In a Phase 3 trial, Eli Lilly's (LLY -0.6%) Cyramza (ramucirumab) in combination with chemotherapy extended overall survival (OS) in patients with second-line non-small cell lung cancer (NSCLC). The study compared Cyramza plus docetaxel to placebo plus docetaxel in NSCLC patients with progression after platinum-based chemotherapy for locally-advanced or metastatic disease. The primary endpoint was OS while the secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).
Patients in the Cyramza plus docetaxel arm (n=628) achieved a median OS of 10.5 months compared to 9.1 months for patients in the placebo plus docetaxel arm with a OS hazard ratio of 0.86, meaning there was a 14% reduction in risk of death.
Median PFS was 4.5 months in the Cyramza cohort and 3.0 months in the placebo group with a PFS hazard ratio of 0.76, meaning there was a 24% reduction in the risk of progression or death.
ORR was 23% in the Cyramza cohort and 14% in the placebo group.
The company plans to submit its application to regulatory authorities in 2H 2014.