Table 2.
Clinical Activity of Anti–PD-L1 Antibody in the Efficacy Population.*
| Tumor Type and Dose | No. of Patients |
Objective Response† |
Duration of Response‡ |
Stable Disease ≥24 Weeks |
Rate of Progression- free Survival at 24 Weeks§ |
||
|---|---|---|---|---|---|---|---|
|
no. of patients |
% (95% CI) | mo |
no. of patients |
% (95% CI) | % (95% CI) | ||
| Melanoma | |||||||
| 0.3 mg/kg | 1 | 0 | 0 (0–98) | NA | 0 | 0 (0–98) | NA |
| 1 mg/kg | 18 | 1 | 6 (0–27) | 6.9 | 6 | 33 (13–59) | 39 (16–61) |
| 3 mg/kg | 17 | 5¶ | 29 (10–56) | 23.5+, 22.9+, 16.2+, 4.1+, 3.5 | 3 | 18 (4–43) | 47 (21–72) |
| 10 mg/kg | 16 | 3‖ | 19 (4–46) | 20.8+, 16.6, 2.8 | 5 | 31 (11–59) | 44 (19–68) |
| All doses | 52 | 9 | 17 (8–30) | 14 | 27 (16–41) | 42 (28–56) | |
| Non–small-cell lung cancer | |||||||
| All patients, 1 mg/kg | 11 | 0 | 0 (0–29) | NA | 0 | 0 (0–29) | NA |
| All patients, 3 mg/kg | 13 | 1 | 8 (0–36) | 2.3+ | 1 | 8 (0–36) | 34 (7–60) |
| Squamous subtype | 4 | 0 | 0 (0–60) | NA | 1 | 25 (0–81) | 50 (1–99) |
| Nonsquamous subtype | 9 | 1 | 11 (0–48) | ND | 0 | 0 (0–34) | 25 (0–55) |
| All patients, 10 mg/kg | 25 | 4 | 16 (5–36) | 16.6+, 12.6+, 9.8, 3.5 | 5 | 20 (7–41) | 46 (25–67) |
| Squamous subtype | 8 | 1 | 13 (0–53) | ND | 2 | 25 (3–65) | 47 (10–83) |
| Nonsquamous subtype | 17 | 3 | 18 (4–43) | ND | 3 | 18 (4–43) | 46 (20–72) |
| All patients, all doses | 49 | 5 | 10 (3–22) | 6 | 12 (5–25) | 31 (17–45) | |
| Squamous subtype | 13 | 1 | 8 (0–36) | ND | 3 | 23 (5–54) | 43 (15–71) |
| Nonsquamous subtype | 36 | 4 | 11 (3–26) | ND | 3 | 8 (2–23) | 26 (10–42) |
| Ovarian cancer | 1 | 0 | 0 (0–98) | NA | 0 | 0 (0–98) | NA |
| 3 mg/kg | 1 | 0 | 0 (0–98) | NA | 0 | 0 (0–98) | NA |
| 10 mg/kg | 16 | 1 | 6 (0–30) | 1.3+ | 3 | 19 (4–46) | 25 (4–46) |
| All doses | 17 | 1 | 6 (0–29) | 3 | 18 (4–43) | 22 (2–43) | |
| Renal-cell cancer, 10 mg/kg | 17 | 2 | 12 (2–36) | 17, 4 | 7 | 41 (18–67) | 53 (29–77) |
The efficacy population included 160 patients in whom a response could be evaluated and who initiated treatment by August 1, 2011. These patients had measurable disease at a baseline tumor assessment and at least one of the following: an assessment of tumor burden during the study, clinical progression, or death. NA denotes not applicable, and ND not determined.
Objective response rates (including both complete response and partial response) are based on confirmed responses only, with 95% confidence intervals calculated with the use of the Clopper–Pearson method.
The duration of response is the time from the first response to the time of documented disease progression, death, censoring of data (denoted by a plus sign), or last tumor assessment.
The rate of progression-free survival was the proportion of patients who did not have disease progression and were alive at 24 weeks, as calculated by the Kaplan–Meier method. The Greenwood method was used to calculate confidence intervals.
Two of these patients had a complete response.
One of these patients had a complete response.