Table 1.
Target lesion response and ORR per RECIST v1.1 in the postprogression period among patients who were TBP and among all patients with PD in their parent trial
| Patients Who Were TBP |
All Patients With PD |
|||
|---|---|---|---|---|
| Indication (study name) | Target Lesion Response, % (n/N)a | ORR per RECIST v1.1, % (n/N)b | Target Lesion Response, % (n/N)a | ORR per RECIST v1.1, % (n/N)b |
| Melanoma (KEYNOTE-001) | 24.4 (43/176) | 8.6 (15/176) | 13.7 (43/313) | 4.8 (15/313) |
| NSCLC (KEYNOTE-001) | 11.6 (17/146) | 2.8 (4/146) | 5.7 (17/296) | 1.3 (4/296) |
| Gastric cancer (KEYNOTE-059) | 12.6 (11/87) | 1.1 (1/87) | 5.6 (11/198) | 0.5 (1/198) |
| HNSCC (KEYNOTE-048) | 8.9 (10/112) | 0.9 (1/112) | 4.9 (10/204) | 0.5 (1/204) |
| ccRCC (KEYNOTE-427) | 15.7 (8/51) | 9.8 (5/51) | 10.3 (8/78) | 6.4 (5/78) |
| UC (KEYNOTE-052) | 12.0 (15/125) | 7.2 (9/125) | 6.0 (15/252) | 3.6 (9/252) |
| UC (KEYNOTE-361) | 14.7 (15/102) | 2.9 (3/102) | 7.7 (15/194) | 1.6 (3/194) |
Abbreviations: ccRCC, clear-cell renal cell carcinoma; HNSCC, head and neck squamous cell carcinoma; NSCLC, non–small cell lung cancer; ORR, objective response rate; UC, urothelial carcinoma.
a
A ≥ 30% reduction in the sum of target lesion size from baseline was considered a clinically meaningful reduction.
b
ORR per RECIST v1.1 was calculated for each patient at each postprogression time point based on the sum of target lesion size (relative to the original time of PD), the appearance of new metastatic lesions, or progression of a nontarget lesion.