Additional Endpoints (28.3 Month Follow up)1 

Overall Response Rate

Superior ORR and higher rates of CR by IRC with acala-O over O-Clb1

IRC-Assessed Response Rates1

IRC-Assessed Response Rates1

aSix patients (3%) had unknown response, and one patient (1%) had a response of non-PD, defined as not having adequate CT or MRI data and not meeting criteria for PD by physical examination. 

bTwo patients (1%) had PR-L, three patients (2%) had PD, 12 patients (7%) had unknown response, and one patient’s (1%) response was not evaluable.

cTwo patients (1%) had non-PD, 12 patients (7%) had an unknown response, one patient (1%) had no evaluable disease, and eight patients’ (5%) responses were not evaluable.

Minimal Residual Disease

Rates of undetectable MRD in pts with CR or CRi were similar between acala-O and O-Clb1

MRD assessments in blood or bone marrow in patients with investigator-assessed CR/CRi1a

MRD assessments in blood or bone marrow in patients with investigator-assessed CR/CRi1a

aData presented is from peripheral blood or bone marrow; bFirst available MRD data point presented after first investigator-assessed CR/CRi.

MRD assessments
Patients with CR/CRi by Investigator Assessmenta − No. (%)1

Acala-O

(n=43)

Acala

(n=14)

O-Clb

(n=23)

MRD assessments (by flow cytometry)

Peripheral blood or bone marrow

  • Patients evaluable
33 (77)9 (64)15 (65)
  • MRD-negative
24 (56)1 (7)14 (61)
Peripheral blood
  • Patients evaluable
31 (72)9 (64)15 (65)
  • MRD-negative
21 (49)1 (7)14 (61)
Bone marrow
  • Patients evaluable
18 (42)7 (50)8 (35)
  • MRD-negative
11 (26)05 (22)
aFirst available MRD data point presented after first investigator-assessed CR/CRi.

Overall Survival

Median overall survival was not reached in any arm, yet 45 patients in the O-Clb arm crossed over to the acala monotherapy arm1

55 of 177 patients (31%) randomized to O-Clb had disease progression of which 82% (45/55) crossed over to receive acalabrutinib monotherapy1

Overall Survival1

Overall Survival1

Abbreviations

Acala = acalabrutinib

;

CI = confidence interval

;

Clb = chlorambucil

;

CR = complete response

;

CRi = CR with incomplete marrow recovery

;

CT = computed tomography

;

IRC = independent review committee 

;

MRD = minimal residual disease

;

MRI = magnetic resonance imaging

;

mo = months

;

O = obinutuzumab

;

ORR = overall response rate

;

OS = overall survival 

;

p = p-value

;

PD = progressive disease

;

PRL = partial response with lymphocytosis

;

pt = patient

;

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

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