Table 1.
Cox proportional-hazards analysis of survival outcomes with depth-of-response variables in pooled patient cohorts
| Survival outcome | Pooled V cohort, n = 717 | Pooled C + V cohort, n = 310 |
|---|---|---|
| PFS | ||
| Event, n | 609 | 203 |
| K–M median, months (95% CI) | 6.9 (6.2–7.0) | 12.7 (10.6–14.7) |
| HR (95% CI)a | 1.0 (reference) | 0.80 (0.67–0.95) |
| p-valuea | 0.0103 | |
| Max%SLD before/at first PD | ||
| HR per 1% increase in Max%SLD (95% CI)b | 1.01 (1.01–1.01) | 1.02 (1.01–1.02) |
| p-valueb | <0.0001 | <0.0001 |
| TimeMax%SLD before/at first PD | ||
| HR per 1 month increase in TimeMax%SLD (95% CI)b | 0.86 (0.84–0.88) | 0.84 (0.81–0.87) |
| p-valueb | <0.0001 | <0.0001 |
| OS | ||
| Event, n | 495 | 148 |
| K–M median, months (95% CI) | 15.0 (13.8–16.8) | 28.0 (21.8–31.2) |
| HR (95% CI)a | 1.0 (reference) | 0.84 (0.68–1.03) |
| p-valuea | 0.0909 | |
| Max%SLD before/at first PD | ||
| HR per 1% increase in Max%SLD (95% CI)b | 1.01 (1.00–1.01) | 1.01 (1.00–1.01) |
| p-valueb | 0.0003 | 0.0071 |
| TimeMax%SLD before/on first PD | ||
| HR per 1 month increase in TimeMax%SLD (95% CI)b | 0.88 (0.85–0.91) | 0.85 (0.81, 0.89) |
| p-valueb | <0.0001 | <0.0001 |
C + V cobimetinib plus vemurafenib, CI confidence interval, HR hazard ratio, K–M Kaplan–Meier, Max%SLD maximum percentage change in the sum of longest diameters, OS overall survival, PD disease progression, PFS progression-free survival, SLD sum of longest diameters, TimeMax%SLD time to maximum percentage change in the sum of longest diameters, V vemurafenib monotherapy
aThe HR and p-values from the Cox proportional hazards regression model are for the comparison of two-pooled cohorts (pooled cobimetinib plus vemurafenib versus pooled vemurafenib)
bThe HR and p-values from the Cox proportional hazards regression model are for Max%SLD of target lesions before or on the first PD, or TimeMax%SLD of target lesion before or at the first PD within each cohort, analysed as continuous variables within each cohort