US-based Eli Lilly and Company (NYSE: LLY) announced yesterday that its Phase 3 RELAY study of CYRAMZA(R) (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, randomised, 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 tumours 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 diarrhoea.

Detailed efficacy and safety results will be submitted for presentation at a medical meeting in 2019.

Maura Dickler, MD, vice president of late phase development, Lilly Oncology, 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.'