Japan has approved AstraZeneca’s Calquence (acalabrutinib), for the treatment of adult patients with treatment-naïve Chronic Lymphocytic Leukaemia (CLL) (including small lymphocytic lymphoma [SLL]). Calquence was previously approved in Japan for the treatment of adults with relapsed or refractory CLL, a statement from AstraZeneca said.
It also said that the approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on positive results from two clinical trials, including the Elevate-TN phase-III trial in adults with treatment-naïve CLL. This trial showed that Calquence combined with obinutuzumab or as monotherapy demonstrated a significantly improved Progression-Free Survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab. Data from the interim analysis of Elevate-TN was published in The Lancet in 2020. Additionally, a phase-I trial in treatment-naïve Japanese patients with CLL was also submitted to MHLW supporting the approval, with the trial showing an overall response rate of 88.9 per cent (95 per cent CI: 63.2, 98.8 per cent) for Calquence alone and 100 per cent (95 per cent CI: 66.4, 100 per cent) for Calquence combined with obinutuzumab.
According to the statement, updated results of the Elevate-TN phase-III trial after a median follow-up of approximately five years were presented earlier this year. These results showed that Calquence maintained a statistically significant PFS benefit versus chlorambucil plus obinutuzumab, and a safety and tolerability profile consistent with the known profile for Calquence. At a median follow-up of 58.2 months, Calquence plus obinutuzumab reduced the risk of disease progression or death by 89 per cent (based on a hazard ratio [HR] of 0.11, 95 per cent confidence interval [CI] 0.07-0.16) and as a monotherapy by 79 per cent (based on a HR of 0.21, 95 per cent CI 0.15-0.30), compared with chlorambucil plus obinutuzumab.
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