Acalabrutinib Receives Chinese Approval in Mantle Cell Lymphoma

China’s National Medical Products Administration has conditionally approved acalabrutinib (Calquence) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least 1 prior line of therapy, according to a press release from AstraZeneca.¹

This approval of [acalabrutinib] in China can provide a new treatment option which can better benefit patients with [MCL]," according to an expert from Peking University Hospital, Beijing.

This conditional approval for acalabrutinib in China was supported by findings from 2 clinical trials, including the phase 2 ACE-LY-004 trial (NCT02213926), which evaluated the agent in patients with relapsed or refractory MCL, and a phase 1/2 trial (NCT03932331) in Chinese patients with relapsed or refractory MCL and other B-cell malignancies.

With a median follow-up of 15.2 months in the ACE-LY-004 trial, the investigator-assessed overall response rate (ORR) was 80.6% (95% CI, 72.6%-87.2%) with a complete response (CR) rate of 39.5% (95% CI, 30.9%-48.7%) for patients who received acalabrutinib. At a longer follow-up of 38.1 months, the median progression-free survival was 22 months, and the median overall survival was 59.2 months (95% CI, 36.5-not estimated).

In the phase 1/2 trial which was conducted in China, patients receiving acalabrutinib had an ORR of 82.4% (95% CI, 65.5%-93.2%), which included a CR rate of 35.3%. Additionally, acalabrutinib yielded a 51.5% (95% CI, 33.3%-67.0%) reduction in the risk of disease progression or death at 12 months. The estimated duration of response (DOR) was 65.5% (95% CI, 66.6%-93.3%), and the median DOR was not reached.

The safety and tolerability of acalabrutinib in these trials were consistent with profiles previously reported of the agent.

“The next generation [Bruton tyrosine kinase] inhibitor [acalabrutinib] has higher target selectivity, fewer [adverse] effects, and a higher response rate compared with currently available treatments,” Jun Zhu, MD, PhD, chief physician in the Department of Lymphatic Oncology at Peking University Cancer Hospital, Beijing, said in the press release. “This approval of [acalabrutinib] in China can provide a new treatment option which can better benefit patients with this disease.”

The FDA previously approved acalabrutinib in tablet formulation for patients with relapsed or refractory MCL, chronic lymphocytic leukemia, and small lymphocytic leukemia in August 2022.² The approval was supported by data from the ELEVATE-PLUS trials, which included 3 phase 1 open-label, single-dose crossover studies where investigators determined that acalabrutinib tablet formulations had similar efficacy and safety profile expectations as capsule formulations.

The FDA granted accelerated approval to acalabrutinib for the treatment of adult patients with MCL following at least 1 prior line of therapy in October 2017.³ The approval was supported by data from the phase 2 ACE-LY-004 trial.

References

1. Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma. News release. AstraZeneca. March 23, 2023. Accessed March 24, 2023. bit.ly/42uIQPs
2. Calquence tablet formulation approved in the US across current indications. News release. AstraZeneca. August 5, 2022. Accessed March 24, 2023. https://bit.ly/3Q3i1eG
3. FDA grants accelerated approval to acalabrutinib for mantle cell lymphoma. News release. FDA. October 31, 2017. Accessed March 24, 2023. bit.ly/40PWbAv