Table 2 –
ClarIDHyTrial: Efficacy results
| Ivosidenib (n= 124) | Placebo (n= 61) | |
|---|---|---|
| Progression-Free Survival by Independent Review Committee | ||
| Events, n (%) | 76 (61) | 50 (82) |
| Progressive disease, n (%) | 64 (52) | 44 (72) |
| Deaths, n (%) | 12 (10) | 6 (10) |
| Hazard ratio (95% CI)1 | 0.37 (0.25, 0.54) | |
| p-value2 | <0.0001 | |
| Objective Response Rate, n (%) | 3 (2%) | 0 |
| Overall Survival 3 | N= 126 | N=61 |
| Deaths, n (%) | 100 (79) | 50 (82) |
| Hazard ratio (95% CI)1 | 0.79 (0.56, 1.12) | |
| p-value2 | 0.093 | |
CI: confidence interval
1
Hazard ratio is calculated from stratified Cox regression model. Stratified by number of prior lines of therapy.
2
P-value is calculated from the one-sided stratified log-rank test. Stratified by number of prior lines of therapy.
3
OS results are based on the final analysis of OS (based on 150 deaths) which occurred 16 months after the final analysis of PFS without adjusting for crossover. In the analysis of OS, 70% of the patients randomized to placebo had crossed over to receive ivosidenib after radiographic disease progression.
Data from TIBSOVO Prescribing Information (15)