RESONATE-2
RESONATE-2 showed that the oral BTK inhibitor ibrutinib kept untreated chronic lymphocytic leukaemia in check far longer than the old chemotherapy tablet chlorambucil in older patients, and helped them live longer, which brought targeted pills into first-line treatment of this leukaemia.
Overview
RESONATE-2 was an open-label phase 3 trial in patients aged 65 or older with previously untreated chronic lymphocytic leukaemia or small lymphocytic lymphoma, excluding those with 17p deletion. Patients were randomised to continuous ibrutinib or to chlorambucil, the chemotherapy standard for older patients at the time.
Ibrutinib significantly prolonged progression-free survival, the primary endpoint assessed by an independent review committee, and improved overall survival and response rates. The result led to approval of ibrutinib for first-line CLL in the United States in March 2016 and made continuous BTK inhibition a standard first treatment; long-term follow-up has confirmed durable disease control. Later trials (ELEVATE-TN, SEQUOIA) extended the approach to second-generation inhibitors.
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