Table 9.
Patients’ characteristics and outcomes of Checkmate 205 and KEYNOTE-087 trials of nivolumab and pembrolizumab, respectively, by arm/cohort.
| Patients’ Characteristics and Key Outcome and Toxicity Measures | CHECKMATE-205 (Nivolumab) [124,127,128] | KEYNOTE-087 (Pembrolizumab) [125,126] | ||||
|---|---|---|---|---|---|---|
| Arm A | Arm B | Arm C | Cohort 1 | Cohort 2 | Cohort 3 | |
| Description of Arm/Cohort | Failed autoSCT but no prior BV | Failed autoSCT and subsequent BV | Failed autoSCT but exposed to BV before and/or after autoSCT * | Failed autoSCT and subsequent BV | Ineligible for autoSCT; Failed salvage chemo and BV | Failed autoSCT but no subsequent BV given (may have failed prior BV) |
| Patients (number) | 63 | 80 | 100 | 69 | 81 | 60 |
| Median follow up | 33.0 months (all three arms combined) | 27.6 months (all three cohorts combined) | ||||
| Age (median; years) | 33 | 37 | 32 | 34 | 40 | 32 |
| PS 0 (%) | 62 | 53 | 50 | 42 | 54 | 48 |
| Previous Tx lines (median) | 2 | 4 | 4 | 4 | 4 | 3 |
| ≥3 previous lines of Tx (%) | 46 | 100 | 97 | 99 | 96 | 60 |
| Previous autoSCT (%) | 100 | 100 | 100 | 100 | 0 | 100 |
| Previous BV (%) | 0 | 100 | 100 | 100 | 100 | 42 |
| ORR per IRC | 65 | 71 | 75 | 77 | 67 | 73 |
| CR rate per IRC | 32 | 14 | 20 | 26 | 26 | 32 |
| Progression free survival (median; months) | 17 | 12 | 15 | 77 | 67 | 73 |
| Duration of response (median; months) | 25 ** | 16 ** | 18 ** | 22.1 † | 11.1 † | 24.4 † |
| Overall survival at two-years (%) | 90 | 86 | 86 | 92.5 | 90.6 | 89.4 |
* In arm C patients were to discontinue nivolumab after one year in persistent CR and treatment could be resumed if relapse occurred within two years from the last dose; ** Data presented at ASH 2018; not precisely reported in ref [128]; † For CRs versus PRs: Cohort 1 25 versus 19.5 months, cohort 2 19.2 versus 7.9 months, cohort 3 not reached versus 13.9 months.