Eli Lilly and Company announced its Phase 3 RELAY study of CYRAMZA® (ramucirumab) met its primary endpoint of progression-free survival (PFS), 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 (NSCLC) whose tumors have activating EGFR mutations.
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. The most common (>5% incidence) Grade ≥3 adverse events occurring at a higher rate (≥5% difference) on the CYRAMZA-plus-erlotinib arm compared to the placebo-plus-erlotinib arm were hypertension, dermatitis acneiform (an acne-like rash), and diarrhea. Detailed efficacy and safety results will be submitted for presentation at a medical meeting in 2019.
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"Despite recent treatment advances in metastatic EGFR-mutated non-small cell lung cancer, prognosis remains poor and there is an ongoing need for additional first-line treatment options to help patients with this deadly disease," said Maura Dickler, M.D., vice president of late phase development, Lilly Oncology.
There is no cure for people with metastatic lung cancer. The disease is associated with low survival rates and disease progression following acquired resistance remains a challenge. Most patients receive several lines of treatment and the therapeutic regimen prescribed for first-line treatment can impact a person's options for later lines of treatment. Tyrosine kinase inhibitors (TKIs) are the current standard treatment option for EGFR-mutated NSCLC. Erlotinib, the TKI included in the RELAY trial regimen, is a globally recognized standard of care for this type of lung cancer.
"We are excited about these results, which show CYRAMZA plus erlotinib significantly delayed disease progression in this patient population. The RELAY trial is another example of Lilly's deep commitment to providing new treatment options to patients with lung cancer," said Dr. Dickler. "We would like to thank the patients, investigators and clinical trial sites that are participating in the RELAY study, and we look forward to working with regulatory authorities globally on our submissions."
Lilly intends to initiate global regulatory submissions in mid-2019.
RELAY is the second positive Phase 3 study of CYRAMZA in metastatic NSCLC. In the positive Phase 3 REVEL study, CYRAMZA plus docetaxel was compared to placebo plus docetaxel in people with metastatic NSCLC whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. The primary endpoint of overall survival was met, as well as key secondary endpoints of PFS and response rate. The REVEL results supported CYRAMZA's current indication in second-line NSCLC.
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.