Table 2.
Summary of Confirmed ORRs Assessed According to RECIST Version 1.1by Blinded, Independent, Central Review in a Pooled Analysis of Patients With a PD‐L1 TPS < 1%
| Pembrolizumab + Chemotherapy (n = 256) | Chemotherapy Alone (n = 188) | |
|---|---|---|
| ORR a | ||
| No. of patients | 128 | 56 |
| % (95% CI) | 50.0 (43.7‐56.3) | 29.8 (23.4‐36.9) |
| Best overall response, No. (%) | ||
| Complete response | 2 (0.8) | 5 (2.7) |
| Partial response | 126 (49.2) | 51 (27.1) |
| Stable disease | 90 (35.2) | 79 (42.0) |
| Progressive disease | 20 (7.8) | 32 (17.0) |
| Not evaluable b | 11 (4.3) | 12 (6.4) |
| No assessment c | 7 (2.7) | 9 (4.8) |
| Time to response, median (range), mo | 1.6 (1.2‐26.3) | 1.4 (1.2‐26.9) |
| DOR, median (range), mo d | 8.5 (1.1+ to 46.0) | 6.9 (1.4+ to 30.1+) |
| Ongoing response, No. (%) e | 20 (15.6) | 9 (16.1) |
Abbreviations: DOR, duration of response; ORR, objective response rate; PD‐L1, programmed death ligand 1; RECIST, Response Evaluation Criteria in Solid Tumors; TPS, tumor proportion score.
Includes confirmed complete responses plus partial responses.
Includes patients with 1 or more postbaseline tumor assessments, none of which were evaluable for response, and those with a postbaseline tumor assessment less than 6 weeks from randomization showing a complete response, a partial response, or stable disease.
No postbaseline assessment was available for a response evaluation.
A plus sign indicates no progressive disease at the time of the last disease assessment.
Includes patients who were alive and had not progressed, initiated new anticancer treatment, or been lost to follow‐up with a last adequate assessment less than 5 months before the data cutoff date.