response rate was 58% in patients refractory to fludarabine and alemtuzumab (see Table 1 for a summary of the efficacy data from the study). Patients who had prior rituximab therapy, either as monotherapy or in combination with other medicinal products, responded to treatment with ofatumumab at a similar rate as those who had not had prior rituximab therapy.
Table 1. Summary of response to Arzerra in patients with CLL
(Primary) endpoint 1
Patients refractory to fludarabine and alemtuzumab
n = 59
Overall response rate
Responders, n (%)
34 (58)
99% CI (%)
40, 74
Response rate in patients with prior rituximab therapy
Responders, n (%)
19/35 (54)
95% CI (%)
37, 71
Response rate in patients with chromosomal abnormality
17p deletion
Responders, n (%)
7/17 (41)
95% CI (%)
18, 67
11q deletion
Responders, n (%)
15/24 (63)
95% CI (%)
41, 81
Median overall survival
Months
13.7
95% CI
9.4, non-estimable
Progression-free survival
Months
5.7
95% CI
4.5, 8.0
Median duration of response
Months
7.1
95% CI
3.7, 7.6
Median time to next CLL therapy
Months
9.0
95% CI
7.3, 10.7
1 The overall response was assessed by an Independent Response Committee using the 1996 National Cancer Institute Working Group (NCIWG) guidelines for CLL.
Improvements also were demonstrated in components of the NCIWG response criteria. These included improvements associated with constitutional symptoms, lymphadenopathy, organomegaly, or cytopenias (see Table 2).
Table 2. Summary of clinical improvement with a minimum duration of 2 months in subjects with abnormalities at baseline
Efficacy endpoint or haematological parametera
Subjects with benefit/subjects with abnormality at baseline (%)
Patients refractory to fludarabine and alemtuzumab
Lymphocyte count
50% decrease
31/42 (74)
Normalisation (4x109/l)
20/42 (48)
Complete resolution of constitutional symptomsb
15/31 (48)
Lymphadenopathyc
50% improvement
34/55 (62)
Complete resolution
9/55 (16)
Splenomegaly
50% improvement
16/30 (53)
Complete resolution
14/30 (47)
Hepatomegaly
50% improvement
11/18 (61)
Complete resolution
9/18 (50)
Haemoglobin <11 g/dl at baseline to >11 g/dl post baseline
8/26 (31)
Platelet counts <100x109/l at baseline to >50% increase or >100x109/l post baseline
12/29 (41)
Neutrophils <1x109/l at baseline to 1.5x109/l
1/19 (5)
a Excludes subject visits from date of first transfusion, treatment with erythropoietin, or treatment with growth factors. For subject |
