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 | 0 | 2 (5) |
PR | 18 (44) | 18 (46) |
SD | 11 (27) | 9 (23) |
PD | 3‡ (7) | 0 |
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 | 0 | 2 (5) |
PR | 18 (44) | 18 (46) |
SD | 11 (27) | 9 (23) |
PD | 3‡ (7) | 0 |
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).