Efficacy outcomes by IRC assessment for Cohorts 2, 4, and pooled Cohorts 2 and 4 (Full Analysis Set)
| Response (RECIST V.1.1)* | Cohort 2 (n=66) | Cohort 4 (n=87) | Pooled Cohorts 2+4 (N=153) |
| ORR, n (%) | 23 (34.8) | 25 (28.7) | 48 (31.4) |
| (95% CI) | (23.5 to 47.6) | (19.5 to 39.4) | (24.1 to 39.4) |
| Best overall response, n (%) | |||
| CR | 5 (7.6) | 3 (3.4) | 8 (5.2) |
| PR | 18 (27.3) | 22 (25.3) | 40 (26.1) |
| SD | 24 (36.4) | 47 (54.0) | 71 (46.4) |
| Non-CR/non-PD† | 1 (1.5) | 0 | 1 (0.7) |
| PD | 15 (22.7) | 12 (13.8) | 27 (17.6) |
| Non-evaluable‡ | 3 (4.5) | 3 (3.4) | 6 (3.9) |
| Median DOR,§ months (range) | NR (1.4+ to 45.0+)¶ | 10.4 (1.4+ to 26.3+) | NR (1.4+ to 45.0+) |
| Median study follow-up,** months | 36.6 | 23.5 | 27.6 |
*Objective response refers to patients with the best overall response of CR and PR. 95% CI for ORR was calculated using the Clopper-Pearson exact test.
†Patient did not have measurable target lesions by IRC and had best overall response of non-CR/non-PD per IRC assessment.
‡Six patients were non-evaluable for response (five due to early death; one due to new anticancer therapy).
§Based on responders and using Kaplan-Meier product-limit estimates.
¶Note: + refers to censored.
**Based on the reverse Kaplan-Meier method.
CR, complete response; DOR, duration of response; IRC, independent review committee; NR, not reached; ORR, objective response rate; PD, progressive disease; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease.