ChemoID assay-guided therapy increased OS and progression-free survival (PFS) of patients with rGBM
death, physician-choice
EVENTS
A statistically significant difference was observed in the risk of death between groups (hazard ratio [HR] = 0.44; 95% confidence interval [CI], 0.24–0.81; p = 0.008) in the interim efficacy analysis. In the ChemoID assay-guided group, 67% of patients (18 of 27) died vs. 87% (20 of 23) in the physician-choice group. Furthermore, median overall survival (mOS) was 12.5 months (95% CI, 10.2–14.7) with ChemoID assay-guided therapy vs. 9 (95% CI, 4.2–13.8) with physician choice (log rank p = 0.010) (OS and PFS are significantly improved by ChemoID-guided therapy(A) Prespecified interim efficacy analysis of OS. The number of events; median OS; OS rates at 0, 6, 12, and 18 months; and the Kaplan-Meier curve for OS in all patients treated with ChemoID-guided (blue) vs. physician-choice (red) therapies. Symbols, censored observations.(B) Prespecified interim efficacy analysis of PFS. The number of events; median PFS; PFS rates at 0, 6, 12, and 18 months; and the Kaplan-Meier curve for PFS per investigator assessment in patients treated with ChemoID-guided (blue) vs. physician-choice (red) therapies. Symbols indicate censored observations.(C) Intention-to-treat analysis of OS. The number of events; median OS; OS rates at 0, 6, 12, and 18 months; and the Kaplan-Meier curve for OS in all patients treated with ChemoID-guided (blue) vs. physician-choice (red) therapies. Symbols, censored observations.(D) Intention-to-treat Analysis of PFS. The number of events; median PFS; PFS rates at 0, 6, 12, and 18 months; and the Kaplan-Meier curve for PFS per investigator assessment in patients treated with ChemoID-guided (blue) vs. physician-choice (red) therapies. Symbols indicate censored observations. A Cox proportional hazards model estimated hazard ratios (HRs) and CIs.Secondary endpoints: Interim efficacy analysis of OS and PFS probabilityNC, not calculable.The median progression-free survival (mPFS) was 10.1 months (95% CI, 4.8–15.4) for patients receiving ChemoID assay-guided therapy vs. 3.5 months (95% CI, 1.9–5.1) for physician-choice therapy (HR, 0.25; 95% CI, 0.14–0.44; p < 0.001) (ChemoID assay-guided therapy continued to demonstrate meaningful clinical benefit in mOS throughout follow-up. In ITT analysis, a statistically significant difference was also observed in the risk of death between groups (HR = 0.52; 95% CI, 0.24–0.81; p = 0.008). In the ChemoID assay-guided group, 70% of patients (30 of 43) died vs. 91% (32 of 35) in the physician-choice group. Furthermore, mOS was 12 months (95% CI, 10.8–13.2) with ChemoID assay-guided therapy vs. 7.5 (95% CI, 3.5–11.5) with physician choice (log rank p = 0.009) (Secondary endpoints: ITT analysis of OS and PFS probabilityThe mPFS was 6.5 months (95% CI, 3.3–9.7) for patients receiving ChemoID assay-guided therapy vs. 3.3 months (95% CI, 2.1–4.5) for physician-choice therapy (HR, 0.36; 95% CI, 0.23–0.57; p < 0.001) (