Treatment with ramucirumab (Cyramza) in combination with erlotinib significantly delayed disease progression in previously untreated patients with metastatic non-small cell lung cancer (NSCLC), according to new data from a phase 3 clinical trial.
Eli Lilly reported the findings from the phase 3 RELAY study evaluating the combination as a first-line therapy in patients with metastatic disease whose tumors have activating epidermal growth factor receptor (EGFR) mutations.
Currently, metastatic EGFR-mutated NSCLC is associated with poor survival rates and disease progression following acquired resistance from therapies. Tyrosine kinase inhibitors, such as erlotinib, are the current standard-of-care in this patient population.
“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,” Maura Dickler, MD, vice president of late phase development at Lilly Oncology, said in a statement.
The RELAY trial, which was initiated in 2015, randomized 449 patients with a primary endpoint of progression-free survival and key secondary endpoints including safety, response rate, overall survival (OS), and patient-reported outcomes. The combination treatment’s safety profile was consistent with previous phase 3 clinical trials evaluating ramucirumab and erlotinib.
This trial was the second positive phase 3 study of ramucirumab in metastatic NSCLC. In the phase 3 REVEL study, ramucirumab plus docetaxel was compared with placebo plus docetaxel in patients with metastatic NSCLC whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. The primary endpoint of OS for this study was met.
Additionally, previously completed phase 3 studies supported approvals for ramucirumab in second-line gastric and colorectal cancer.
Ramucirumab is currently approved in the United States for use:
  • As a single agent or in combination with paclitaxel as a treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose cancer has progressed on or after fluoropyrimidine.
  • In combination with docetaxel as a treatment for patients with metastatic NSCLC whose cancer has progressed on or after platinum-based chemotherapy.
  • In combination with FOLFIRI as a treatment for patients with metastatic colorectal cancer whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
 Detailed safety and efficacy data from the phase 3 RELAY trial will be presented at a medical meeting in 2019, according to Lilly.
Lilly’s Cyramza (ramucirumab) phase 3 RELAY trial met primary endpoint, significantly improving progression-free survival in first-line treatment of patients with metastatic EGFR-mutated non-small cell lung cancer [news release]. Eli Lilly. Accessed March 12, 2019.