|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
One year after publishing phase Ib results of the RELAY trial, investigators presented phase 3 findings at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2
RELAY is a multicenter, double-blind, randomized clinical trial that enrolledin patients who had no prior treatment for 1L epidermal growth factor receptor (EGFR)-mutant metastatic non−small cell lung cancer.2
The objective was to assess progression-free survival (PFS) in patients receiving therapy that inhibits either the EGFR pathway alone (erlotinib + placebo), or both the EGFR and the vascular endothelial growth factor receptor (VEGFR) pathways (erlotinib + ramucirumab). Secondary end points included overall response rate (ORR), duration of response (DoR), and safety. Exploratory end points were PFS2 and the identification of biomarkers.2
A total of 449 patients (77% Asian, 63% female, 55% had an exon 19 deletion [vs exon 21 L858R substitution mutation]) were randomly selected in a 1:1 ratio to receive 1 of the 2 treatment arms. Dosing was ERL (150 mg/day) + RAM (10 mg/kg q2w) or ERL (150 mg/day) + placebo (PBO).2
The dual blockade of the EGFR and VEGFR pathways with ERL + RAM significantly improved PFS compared with ERL + PBO (19.4 [95% CI, 15.4-21.6] vs 12.4 [95% CI, 11.0-13.5], respectively). In addition, DoR and PFS2 were significantly improved with ERL + RAM compared with ERL + PBO (DoR: 18.0 [95% CI, 13.9-19.8] vs 11.1 [95% CI, 9.7-12.3], respectively; PFS2: hazard ratio [HR] 0.690; 95% CI, 0.490-0.972). There was no significant difference in ORR.2
Patients taking ERL + RAM experienced more grade 3 or higher adverse effects compared with ERL + placebo (72% vs 54%), most of which was influenced by hypertension (24% vs 5%, no grade 4). One treatment-related death was reported with ERL + RAM.2
The authors concluded, “RAM + ERL led to superior PFS in 1L EGFRm metastatic NSCLC. Safety was consistent with the established safety profiles of the individual compounds.”2
Read more of Cancer Therapy Advisor‘s coverage of ASCO’s annual meeting by visiting the conference page.
- Reck M, Garon EB, Paz-Ares L, et al. Randomized, double-blind phase Ib/III study of erlotinib with ramucirumab or placebo in previously untreated EGFR-mutant metastatic non-small-cell lung cancer (RELAY): phase Ib results. Clin Lung Cancer. 2018;19(3):213-220.
- Nakagawa K, Garon EB, Seto T, et al. RELAY: A multinational, double-blind, randomized Phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor mutation-positive (EGFRm) metastatic non-small cell lung cancer (NSCLC). Presented at: 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 9000.