The PFS and OS for the subgroup with TP53 mut/del(17p) are particularly encouraging in reference to other trials of BTK inhibitors, maintaining 100% PFS and OS at ∼42 mos.

Efficacy in MCL...7 pts with TP53 mutation had ORR of 85.7% with mPFS NR and 14 pts with Ki-67 ≥30% had ORR of 85.7% with mPFS 33.2 mos. Overall, median OS was NR (95% CI: 22.46, NE)...Zilo+Ibr is well-tolerated with a safety profile that is comparable to Ibr alone. AF (all grades) occurred in 9.4% of all pts treated which appears lower than rate in Ibr alone studies. The combination is very promising in pts with RR MCL (ORR 89.3%, CR 42.9%, mPFS NR). For CLL pts with TP53 mut/del(17p), Zilo+Ibr is also very active, maintaining 100% PFS and OS at ∼42 mos.

...CLL pts in Parts 1 and 2 were high risk as determined by unmutated IGHV, del17p, and/or del11q…. best response of 17 evaluable pts in Parts 1 and 2 included an objective response rate (ORR) of 82%, 41% CR/CMR, 41% PR, 12% SD, and 6% PD. CR/CMR remain durable from 8-28+ mos. Most responses occurred rapidly after ̃3 mos of Cirm/Ibr....Cirm/Ibr is a well-tolerated, active regimen in both MCL and CLL.