Table 2.
Confirmed Tumor Responses.*
| End Point | pMMR Population | All Patients | dMMR Population | |||
|---|---|---|---|---|---|---|
| Lenvatinib plus Pembrolizumab (N = 346) | Chemotherapy (N = 351) | Lenvatinib plus Pembrolizumab (N = 411) | Chemotherapy (N = 416) | Lerivatiriib plus Pembrolizumab (N =65) | Chemotherapy (N =65) | |
| Objective response | ||||||
| No. of patients | 105 | 53 | 131 | 61 | 26 | 8 |
| Percent (95% CI) | 30.3 (25.5 to 35.5) | 15.1 (11.5 to 19.3) | 31.9 (27.4 to 36.6) | 14.7 (11.4 to 18.4) | 40 (28 to 53) | 12 (5 to 23) |
|
| ||||||
| Best overall response | ||||||
|
| ||||||
| Complete response | ||||||
| No. of patients | 18 | 9 | 27 | 11 | 9 | 2 |
| Percent (95% CI) | 5.2 (3.1 to 8.1) | 2.6 (1.2 to 4.8) | 6.6 (4.4 to 9.4) | 2.6 (1.3 to 4.7) | 14 (7 to 25) | 3 (<1 to 11) |
|
| ||||||
| Partial response | ||||||
| No. of patients | 87 | 44 | 104 | 50 | 17 | 6 |
| Percent (95% CI) | 25.1 (20.7 to 30.1) | 12.5 (9.3 to 16.5) | 25.3 (21.2 to 29.8) | 12.0 (9.1 to 15.5) | 26 (16 to 39) | 9 (3 to 19) |
|
| ||||||
| Stable disease | ||||||
| No. of patients | 168 | 139 | 193 | 167 | 25 | 28 |
| Percent (95% CI) | 48.6 (43.2 to 54.0) | 39.6 (34.4 to 44.9) | 47.0 (42.0 to 51.9) | 40.1 (35.4 to 45.0) | 38 (27 to 51) | 43 (31 to 56) |
|
| ||||||
| Progressive disease | ||||||
| No. of patients | 54 | 108 | 61 | 123 | 7 | 15 |
| Percent (95% CI) | 15.6 (11.9 to 19.9) | 30.8 (26.0 to 35.9) | 14.8 (11.5 to 18.7) | 29.6 (25.2 to 34.2) | 11 (4 to 21) | 23 (14 to 35) |
|
| ||||||
| Could not be evaluated† | ||||||
| No. of patients | 2 | 7 | 5 | 8 | 3 | 1 |
| Percent (95% CI) | 0.6 (0.1 to 2.1) | 2.0 (0.8 to 4.1) | 1.2 (0.4 to 2.8) | 1.9 (0.8 to 3.8) | 5 (1 to 13) | 2 (0 to 8) |
|
| ||||||
| Not assessed‡ | ||||||
| No. of patients | 17 | 44 | 21 | 57 | 4 | 13 |
| Percent (95% CI) | 4.9 (2.9 to 7.8) | 12.5 (9.3 to 16.5) | 5.1 (3.2 to 7.7) | 13.7 (10.5 to 17.4) | 6 (2 to 15) | 20 (11 to 32) |
|
| ||||||
| Median duration of response (range) — mo§ | 9.2 (1.6 to 23.7) | 5.7 (0.0 to 24.2) | 14.4 (1.6 to 23.7) | 5.7 (0.0 to 24.2) | NR (2.1 to 20.4) | 4.1 (1.9 to 15.6) |
|
| ||||||
| Median time to response (range) — mo | 2.1 (1.5 to 9.4) | 3.5 (1.0 to 7.4) | 2.1 (1.5 to 16.3) | 2.1 (1.0 to 7.4) | 2.9 (1.7 to 16.3) | 1.9 (1.8 to 3.7) |
|
| ||||||
| Disease control¶ | ||||||
| No. of patients | 248 | 163 | 296 | 194 | 48 | 31 |
| Percent (95% CI) | 71.7 (66.6 to 76.4) | 46.4 (41.1 to 51.8) | 72 (67.4 to 76.3) | 46.6 (41.8 to 51.6) | 74 (61 to 84) | 48 (35 to 60) |
NR denotes not reached.
A postbaseline assessment was available for these patients, but they could not be evaluated for response by the independent imaging vendor (e.g., owing to poor radiographic technique, poorly defined tumor margins, lesions that had been identified at screening not being imaged at a subsequent time point, or the lesion being obstructed by another body part and thus being unable to be measured or evaluated).
No postbaseline assessment was available for response evaluation.
Duration of response was assessed only in patients with a complete or partial response.
Disease control was defined as a best overall response of complete response, partial response, or stable disease at 7 weeks or more after randomization.