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Eli Lilly: Phase 3 RELAY Study With CYRAMZA Meets Primary Endpoint - Quick Facts

Eli Lilly and Company (LLY) announced that its Phase 3 RELAY study of CYRAMZA (ramucirumab) met its primary endpoint of progression-free survival, demonstrating a statistically significant improvement in the time patients lived without their cancer growing or spreading after starting treatment. The Phase 3 global, randomized, double-blind trial is evaluating CYRAMZA in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in patients with metastatic non-small cell lung cancer whose tumors have activating EGFR mutations.

The company said the safety profile observed in the RELAY study was consistent with what has been previously observed for CYRAMZA in Phase 3 clinical trials and the established safety profile of erlotinib. Lilly intends to initiate global regulatory submissions in mid-2019.

The company noted that the results of previously completed Phase 3 studies of CYRAMZA have also supported approvals in second-line gastric and colorectal cancer. Based on the REACH-2 results, Lilly has made regulatory submissions in the U.S., EU and Japan for the use of CYRAMZA in second-line treatment of patients with hepatocellular carcinoma.

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