Table 2.
Summary of Overall Best Responses, Investigator-Assessed Per RECIST Version 1.1 (ITT Population)
| Response Category | Daratumumab Plus Atezolizumab (n = 46), n (%, 95% CI) | Atezolizumab (n = 46), n (%, 95% CI) | OR (95% CI)a |
|---|---|---|---|
| CR | 0 (NE–NE) | 0 (NE–NE) | — |
| PR | 2 (4.3, 0.5–14.8) | 6 (13.0, 4.9–26.3) | — |
| SD | 22 (47.8, 32.9–63.1) | 14 (30.4, 17.7–45.8) | — |
| PD | 15 (32.6, 19.5–48.0) | 21 (45.7, 30.9–61.0) | — |
| NE | 7 (15.2, 6.3–28.9) | 5 (10.9, 3.6–23.6) | — |
| Overall response (CR+PR) | 2 (4.3, 0.5–14.8) | 6 (13.0, 4.9–26.3) | 0.30 (0.03–1.92) |
| CBR (CR+PR+SD) | 24 (52.2, 36.9–67.1) | 20 (43.5, 28.9–58.9) | 1.41 (0.58–3.36) |
CBR, clinical benefit rate; CI, confidence interval; CR, complete response; IC, immune cell; ITT, intent-to-treat; NE, not estimable; PD, progressive disease; PD-L1, programmed death-ligand 1; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; TC, tumor cell.
a
A Mantel-Haenszel estimate of the common OR stratified by PD-L1 expression status (IC0 and TC0 versus others), histology (squamous versus nonsquamous), and the number of previous lines of therapy received (one or greater than one).