SUPERIOR EFFICACY VS BR IN FIRST LINE
AND VS IBRUTINIB IN SECOND LINE
First line
SUPERIOR PFS VS BR IN PATIENTS WITHOUT DEL(17p) AND CONSISTENT PFS
IN PATIENTS WITH DEL(17p)1,2
Cohort 2: The largest prospective study of 1L patients with del(17p)
In Cohort 1, median PFS was not yet reached in either arm at median follow-up of 26.2 months.2
The primary endpoint was PFS per IRC in the ITT population in the BRUKINSA arm and the BR arm, with minimum 2-sided alpha of 0.05 for superiority.2
IN PATIENTS WITHOUT DEL(17p):
PFS GENERALLY FAVORED BRUKINSA REGARDLESS OF MUTATION OR RISK STATUS*2
All subgroup analyses are exploratory and descriptive in nature.
*Assessed by IRC.
†Hazard ratio and 95% CI were from stratified (for all patients) or unstratified analysis (for subgroup) Cox regression model with BR arm as the reference group.
HIGH ORR IN PATIENTS WITH AND WITHOUT DEL(17p)1,2
Cohort 1: without del(17p)
secondary endpoint*
with BRUKINSA at ~2 years
(95% CI: 89.0, 96.0) vs 85%
with BR (95% CI: 80.0, 90.0)
Cohort 2: with del(17p)
secondary endpoint†
with BRUKINSA
(95% CI: 81.0, 94.0)
*Prespecified analysis assessed by IRC; median follow-up of 26.2 months.2
†Prespecified analysis assessed by IRC; median follow-up of 30.5 months.2
1L=first line; BR=bendamustine+rituximab; CI=confidence interval; CLL=chronic lymphocytic leukemia; ECOG PS=Eastern Cooperative Oncology Group performance status; HR=hazard ratio; IRC=independent review committee; ITT=intent to treat; ORR=overall response rate; PFS=progression-free survival.
For US prescribers, the value of this reprint (~$15) will be reported under the Sunshine Act after registering for access.
Second line
THE ONLY BTKi TO ACHIEVE SUPERIOR PFS VS Ibrutinib3
Median PFS has not yet been reached with BRUKINSA vs 34 months with ibrutinib*
Data presented are consistent with label.4
Statistical analysis for PFS was conducted for noninferiority. When noninferiority was met, superiority was tested.3
*Assessed by both IRC and investigator with similar results.3
CONSISTENT PFS VS IBRUTINIB,
REGARDLESS OF MUTATION OR RISK STATUS*3
All subgroup analyses are exploratory and descriptive in nature.
* Assessed by both IRC and investigator with similar results.
†Hazard ratio and 95% CI were unstratified for subgroups.
THE ONLY BTKi TO ACHIEVE SUPERIOR ORR
VS IBRUTINIB1
With BRUKINSA, 92% of patients sustained a response vs 86% with ibrutinib at 1 year
Statistical analysis for ORR was conducted for noninferiority. When noninferiority was met, superiority was tested.3
* Assessed by both IRC and investigator with similar results.1,3
CONSISTENT ORR VS IBRUTINIB,
REGARDLESS OF MUTATION OR RISK STATUS3
All subgroup analyses are exploratory and descriptive in nature.
Assessed by both IRC and investigator with similar results. Median follow-up of 24.7 months.1,3
2L=second line; BTKi=Bruton's tyrosine kinase inhibitor; CI=confidence interval; CR=complete response; ECOG PS=Eastern Cooperative Oncology Group performance status; HR=hazard ratio; IRC=independent review committee; nPR=nodular partial response; ORR=overall response rate; PFS=progression-free survival; PR=partial response.
For US prescribers, the value of this reprint (~$25) will be reported under the Sunshine Act after registering for access.
Dr Anthony Nguyen discusses
efficacy data across mutations
and risk status in CLL
DISCOVER MORE VIDEOS
Long-term data
Study 003:
A global supportive Phase 1/2, open-label, single-arm trial that included patients with treatment-naïve or relapsed/refractory CLL/SLL and evaluated ~4 years of safety and ~3 years of efficacy data5
BRUKINSA PROVIDED CONSISTENT PFS ACROSS LINES OF THERAPY AT ~3 YEARS5
Exploratory long-term analysis; all data are descriptive in nature.
*Assessed by IRC.
BRUKINSA PROVIDED CONSISTENT ORR across lines of therapy at ~3 years5
86% of patients had an ongoing response at 3 years, regardless of line of therapy
Exploratory long-term analysis; all data are descriptive in nature.
Study 003 was a global supportive Phase 1/2 trial for 1L and 2L CLL.
*Assessed by IRC.
1L=first line; 2L=second line; CI=confidence interval; CLL=chronic lymphocytic leukemia; CR=complete response; ORR=overall response rate; PFS=progression-free survival; PR=partial response; SLL=small lymphocytic lymphoma.
