BeiGene, Ltd...announced the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a final draft guidance (FDG) recommending BRUKINSA® (zanubrutinib) for the treatment of eligible adult patients with...Untreated chronic lymphocytic leukemia (CLL) if there is a 17p deletion or TP53 mutation (high risk) or...Relapsed or refractory CLL.

Suggested treatment regimens...CLL/SLL with del(17p)/TP53 mutation…First-line therapy…other recommended regimens...Zanubrutinib (for patients with contraindication to other BTKi).

Additionally, zanubrutinib was more favorable in high-risk del17p/TP53 mutation (18-mo landmark 80.0% vs. 64.3%; HR: 0.51; 95% CI 0.12-2.13). ORR also favored zanubrutinib over ibrutinib (87.2% vs. 76.7%; 95% CI 0.93-1.38) by IRC.

...patients with R/R CLL/SLL received oral zanubrutinib...Patients with del(17p) and/or TP53 mutation and del(11q) achieved high response rates of 91% (95% CI, 70.8%>98.9%) and 100% (95% CI, 83.2%>100%), respectively….Deep and durable responses were achieved in all patient subgroups including patients with high-risk cytogenetics. Data support the tolerability of long-term zanubrutinib treatment in R/R CLL/SLL, with no new safety signals identified.

Ninety-one patients (82 CLL, 9 SLL) enrolled in the study and received at least one dose of zanubrutinib....Subgroup analysis of ORR revealed results generally consistent with the overall study population, including in subgroups with poor prognostic features (e.g., IGHV unmutated status [82%], del(17p)/TP53 mutation [86%], and refractory disease [83%])...Responses were observed in 19 (86.4%) of 22 patients with either del(17p) or TP53 mutation...