Eli Lilly has reported positive results from the Phase III RELAY clinical trial performed to evaluate Cyramza (ramucirumab) in metastatic non-small cell lung cancer (NSCLC) patients with activating EGFR mutations.
RELAY met the primary endpoint with statistically significant improvement in progression-free survival (PFS). During the trial, Cyramza in combination with erlotinib was compared to placebo plus erlotinib as a first-line treatment.
Cyramza is an antiangiogenic therapy designed to specifically block the activation of vascular endothelial growth factor (VEGF) Receptor 2.
The global, randomised, double-blind, placebo-controlled RELAY trial assessed the drug combination in a total of 449 patients across North America, Europe, and Asia.
In addition to the primary endpoint of PFS, the trial also monitored key secondary endpoints such as safety, response rate, overall survival, and patient-reported outcomes.
The safety profile in the trial was found to be consistent with the previously available Phase III data of Cyramza and established profile of erlotinib.
The most common Grade ≥3 adverse events occurring at a higher rate in the drug combination arm were hypertension, dermatitis acneiform and diarrhea, compared to the placebo combination group.
Lilly Oncology late phase development vice-president Maura Dickler said: “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.
“We are excited about these results, which show Cyramza plus erlotinib significantly delayed disease progression in this patient population.”
The company is planning to initiate global regulatory submissions for the therapy over the coming months.
Lilly noted that RELAY is the second positive Phase III trial of Cyramza in metastatic NSCLC. The prior Phase III REVEL met its primary endpoint of overall survival, and key secondary endpoints of PFS and response rate.
REVEL compared Cyramza plus docetaxel with placebo plus docetaxel in metastatic NSCLC patients.