Primary Endpoint: Progression-Free Survival (28.3 Month Follow up)
Superior Progression-Free Survival with acalabrutinib-O compared to O-Clb1
- PFS: IRC-Assessed
- PFS: Investigator Assessed
- PFS: TP53 mutation
- PFS: del(17)(p13.1)
- PFS: IGHV mutation
IRC-Assessed Progression-Free Survival1
At 28.3-month median follow-up, the combination acala-O reduced the risk of progression or death by 90% vs. O-Clb1
Investigator-Assessed PFS 1
Investigator-assessed PFS was similar to IRC-assessed PFS1
IRC-Assessed PFS in Patients with TP53 Mutation1
Patients with TP53 mutations in the acala containing arms had a longer median estimated 24 month PFS versus patients treated with O-Clb1
IRC-Assessed PFS in Patients with Del(17)(p13.1)1
Patients with del 17p in the acala containing arms had a longer estimated median 24 month PFS versus patients treated with O-Clb1
IRC-Assessed PFS in Patients with IGHV mutation1
Estimated median 24-month PFS was longer in patients with unmutated and mutated IGHV treated with acala-O vs. O-Clb1
Efficacy was consistent across prespecified patient subgroups treated with acala containing arms vs O-Clb including age and high-risk genomic features such as del(17)(p13.1), unmutated IGHV, and complex karyotype1
IRC-Assessed PFS Benefit Consistent Across Subgroups1
IRC-Assessed PFS Benefit Consistent Across Subgroups1
Note: Prespecified subgroup definition for bulky disease (5 cm) was different than what is presented (10 cm).1
Abbreviations
Acala = acalabrutinib
;CI = confidence interval
;Clb = chlorambucil
;ECOG = Eastern Cooperative Oncology Group
;IGHV = immunoglobulin heavy-chain variable gene
;IRC = independent review committee
;NE = not estimable
;No. = number
;NR = not reached
;O = obinutuzumab
;PFS = progression-free survival
;TP53 = tumor protein p53
References
Document ID: 780f9b60-d375-4516-97d6-9ba58f025de4
Last updated: 17-April-2023