Table 4.
Best overall tumor response and time to progression
| Phase Ib | Phase II | ||||||||
| 1100 mg AMG 820 + 200 mg pembrolizumab | 1400 mg AMG 820 + 200 mg pembrolizumab | Total | pMMR CRC | Pancreatic cancer | NSCLC | Total | |||
| PD-1-naïve with PDL-1 <50% | PD-1 failure with PDL-1 <50% | PD-1 failure with PDL-1 ≥50% | |||||||
| Group 1 | Group 2 | Group 3 | Group 4 | Group 5 | |||||
| n=8 | n=7 | n=15 | n=41 | n=31 | n=4 | n=19 | n=6 | n=101 | |
| Responses, n (%) | |||||||||
| irPR | – | – | – | 2 (5) | – | – | 1 (5) | – | 3 (3) |
| irSD | 2 (25) | 2 (29) | 4 (27) | 13 (32) | 8 (26) | 2 (50) | 9 (47) | 3 (50) | 35 (35) |
| irPD | 3 (38) | 5 (71) | 8 (53) | 21 (51) | 12 (39) | 1 (25) | 4 (21) | 2 (33) | 40 (40) |
| Not available* | 3 (38) | – | 3 (20) | 4 (10) | 11 (36) | 1 (25) | 4 (21) | 1 (17) | 21 (21) |
| Unable to evaluate | – | – | – | 1 (2) | – | – | 1 (5) | – | 2 (2) |
| KM time to progression | |||||||||
| n | – | – | 10 | 29 | 13 | 3 | 8 | 4 | 57 |
| Median (range), months | – | – | 1.7 (0.5–5.6) | 2.0 (0.6–8.4) | 2.1 (0.3–4.7) | 5.4 (2.1–6.6) | 5.1 (1.2–12.0) | 7.8 (1.9–13.7) | 2.1 (0.3–13.7) |
Best overall tumor response (as reported by the investigators) and time to tumor progression were determined according to irRECIST.
*Three patients in the phase Ib part and 21 in the phase II part with scans ‘not available’ came off treatment before the initial planned scan. Most of these patients came off treatment due to disease progression.
irPD, immune-related progressive disease; irPR, immune-related partial response; irRECIST, immune-related Response Evaluation Criteria in Solid Tumours; irSD, immune-related stable disease; KM, Kaplan-Meier; NSCLC, non-small cell lung cancer; PD-1, programmed cell death-1; PD-L1, programmed cell death-ligand 1; pMMR CRC, mismatch repair-proficient colorectal cancer.