Eli Lilly's Cyramza Improves Survival In Phase 3 NSCLC Study

Eli Lilly & Co. announced positive results from the Phase III REVEL study in which Cyramza (ramucirumab) combined with chemotherapy in patients with second-line non-small cell lung cancer (NSCLC) improved overall survival.

Lung cancer remains the leading cause of cancer death in the U.S. and most other countries. Eighty-five percent of lung cancer cases are diagnosed as NSCLC, of which half receive treatment in the second-line setting.

Cyramza is a VEGF receptor 2 antagonist that inhibits activation of VEGF receptor 2 and binding ligands VEGF-A, VEGF-C, and VEGF-D. Ramucirumab as a single agent is currently approved for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma whose disease has progressed after chemotherapy.

The double blind, global, randomized, Phase III REVEL study investigated ramucirumab plus docetaxel against placebo with docetaxel in NSCLC patients whose disease progressed after undergoing platinum-based chemotherapy. Results showed that patients treated on the Cyramza arm reached a median overall survival of 10.5 months compared to 9.1 months of those on placebo. The trial is the first positive Phase III study of a biologic combined with chemotherapy that demonstrated overall survival compared to chemotherapy alone in second line NSCLC.

Richard Gaynor, SVP of product development and medical affairs for Lilly Oncology, said, “While there have been other recent Phase III studies that have evaluated the addition of a cytotoxic or targeted agent in previously-treated NSCLC patient populations, none have demonstrated improved overall survival in the total patient population.” Gaynor said that the company is pleased with REVEL’s positive data, which expands Cyramza’s growing clinical data set.

Maurice Perol from the Leon-Berard Cancer Centre in France and co-lead investigator of the REVEL study said, “In the REVEL study, Cyramza demonstrated statistically significant improvement across multiple efficacy endpoints including overall survival, progression-free survival and overall response rate. The improvement of overall survival and progression-free survival on the Cyramza-plus-docetaxel arm was also consistent across the majority of subgroups including histology.”

Trial results were published in The Lancet and presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.