Patient Exposure

Patient Exposure (28.3 Month Follow up)¹

Treatment Discontinuations
Time to Next Treatment

Treatment Discontinuations

Despite the longer treatment duration in the acala-containing arms, the frequency of discontinuations due to AEs was not higher¹

Treatment Discontinuations¹

	Acala-O (N = 179)			O-Clb (N = 177)
Variable	Acala	O	Acala (n=179)	O	Clb
Duration of treatment, median (range), months^a	27.7 (25.0-32.8)	5.5 (5.5-5.6)	27.7 (24.8-33.0)	5.6 (5.5-5.9)	5.5 (5.5-5.7)
Discontinued regimen, n (%)	37 (20.7)		36 (20.1)	32 (18.1)
Adverse event	20 (11.2)		16 (8.9)	25 (14.1)
Lost to follow-up	0		1 (0.6)	1 (0.6)
CLL progressive disease	6 (3.4)		7 (3.9)	3 (1.7)
Withdrawal of consent	1 (0.6)		1 (0.6)	1 (0.6)
Investigator's decision	4 (2.2)		5 (2.8)	1 (0.6)
Other	4 (2.2)^b		3 (1.7)^c	0
AEs, n (%)
Leading to dose interruptions	60 (33.7)	18 (10.1)	28 (15.6)	21 (12.4)	37 (21.9)
Leading to dose reductions	14 (7.9)	-	5 (2.8)	-	48 (28.4)

^aContinuous acalabrutinib treatment resulted in a longer reporting period for Acala-O, and Acala vs O-Clb; ^bOther: patient decision (n=1), dose interruption >28 days (n=2; anemia and pneumonia), and risk of bleeding while taking aspirin and clopidogrel (n=1); ^cOther: patient decision (n=1), Richter transformation (n=1), and dose interruption >28 days (n=1; grade 4 thrombocytopenia).

Time to Next Treatment

A higher percentage of patients on O-Clb required a subsequent treatment versus patients on acalabrutinib regimens¹

Median time to next treatment was not reached in any group¹

Kaplan–Meier Assessments of Time to Next Treatment.¹

Hazard Ratio
Number at Risk

Hazard Ratio

Patients without a next treatment ¹

Hazard ratio (95% CI)
Acala-O vs O-Clb	0.14 (0.08, 0.26); p<0.0001
Acala vs O-Clb	0.24 (0.15, 0.40); p<0.0001

Hazard ratio (95% CI)

Acala-O vs O-Clb

0.14 (0.08, 0.26);

p<0.0001

Acala vs O-Clb

0.24 (0.15, 0.40);

p<0.0001

Number at Risk

Number at risk (number censored)¹

	0 mo	3 mo	6 mo	9 mo	12 mo	15 mo	18 mo	21 mo	24 mo	27 mo	30 mo	33 mo	36 mo	39 mo
Acala-O	179	178	175	172	168	165	164	162	160	115	73	45	13	3
Acala-O	(0)	(0)	(0)	(2)	(2)	(2)	(3)	(5)	(7)	(52)	(94)	(122)	(153)	(163)
Acala	179	172	169	165	162	160	159	157	151	110	72	46	15	4
Acala	(0)	(3)	(4)	(6)	(7)	(7)	(7)	(8)	(11)	(50)	(87)	(122)	(143)	(154)
O-Clb	177	166	160	158	155	148	131	116	107	71	37	27	9	2
O-Clb	(0)	(7)	(9)	(10)	(10)	(10)	(10)	(12)	(15)	(45)	(73)	(80)	(98)	(105)

Abbreviations

Acala = acalabrutinib

;

AE = adverse event

;

Clb = chlorambucil

;

CI = confidence interval

;

O = obinutuzumab

;

vs = versus

References

1. Sharman JP, Egyed M, Jurczak W et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzumab for treatment-nave chronic lymphocytic leukemia (ELEVATE TN): a randomized, controlled phase 3 trial [article and supplementary appendix]. Lancet. 2020;395:1278-91.

Document ID: 780f9b60-d375-4516-97d6-9ba58f025de4
Last updated: 17-April-2023