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In ELEVATE-TN, acalabrutinib, a second-generation BTK inhibitor, with or without an antibody, cut the risk of progression by 80-90% compared with chlorambucil-obinutuzumab in older or unfit patients with CLL.
ELEVATE-TN was a three-arm phase 3 trial of 535 treatment-naive patients aged 65 or older, or younger with comorbidities. Patients were randomised to acalabrutinib plus obinutuzumab, acalabrutinib monotherapy, or chlorambucil plus obinutuzumab; the primary endpoint was PFS for the combination versus chemo-immunotherapy. At a median follow-up of 28.3 months median PFS was not reached in either acalabrutinib arm versus 22.6 months with chemo-immunotherapy, with hazard ratios of 0.10 for the combination and 0.20 for monotherapy. Acalabrutinib caused less atrial fibrillation and bleeding than reported with ibrutinib, and the trial supported its front-line approval.
ELEVATE-TN put a more selective BTK inhibitor into first-line CLL and, with the head-to-head ELEVATE-RR trial, showed it is as effective as ibrutinib with fewer cardiac side effects. Continuous acalabrutinib became one of the two main front-line options alongside fixed-duration venetoclax combinations. The trade-off is indefinite therapy and cost versus a time-limited course.
Shares SEQUOIA, Zanubrutinib, Acalabrutinib, BTK (Bruton tyrosine kinase).
Shares Acalabrutinib, Obinutuzumab, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment.
Shares Acalabrutinib, Obinutuzumab, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment.
Shares Zanubrutinib, Acalabrutinib, Chronic lymphocytic leukaemia, first treatment, Ibrutinib.
Shares Zanubrutinib, Acalabrutinib, Obinutuzumab, Chronic lymphocytic leukaemia, first treatment.
Shares Acalabrutinib, BTK (Bruton tyrosine kinase), Chronic lymphocytic leukaemia, first treatment, Ibrutinib.
Shares Acalabrutinib, Obinutuzumab, Chronic lymphocytic leukaemia, first treatment, Chronic lymphocytic leukaemia.
Shares SEQUOIA, Zanubrutinib, Chronic lymphocytic leukaemia, first treatment, Chronic lymphocytic leukaemia.