Data from the phase 3 ASCEND trial and a phase 1/2 trial support the National Medical Products Administration’s approval of acalabrutinib in China as a treatment for chronic lymphocytic leukemia.
The National Medical Products Administration has granted approval to acalabrutinib (Calquence) as a treatment for patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) in China, according to a press release from AstraZeneca.1
Findings from the phase 3 ASCEND trial (NCT02970318) and a phase 1/2 trial (NCT03932331) supported the approval of acalabrutinib in this indication.
In the ASCEND trial, investigators reported that 88% of patients who received acalabrutinib were alive and progression-free at 12 months compared with 68% of patients who received investigator’s choice of rituximab (Rituxan) plus idelalisib (Zydelig) or bendamustine. Additionally, data from a 42-month analysis highlighted that 62% and 19% of patients in each respective treatment group were alive and progression-free.
Results from the phase 1/2 trial highlighted an overall response rate of 83.3% in those receiving acalabrutinib. Investigators reported that the median progression-free survival (PFS) was not reached and that the PFS rate was 90.7% at 12 months and 78.8% at 18 months after a median follow-up of 20.2 months.
Safety data from both trials were comparable with previous reports of acalabrutinib in this patient population.
“Many people living with [CLL] experience relapse and need additional treatment options to help manage their disease,” Li Jianyong, professor and director of Haematology at People’s Hospital of Jiangsu Province and leader of the China CLL Working Group, said in the press release. “I’m delighted that with this approval patients now have access to an established treatment that has already demonstrated effectiveness in many patients across the globe.”
The FDA approved acalabrutinib as a treatment for patients with CLL or SLL in November 2019.2 The agency based its approval on PFS data from the ASCEND trial and the phase 3 ELEVATE-TN trial (NCT02475681).
“Today’s approval is another step towards our goal of making [acalabrutinib] available to as many patients as possible and offering physicians a treatment option with a well-established efficacy and tolerability profile,” Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, concluded.1