US-based Eli Lilly and Company has reported results from REVEL, a global Phase III trial of Cyramza (ramucirumab) in combination with chemotherapy designed to treat patients with second-line non-small cell lung cancer (NSCLC).
The company said that REVEL is the first positive Phase III trial of a biologic in combination with chemotherapy to show improved overall survival compared to chemotherapy alone in second-line NSCLC.
In the US and most other countries, lung cancer is the leading cause of cancer death, while NSCLC accounts for 85% of all lung cancer cases.
It is estimated that about half of NSCLC patients are receiving treatment in the second-line setting.
Lilly Oncology product development and medical affairs senior vice-president Richard Gaynor said while there have been other recent Phase III trials that have evaluated the addition of a cytotoxic or targeted agent in previously-treated NSCLC patient populations, none have showed improved overall survival in the total patient population.
"We are pleased that Cyramza demonstrated a significant survival improvement in a difficult-to-treat patient population where there continues to be a major unmet medical need in both nonsquamous and squamous NSCLC patients," Gaynor said.
"This data builds on Lilly’s continued commitment to discovering potential new treatment options for the large numbers of people fighting lung cancer. They also add to our growing clinical data set for Cyramza, which is being studied in multiple tumour types."
The trial compared Cyramza plus docetaxel with placebo plus docetaxel in NSCLC patients with progression after platinum-based chemotherapy for locally advanced or metastatic disease.
A total of 1,253 nonsquamous and squamous NSCLC patients from 26 countries on six continents were part of the global, randomised, double-blind REVEL trial.
The trial’s primary endpoint was overall survival (OS), while secondary endpoints included progression-free survival (PFS) and objective response rate (ORR).
In the trial, patients treated on the Cyramza-plus-docetaxel arm achieved a median OS of 10.5 months compared with 9.1 months for patients on the placebo-plus-docetaxel arm.
The OS hazard ratio was 0.86, which corresponds to a 14% reduction in risk of death.
The company plans to submit the first application of these data to regulatory authorities in the second half of this year.