Phase III data on Cyramza for NSCLC published in The Lancet - Eli Lilly

Eli Lilly has announced detailed results from REVEL, a global Phase III study of Cyramza (ramucirumab) in combination with chemotherapy in patients with second-line Non-Small Cell Lung Cancer (NSCLC). Patients treated on the Cyramza-plus-docetaxel arm achieved a median OS of 10.5 months compared to 9.1 months for patients on the placebo-plus-docetaxel arm.

The OS hazard ratio was 0.86, which corresponds to a 14 percent reduction in risk of death. Median PFS was 4.5 months on the Cyramza-plus-docetaxel arm compared to 3.0 months on the placebo-plus-docetaxel arm, with a PFS hazard ratio of 0.76, which corresponds to a 24 percent reduction in risk of progression or death. ORR was 23 percent on the Cyramza-plus-docetaxel arm and 14 percent on the placebo-plus-docetaxel arm. The most common adverse events occurring more frequently in patients on the Cyramza arm were neutropenia, febrile neutropenia and fatigue.

REVEL is the first positive Phase III study of a biologic in combination with chemotherapy to demonstrate improved overall survival compared to chemotherapy alone in second-line NSCLC. Lilly intends to submit the first application of these data to regulatory authorities in the second half of 2014. Data from the trial were published in The Lancet and also presented at the American Society of Clinical Oncology (ASCO). See: "Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial." Edward B Garon et al. The Lancet, Early Online Publication, 2 June 2014, doi:10.1016/S0140-6736(14)60845-X