Patient Demographics

Patient Demographics

Demographics and baseline characteristics1
CharacteristicAcalabrutinib (n = 268)Ibrutinib (n = 265)
Age, median (range), years66 (41–89)65 (28– 88)
  • ≥75 years
44 (16.4)43 (16.2)
Male sex185 (69.0)194 (73.2)
ECOG PS score
  • 0–1
247 (92.2)243 (91.7)
  • 2
20 (7.5)22 (8.3)
Bulky disease ≥5 cm 128 (47.8)136 (51.3)
Rai stage 3 or 4131 (48.9)134 (50.6)
Cytogenetic abnormalities
  • del(17p)
121 (45.1)120 (45.3)
  • del(11q)
167 (62.3)175 (66.0)
  • Complex Karyotypea
124 (46.3)125 (47.2)
  • TP53 mutated
100 (37.3)112 (42.3)
  • IGHV unmutated
220 (82.1)237 (89.4)
No. of prior therapies, median (range)2 (1– 9)2 (1–12)
  • 1–3
234 (87.3)237 (89.4)
  • ≥4
33 (12.3)28 (10.6)

 Data are n (%) unless otherwise specified. 


aPatients with ≥3 chromosomal abnormalities.

Patient Disposition

Patient Disposition

Patient Disposition1
 Acalabrutinib (n = 268)Ibrutinib (n = 265)
Duration of follow-up, median (range), months41.1 (0.0–58.2)40.7 (0.2–59.1) 
Patients who received treatment265 (98.9)264 (99.6)a
Patients continuing to receive treatment at data cutoff124 (46.3)109 (41.1)
Patients who discontinued treatment141 (52.6)155 (58.5)

Reasons for treatment discontinuation

  • Disease progressionb
82 (30.6)68 (25.7)
  • Adverse event
40 (14.9)59 (22.3)
  • Consent withdrawn
7 (2.6)7 (2.6)
  • Death
5 (1.9)6 (2.3)
  • Investigator decision
5 (1.9)5 (1.9)
  • Other
2 (0.7)c10 (3.8)d

 Note: Data cutoff date: September 15, 2020 


aIncludes 1 patient who was randomized to ibrutinib but treated with acalabrutinib and was therefore included in the acalabrutinib arm for safety analyses; bDisease progression includes Richter’s transformation; cIncludes patients who discontinued treatment due to relocation (n=1) and starting therapy with ibrutinib (n=1) but agreed to remain on study for follow-up; dIncludes patients who discontinued treatment due to trial noncompliance (n=2), withdrawal of consent for treatment/follow-up but not considered withdrawal from study per electronic case report guidelines (n=1), refusal of medication (n=1), relocation (n=2), medical monitor decision (n=2), early termination due to second primary malignancy (n=1), and IRC- and medical monitor/sponsor-confirmed progressive disease but investigator disagreed and patient continued ibrutinib off-trial (n=1) but agreed to remain on study for follow-up.

Abbreviations

ECOG PS = Eastern Cooperative Oncology Group performance status

;

IGHV = immunoglobulin heavy chain variable region

;

No. = number

;

TP53 = tumor protein 53

References

1. Byrd JC, Hillmen P, Ghia P, et al. First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic lymphoma [oral presentation]. Presented at: American Society of Clinical Oncology (ASCO) Virtual Annual Meeting; June 4-8, 2021. Chicago, IL. Abstract 7500.

Document ID: b5f1a3c0-28eb-4186-8709-e3ddba7b6695
Last updated: 17-April-2023