clinical trial.
“The results seen in this patient [group] at 3.5 years of follow-up are encouraging for both durability of response and tolerability of therapy. We look forward to continued data from ongoing studies evaluating acalabrutinib in CLL,” he said.