Table 3.
Best real-world tumor response (rwTR) to first-line pembrolizumab monotherapy: Spotlight cohort.
| Spotlight a (n = 228) | KEYNOTE-024 b (n = 154) | |
|---|---|---|
| Complete response (CR) | 17 (7.5) | 7 (4.5) |
| Partial response (PR) | 71 (31.1) | 64 (41.6) |
| Stable disease | 34 (14.9) | 37 (24.0) |
| Progressive disease (PD) | 50 (21.9) | 35 (22.7) |
| No evaluable assessment | 56 (24.6) | 0 |
| Indeterminate | 1 (0.4) | – |
| Pseudoprogression c | 7 (3.1) | – |
| Not documented/no assessment | 51 (22.4) | 11 (7.1) |
Data are presented as n (%) of patients.
a
rwTR determination was based on changes in NSCLC tumor burden indicated by radiology reports. For patients with multiple rwTR assessments, the best response was used to classify the patient (CR>PR>stable disease>PD). Patients without an evaluable assessment (no CR, PR, stable disease, or PD) could be counted >1 time in the subcategories of “no evaluable assessment”.
b
KEYNOTE-024 results determined using RECIST 1.1 criteria by investigatory review (2).
c
Pseudoprogression was defined as an increase in tumor size that the clinician recorded as possibly being an effect of ICI therapy.