For patients with unresectable Stage III NSCLC who have received cCRT1-3
IMFINZI transforms 5-year survival expectations
1
5-YEAR POST-HOC OS ANALYSIS3†
50%
37% 18% OS rate: PFS rate:
36%
Primary analysis in the ITT population1
vs vs
with placebo with placebo
Median OS†: Not reached vs 28.7 months with placebo (HR=0.68; P=0.0025)
Median PFS‡: 16.8 vs 5.6 months with placebo (HR=0.52; P<0.0001)
Therapeutic Indications
IMFINZI is indicated for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.²
NSCLC=non-small cell lung cancer; CRT=chemoradiation therapy; PD-L1=programmed death-ligand 1; OS=overall survival; PFS=progression-free survival; ITT=intentto-treat; HR=hazard ratio; CI=confidence interval; NR=not reached; RECIST=Response Evaluation Criteria in Solid Tumors; BICR=blinded independent central review.
* The post hoc 5-year OS analysis was conducted at ~5 years after last patient was randomized and was not powered to show statistical significance. Median OS was 47.5
months with IMFINZI (95% CI, 38.1-52.9) vs 29.1 months with placebo (95% CI, 22.1-35.1) Reduction in the risk of death vs placebo was 28% (HR=0.72; 95% CI, 0.59-0.89). OS rates with IMFINZI vs placebo were 83% (95% CI 79.4-86.2) vs 75% (95% CI, 68.5-79.7) at 12 months 66% (95% CI 61.8-70.4) vs 55% (95% CI 48.6-61.4) at 24 months, 57% (95% CI, 52.0-61.1) vs 44% (95% CI, 37.1-49.9) at 36 months, 50% (95% CI, 45.0-54.2) vs 36% (95% CI, 30.1-42.6) at 48 months, and 43% (95% CI, 38.2-47.4) vs 33% (95% CI, 27.3-39.6) at 60 months.1
†The primary 2-year OS analysis was conducted after 299 deaths for 42% maturity (61% of targeted events) with a median follow-up of 25.2 months. Reduction in the risk of death vs placebo was 32% (HR=0.68; 95% CI, 0.53-0.87). Median OS was NR with IMFINZI (95% CI, 34.7-NR) vs 28.7 months with placebo (95% CI, 22.9-NR) 1
‡Measured based on RECIST v1.1 criteria by BICR The primary PFS analysis was conducted after 371 events (81% of targeted 458 events) with a median follow-up of 14.5 months. Reduction in the risk of progression or death vs placebo was 48% (HR=0.52; 95% CI, 0.42-0.65). Median PFS was 16.8 months with IMFINZI (95% CI, 13.0-18.1) vs 5.6 months with placebo (95% CI, 4.6-7.8).2
1. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).Non-small cell lung cancer. Version 7. 2021. Available at: https://www.nccn.org/guidelines/ Accessed November 2021.
2. IMFINZI® (Durvalumab). Summary of Product Characteristics.
3. Stewart R et al. Cancer Immunol Res 2015;3(9):1052-62.