Patient Characteristics

Patient Demographics
Patient Disposition

Patient Demographics

Baseline demographics and disease characteristics, including high-risk features, were similar between groups¹

Baseline Demographics¹

Characteristic	Acala-O N = 179	Acalabrutinib N = 179	O-Clb N = 177
Age, median (range), y	70 (41–88)	70 (44–87)	71 (46–91)
Male sex	111 (62.0)	111 (62.0)	106 (59.9)
ECOG PS score
0–1	169 (94.4)	165 (92.2)	167 (94.4)
2	10 (5.6)	14 (7.8)	10 (5.6)
Bulky disease ≥5 cm	46 (25.7)	68 (38.0)	54 (30.5)
Rai stage
III	47 (26.3)	51 (28.5)	40 (22.6)
IV	38 (21.2)	37 (20.7)	38 (21.5)
Cytogenetic subgroup
Del(17p)	17 (9.5)	16 (8.9)	16 (9.0)
Del(17p) and/or mutated TP53	25 (14.0)	23 (12.8)	25 (14.1)
Del(11q)	31 (17.3)	31 (17.3)	33 (18.6)
Complex karyotype^a	29 (16.2)	31 (17.3)	32 (18.1)
Mutated TP53	21 (11.7)	19 (10.6)	21 (11.9)
Unmutated IGHV	103 (57.5)	119 (66.5)	116 (65.5)

Note: Twelve patients <65 years old did not meet eligibility criteria of having a CIRS-G score of >6 or creatinine clearance of 30-69 mL/min.

^aPatients with ≥3 cytogenetic abnormalities.

Patient Disposition

Patient Disposition²

Characteristic	Acala-O N = 179	Acalabrutinib N = 179	O-Clb N = 177
Treated with ≥1 dose of study drug	179 (100.0)	178 (99.4)	169 (95.5)
Randomized but not treated	0	1 (0.6)	8 (4.5)
Treatment status
Ongoing	134 (174.9)	124 (69.3)	0
Completed regimen	NA	NA	137 (77.4)
Discontinued regimen	45 (25.1)	55 (30.7)	40 (22.6)
Death	2 (1.1)^a	7 (3.9)^b	3 (1.7)^c
Adverse event	23 (12.8)	22 (12.3)	26 (14.7)
Lost to follow-up	0	1 (0.6)	1 (0.6)
CLL progressive disease	8 (4.5)	14 (7.8)	3 (1.7)
Withdrawal of consent	2 (1.1)	2 (1.1)	6 (3.4)
Investigator's discretion	5 (2.8)	6 (3.4)	0
Other	5 (2.8)^d	3 (1.7)^e	1 (0.6)^f
Treatment exposure, median (range), months	46.6 (2.3–58.6)	45.7 (0.3–59.3)	5.6 (0.9–7.4)

Notes: Data are n (%) unless otherwise specified; Median study follow-up was 46.9 months (range, 0.0–59.4 months).

^aDue to adverse event (n=2); ^bDue to adverse event (n=6) and cerebrovascular accident (n=1); ^cDue to adverse event (n=2) and car accident (n=1); ^dIncludes patient decision (n=2), treatment interruption due to disease improvement (n=1), treatment interruption >28 days (n=1), bleeding risk concerns with clopidogrel bisulfate and acetylsalicylic acid concomitant treatment (n=1); ^eIncludes patient decision (n=1), CML diagnosis (n=1), drug initially held due to macular edema and new lung cancer growth found at time of restart (n=1); ^fDid not meet eligibility criteria (post-randomization determination by sponsor; n=1).

Abbreviations

A = acalabrutinib

;

CIRS-G = Cumulative Illness Rating Scale-Geriatric

;

Clb = chlorambucil

;

CLL = chronic lymphocytic leukemia

;

ECOG-PS = Eastern Cooperative Oncology Group performance status

;

IGHV = immunoglobulin heavy-chain variable gene

;

NA = not applicable

;

O = obinutuzumab

;

TP53 = tumor protein p53

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.
2. Sharman J, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus obinutuzumab with chlorambucil in treatment-naive chronic lymphocytic leukemia: ELEVATE-TN 4-year follow-up [oral presentation]. Presented at: American Society of Clinical Oncology (ASCO) Virtual Annual Meeting; June 4-8, 2021. Chicago, IL. Abs 7509.

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