Discussion
chronic lymphocytic leukemia
CHRONIC LYMPHOCYTIC LEUKEMIA
The primary efficacy outcome of CR rate (83%) in this study shows statistically significant superiority of venetoclax and ibrutinib compared to ibrutinib monotherapy (historical CR rate of 12.5%) in Japanese patients with R/R MCL [Prior studies have demonstrated the efficacy of ibrutinib and venetoclax as single-agent monotherapy [Venetoclax exposures in combination with ibrutinib in this patient cohort was approximately 2.5-fold higher compared to exposures observed in Japanese patients with chronic lymphocytic leukemia receiving venetoclax monotherapy [Due to its potent anti-apoptotic effect, treatment with venetoclax carries risk of TLS [Despite the limitations of this study, including the small sample size and lack of a control group, the combination of ibrutinib and venetoclax demonstrated a clinically meaningful benefit in Japanese patients with R/R MCL. High CR rates and a tolerable safety profile with ibrutinib plus venetoclax were observed in elderly patients, representing a real-world population. The findings of this Phase 2 study reinforce the continued evaluation of the combination of ibrutinib and venetoclax, including the ongoing Phase 3 SYMPATICO study, for the treatment of R/R MCL.