Table 2.
Tumour response assessed by IRRC per RECIST v1.1.
| Response | Main efficacy analysis population (n = 68) | Special-interest efficacy analysis population (n = 42) |
|---|---|---|
| Objective response rate | ||
| n (%) | 26 (38.2) | 13 (31.0) |
| 95% CI | 26.7–50.8 | 17.6–47.1 |
| Disease control rate | ||
| n (%) | 46 (67.6) | 23 (54.8) |
| 95% CI | 55.2–78.5 | 38.7–70.2 |
| Complete response, n (%) | 2 (2.9) | 1 (2.4) |
| Partial response, n (%) | 24 (35.3) | 12 (28.6) |
| Stable disease, n (%) | 20 (29.4) | 10 (23.8) |
| Progressive disease, n (%) | 18 (26.5) | 16 (38.1) |
| Non-evaluablea, n (%) | 4 (5.9) | 3 (7.1) |
| Median duration of response (95% CI), months | NR (NR–NR) | NR (NR–NR) |
| Response duration ≥6 months, % (95% CI) | 95.7 (72.9–99.4) | 90.9 (50.8–98.7) |
| Response duration ≥12 months, % (95% CI) | 95.7 (72.9–99.4) | 90.9 (50.8–98.7) |
CI confidence interval, IRRC independent radiological review committee, NR not reached, RECIST Response Evaluation Criteria in Solid Tumors.
aThree and two patients did not have tumour assessments in the main efficacy analysis population and the special-interest efficacy analysis population, respectively. One patient included in both populations had stable disease as the best response, but the time from first study treatment to tumour assessment date was 38 days, which was shorter than the protocol specified minimum time from baseline (≥42 days), and thus tumour response was downgraded to non-evaluable.