Table 2.
Efficacy outcomes
| CRC | Non-CRC | Overall study population (N = 103) |
|||||
|---|---|---|---|---|---|---|---|
| ≥ 2 Prior therapies (N = 41) | 1 Prior therapy (N = 24) | Total (N = 65) |
GC (N = 18) |
Other solid tumors (N = 20) |
Total (N = 38) |
||
| BIRC | |||||||
| ORR | |||||||
| n (%) | 13 (31.7) | 15 (62.5) | 28 (43.1) | 8 (44.4) | 8 (40.0) | 16 (42.1) | 44 (42.7) |
| 95% CI | 18.1–48.1 | 40.6–81.2 | 30.8–56.0 | 21.5–69.2 | 19.1–63.9 | 26.3–59.2 | 33.0–52.8 |
| DCR | |||||||
| n (%) | 24 (58.5) | 16 (66.7) | 40 (61.5) | 15 (83.3) | 13 (65.0) | 28 (73.7) | 68 (66.0) |
| 95% CI | 42.1–73.7 | 44.7–84.4 | 48.6–73.3 | 58.6–96.4 | 40.8–84.6 | 56.9–86.6 | 56.0–75.1 |
| DoR | |||||||
| Range, months | 1.05 + to 16.59 + | 2.76 + to 14.98 + | 1.87 to 14.98 + | 1.05 + to 16.59 + | 3.75 + to 14.72 + | 1.05 + to 16.59 + | 1.05 + to 16.59 + |
|
≥ 12 months, % (95% CI) |
74.6 (39.8–91.1) |
100.0 (100.0–100.0) |
88.4 (68.0–96.1) |
100.0 (100.0–100.0) |
100.0 (100.0–100.0) |
100.0 (100.0–100.0) |
92.2 (77.5–97.4) |
| PFS | |||||||
| Median (95% CI), months | 4.9 (1.9–9.9) | NR (1.8–NE) | 7.2 (3.5–NE) | NR (11.1–NE) | NR (1.9–NE) | NR (5.5–NE) | 11.1 (5.5–NE) |
| Range, months | 0.85 to 16.76 + | 0.76 to 18.27 + | 0.76 to 18.27 + | 1.41 to 18.43 + | 0.03 + to 16.62 + | 0.03 + to 18.43 + | 0.03 + to 18.43 + |
|
% at 12 months (95% CI) |
32.1 (18.1–47.0) | 62.5 (40.3–78.4) | 43.7 (31.2–55.4) | 58.0 (18.3–84.0) | 52.6 (28.7–71.9) | 57.7 (37.3–73.5) | 48.5 (37.8–58.3) |
| OS | |||||||
| Median (95% CI), months | NR (10.3–NE) | NR (NE–NE) | NR (NE–NE) | NR (NE–NE) | NR (5.9–NE) | NR (NE–NE) | NR (NE–NE) |
|
% at 12 months (95% CI) |
64.7 (47.7–77.4) | 87.1 (65.2–95.7) | 72.9 (60.1–82.2) | 83.3 (56.8–94.3) | 75.0 (50.0–88.7) | 78.9 (62.1–88.8) | 74.6 (64.7–82.1) |
CRC with ≥ 2 prior therapies included patients previously treated with a fluoropyrimidine-, oxaliplatin-, and irinotecan-containing regimen
CRC with 1 prior therapy included patients previously treated with a fluoropyrimidine- and oxaliplatin- or fluoropyrimidine- and irinotecan-containing regimen
BIRC, blinded independent review committee; CI, confidence interval; CRC, colorectal cancer; DCR, disease control rate; DoR, duration of response; GC, gastric cancer; NE, not evaluable; NR, not reached; ORR, objective response rate; OS, overall survival; PFS, progression-free survival
*For ORR, DCR, and DoR, each complete response and partial response as the best overall response was confirmed 4 weeks later (per RECIST Version 1.1)
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