Table 3.
Responses for patients with measurable disease by arms.
| Cohort 1 | Arm A | Exp A | Arm B | Exp B | Arm C | Exp C | ||
|---|---|---|---|---|---|---|---|---|
| CDS | CDS | CDS | R-SDS | R-SDS | A-SDS | A-SDS | ||
| Response criteria, n (%) | (n = 3) | (n = 10) | (n = 4) | (n = 10) | (n = 3) | (n = 10) | (n = 4) | All patients (N = 44) |
| Confirmed ORR per RECIST 1.1 (95% CI) | 1 (33.3) (0.8–90.6) | 0 (0.0–30.9) | 0 (0.0–60.2) | 1 (10.0) (0.3–44.5) | 1 (33.3) (0.8–90.6) | 0 (0.0–30.9) | 0 (0.0–60.2) | 3 (6.8) (1.4–18.7) |
| PR (95% CI) | 1 (33.3) (0.8–90.6) | 0 (0.0–30.9) | 0 (0.0–60.2) | 1 (10.0) (0.3–44.5) | 1 (33.3) (0.8–90.6) | 0 (0.0–30.9) | 0 (0.0–60.2) | 3 (6.8) (1.4–18.7) |
| SD (95% CI) | 0 (0.0–70.8) | 3 (30.0) (6.7–65.3) | 0 (0.0–60.2) | 4 (40.0) (12.2–73.8) | 0 (0.0–70.8) | 5 (50.0) (18.7–81.3) | 2 (50.0) (6.8–93.2) | 14 (31.8) (18.6–47.6) |
| PD (95% CI) | 2 (66.7) (9.4–99.2) | 7 (70.0) (34.8–93.3) | 4 (100.0) (39.8–100.0) | 4 (40.0) (12.2–73.8) | 2 (66.7) (9.4–99.2) | 5 (50.0) (18.7–81.3) | 1 (25.0) (0.6–80.6) | 25 (56.8) (41.0–71.7) |
| Missing or unevaluable | 0 | 0 | 0 | 1 (10.0) | 0 | 0 | 1 (25.0) | 2 (4.5) |
| ORR per mRECIST (95% CI) | 1 (33.3) (0.8–90.6) | 0 (0.0–30.9) | 0 (0.0–60.2) | 1 (10.0) (0.3–44.5) | 1 (33.3) (0.8–90.6) | 0 (0.0–30.9) | 0 (0.0–60.2) | 3 (6.8) (1.4–18.7) |
| PSA response rate (95% CI) | 1 (33.3) (0.8–90.6) | 0 (0.0–30.9) | 0 (0.0–60.2) | 1 (10.0) (0.3–44.5) | 0 (0.0–70.8) | 0 (0.0–30.9) | 0 (0.0–60.2) | 2 (4.5) (0.6–15.5) |
| ALP response rate (95% CI) | 1 (33.3) (0.8–90.6) | 4 (40.0) (12.2–73.8) | 2 (50.0) (6.8–93.2) | 5 (50.0) (18.7–81.3) | 3 (100.0) (29.2–100.0) | 5 (50.0) (18.7–81.3) | 1 (25.0) (0.6–80.6) | 21 (47.7) (32.5–63.3) |
Abbreviations: A-SDS, atezolizumab run-in staggered dosing schedule; CDS, concurrent dosing schedule; R-SDS, radium-223 run-in staggered dosing schedule.