Table 2. Antitumor Activity of Mobocertiniba.
| Outcome | No. (%) | |
|---|---|---|
| PPP cohort (n = 114) | EXCLAIM cohort (n = 96) | |
| IRC-assessed confirmed objective responseb | ||
| Patients, No. (%) [95% CI] | 32 (28) [20-37] | 24 (25) [17-35] |
| Complete response | 0 | 0 |
| Partial response | 32 (28) | 24 (25) |
| Stable diseasec | 57 (50) | 49 (51) |
| Not evaluable | 12 (11) | 10 (10) |
| Confirmed disease control rate, No. (%) [95% CI]d | 89 (78) [69-85] | 73 (76) [66-84] |
| Investigator-assessed confirmed objective response b | ||
| Patients, No. (%) [95% CI] | 40 (35) [26-45] | 31 (32) [23-43] |
| Complete response | 1 (<1) | 1 (1) |
| Partial response | 39 (34) | 30 (31) |
| Stable diseasec | 49 (43) | 41 (43) |
| Not evaluable | 11 (10) | 9 (9) |
| Confirmed disease control rate, No. (%) [95% CI]d | 89 (78) [69-85] | 72 (75) [65-83] |
| Duration of response in confirmed responderse | ||
| IRC-assessed | ||
| No. | 32 | 24 |
| Median (95% CI), mo | 17.5 (7.4-20.3) | NR (5.6-NR) |
| Investigator-assessed | ||
| No. | 40 | 31 |
| Median (95% CI), mo | 11.2 (5.6-NR) | 11.2 (7.0-NR) |
| Progression-free survival, median (95% CI), moe | ||
| No. | 114 | 96 |
| IRC-assessed | 7.3 (5.5-9.2) | 7.3 (5.5-9.1) |
| Investigator-assessed | 7.3 (5.6-8.8) | 7.3 (5.6-9.1) |
| Overall survival, median (95% CI), mo | ||
| No. | 114 | 96 |
| Median (95% CI), mo | 24.0 (14.6-28.8) | NR (13.1-NR) |
Abbreviations: IRC, independent review committee; NR, not reached; PPP, platinum-pretreated patients; RECIST, Response Evaluation Criteria in Solid Tumors.
a
Data cutoff date: November 1, 2020.
b
Objective response by RECIST version 1.1.
c
Stable disease observed 6 weeks or longer after first study drug administration.
d
Disease control rate is defined as the proportion of patients who have confirmed complete response or partial response, or best response of stable disease for 6 weeks or longer after initiation of study drug using RECIST version 1.1.
e
Duration of response, progression-free survival, and overall survival were estimated using Kaplan-Meier methods.