Long-term follow-up of the RESONATE™ phase 3 trial of ibrutinib versus ofatumumab.
Ibrutinib, a once-daily oral inhibitor of Bruton's tyrosine kinase, has greatly improved outcomes for patients with chronic lymphocytic leukemia (CLL). The phase 3 RESONATE™, which compared single-agent ibrutinib to ofatumumab in high-risk, relapsed patients with CLL, provided support for approval of ibrutinib in the US and Europe. We describe long-term follow-up of patients treated in RESONATE, where continued superiority of progression-free survival (PFS) (hazard ratio [HR] 0.133; 95% CI, 0.099-0.178) was observed. Overall survival benefit continues (HR 0.591; 95% CI, 0.378-0.926), although with decreased magnitude relative to that seen before crossover to ibrutinib was implemented for patients on ofatumumab (HR 0.426; 95% CI, 0.220-0.823). Notably, overall response to ibrutinib increased over time with 91% of patients attaining a response. The PFS benefit with ibrutinib was independent of baseline risk factors, although patients with ≥2 prior therapies had shorter PFS than those withtherapies, and presence of
Byrd, John C; Hillmen, Peter; O'Brien, Susan; Barrientos, Jacqueline C; Reddy, Nishitha M; Coutre, Steven; Tam, Constantine S; Mulligan, Stephen P; Jaeger, Ulrich; Barr, Paul M; Furman, Richard R; Kipps, Thomas J; Thornton, Patrick; Moreno, Carol; Montillo, Marco; Pagel, John M; Burger, Jan A; Woyach, Jennifer A; Dai, Sandra; Vezan, Remus; James, Danelle F; and Brown, Jennifer R, "Long-term follow-up of the RESONATE™ phase 3 trial of ibrutinib versus ofatumumab." (2019). Articles, Abstracts, and Reports. 1306.