Table 4.
Investigator-assessed PFS and OS (safety-evaluable population)
| Population | CAVALLI phase 2 | GOYA IPI 2 to 5 | PFS HR (95% CI) adjusted* | OS HR (95% CI) adjusted* | ||||
|---|---|---|---|---|---|---|---|---|
| N | PFS (24 mo) | OS (24 mo) | N | PFS (24 mo) | OS (24 mo) | |||
| All | 206 | 79.6 | 85.6 | 564 | 67.2 | 80.9 | 0.61 (0.43-0.87) | 0.72 (0.48-1.10) |
| Bcl-2 IHC+ | 104 | 77.6 | 82.8 | 151 | 61.7 | 75.4 | 0.55 (0.34-0.89) | 0.67 (0.38-1.19) |
| Bcl-2 IHC− | 75 | 83.4 | 89.9 | 157 | 74.6 | 83.2 | 0.77 (0.39-1.50) | 0.90 (0.41-1.98) |
| DEL | 80 | 72.3 | 79.0 | 124 | 60.6 | 77.4 | 0.77 (0.46-1.29) | 0.95 (0.50-1.79) |
*
Covariates include age, sex, ECOG PS, body mass index, IPI (high vs nonhigh), bulky disease (>7.5 cm), disease stage (IV vs I-III), LDH, and COO subtype.