Table 3

ORR at the end of treatment

Patients, n (%)Obinutuzumab 1000 mg (n = 41)Obinutuzumab 2000 mg (n = 39)
ORR*(CR + CRi + PR) 20 (49) 26 (67) 
P 0.08 
CR 2 (5) 6 (15) 
CRi 2 (5) 
PR 18 (44) 18 (46) 
SD 11 (27) 9 (23) 
PD 3 (7) 
Not evaluable/missing§|| 7 (17) 4 (10) 
Patients, n (%)Obinutuzumab 1000 mg (n = 41)Obinutuzumab 2000 mg (n = 39)
ORR*(CR + CRi + PR) 20 (49) 26 (67) 
P 0.08 
CR 2 (5) 6 (15) 
CRi 2 (5) 
PR 18 (44) 18 (46) 
SD 11 (27) 9 (23) 
PD 3 (7) 
Not evaluable/missing§|| 7 (17) 4 (10) 

SD, stable disease.

*

ORR based on investigator-reported end-of-therapy response, which includes CT scan performed 51+ days from last obinutuzumab dose.

P value is 2-sided, based on stratified CMH test on ORR.

The 1000-mg arm: 2 of 3 patients were assessed as SD by the investigator at 50 and 49 days after last dose of obinutuzumab and had a subsequent response assessment with evidence of disease progression at 91 and 98 days after last dose of obinutuzumab, respectively.

§

Reasons for unevaluable patients in 1000-mg arm: no study treatment received (n = 1), death (n = 1), adverse event leading to discontinuation (n = 1), and concurrent metastatic squamous cell carcinoma (n = 1). In the 2000-mg arm: no study treatment received (n = 1) and adverse event leading to discontinuation (n = 1).

||

Patients classified as missing if no postbaseline response assessments were available or all postbaseline response assessments were performed <51 days from last obinutuzumab dose (1000-mg arm, n = 3; 2000-mg arm, n = 2).

Close Modal

or Create an Account

Close Modal
Close Modal