Table 11.
Response rate and duration of response [modified from 47]
| IRF RECIST v1.1 | IRF HCC mRECIST | |||
|---|---|---|---|---|
| Atezo + Beva (n = 326) | sorafenib (n = 159) | Atezo + Beva (n = 325)a | sorafenib (n = 158) | |
| Confirmed ORR, n (%) (95% CI) | 89 (27) (23–33) | 19 (12) (7–18) | 108 (33) (28–39) | 21 (13) (8–20) |
| CR | 18 (6) | 0 | 33 (10) | 3 (2) |
| PR | 71 (22) | 19 (12) | 75 (23) | 18 (11) |
| Stratified p valueb | <0.0001 | <0.0001 | ||
| SD, n (%) | 151 (46) | 69 (43) | 127 (39) | 66 (42) |
| PD, n (%) | 64 (20) | 39 (25) | 66 (20) | 40 (25) |
| DCR, n (%) | 240 (74) | 88 (55) | 235 (72) | 87 (55) |
| Ongoing response, n (%)c | 77 (87) | 13 (68) | 84 (78) | 13 (62) |
| Median DOR, months | NE | 6.3 (4.7 to NE) | NE | 6.3 (4.9 to NE) |
| Event-free rate at 6 months, n (%) | 88 | 59 | 82 | 63 |
IRF, independent review facility; HCC, hepatocellular carcinoma; Atezo, atezolizumab; Beva, bevacizumab; ORR, objective response rate; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; DCR, disease control rate; DOR, duration of response; NE, not estimable.
IRF HCC mRECIST-evaluable population was based on patients who presented with measurable disease at baseline per HCC mRECIST criteria.
Stratification factors included geographic region (Asia vs. rest of the world, including Japan), AFP level (<400 vs. ≥400 ng/mL) at baseline, and MVI and/or EHS (yes vs. no) per IxRS.
Denominator is patients with confirmed CR/PR. Data cutoff, 29 August 2019; median survival follow-up, 8.6 months.