ELEVATE-TN Phase III trial of Calquence + Gazyva shows PFS benefit in chronic lymphocytic leukaemia.- AstraZeneca
Updated results from the ELEVATE-TN Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) maintained a statistically significant progression-free survival (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 approximately five years in combination and as a monotherapy in chronic lymphocytic leukaemia (CLL).
Results also showed longer overall survival (OS) for Calquence combined with Gazyva obinutuzumab compared with chlorambucil combined with obinutuzumab in previously untreated adults with CLL. CLL is the most prevalent type of leukaemia in adults, with over 100,000 patients diagnosed globally in 2019.
At a median follow-up of 58.2 months, Calquence plus obinutuzumab reduced the risk of disease progression or death by 89% (based on a hazard ratio [HR] of 0.11, 95% confidence interval [CI] 0.07-0.16) and as a monotherapy by 79% (based on a HR of 0.21, 95% CI 0.15-0.30), compared with chlorambucil plus obinutuzumab. OS data are immature, and medians were not yet reached in any treatment arm. The relative risk for death was 45% lower in the Calquence plus obinutuzumab arm (based on a HR of 0.55, 95% CI 0.30-0.99). An estimated 90% of patients treated with the Calquence combination were alive at five years versus 84% for Calquence alone and 82% for chlorambucil plus obinutuzumab.
Separately, follow-up data from the ASCEND Phase III trial showed Calquence demonstrated a sustained PFS benefit at four years based on investigator assessment compared with investigator’s choice of rituximab combined with either idelalisib (IdR) or bendamustine (BR) in adults with relapsed or refractory CLL. At 42 months, an estimated 62% of patients treated with Calquence were alive and had not progressed in comparison with 19% of patients treated with IdR/BR. The median follow-up was 46.5 months for Calquence and 45.3 months for IdR/BR. The safety and tolerability of Calquence in the ELEVATE-TN and ASCEND trials were consistent with earlier findings, with no new safety signals identified. The results were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.
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