Phase III results positive for Cymraza + erlotinib in first line NSCLC/EGFR

Eli Lilly and Company announced that its Phase III RELAY study of Cymraza (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 III global, randomized, double-blind trial is evaluating Cymraza 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 Cymraza in Phase III clinical trials and the established safety profile of erlotinib. The most common ( greater than 5% incidence) Grade greater than 3, adverse events occurring at a higher rate on the Cymraza-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.

RELAY is the second positive Phase III study of Cymraza in metastatic NSCLC. In the positive Phase III REVEL study, Cymraza 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 Cymraza's current indication in second-line NSCLC.

Results of previously completed Phase III studies of Cymraza 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 Cymraza in second-line treatment of patients with hepatocellular carcinoma.

About the RELAY Trial : RELAY is a global randomized, double-blind, placebo-controlled Phase III study of Cymraza in combination with erlotinib, compared to placebo in combination with erlotinib, as a first-line treatment in previously untreated patients with metastatic NSCLC whose tumors have EGFR (epidermal growth factor receptor) exon 19 deletions or exon 21 (L858R) substitution mutations. Initiated in 2015, the study randomized 449 patients across North America, Europe and Asia. The primary endpoint of the RELAY trial is progression-free survival; key secondary endpoints include safety, response rate, overall survival, and patient-reported outcomes.