Dr Le on the Efficacy of Osimertinib Plus Ramucirumab in EGFR-Mutant mNSCLC

Xiuning Le, MD, PhD, assistant professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center, discusses findings from the interim analysis of the phase 2 RAMOSE trial (NCT03909334) in patients with TKI-naïve metastatic non–small cell lung cancer (mNSCLC) harboring EGFR mutations.

RAMOSE enrolled patients with advanced NSCLC and classical EGFR mutations who had not received prior TKIs or VEGF-directed therapy. Patients needed to have an ECOG performance status of 0 or 1, stable central nervous system metastases, if present, and no recent pulmonary embolism or stroke. Patients were randomly assigned 2:1 to receive either osimertinib (Tagrisso) plus ramucirumab (Cyramza) or osimertinib monotherapy. The primary end point of this trial was investigator-assessed progression-free survival (PFS) per RECIST v1.1. Key secondary end points include overall response rate, disease control rate, overall survival, and safety.

A total of 139 patients in the United States were treated in this study, 93 in the combination arm and 46 in the monotherapy arm. All patients included in the interim analysis had received at least 1 efficacy scan, Le says. In the combination arm, 64.5% of patients were White, 25.8% of patients were Asian, 3.2% of patients were Black, and 6.5% of patients were other races. These percentages in the monotherapy arm were 56.5%, 21.7%, 4.3%, and 17.4%, respectively.

At a median follow-up of 16.6 months, the median PFS by investigator assessment was 24.8 months (95% CI, 17.9-not reached) with the combination vs 15.6 months (95% CI, 11.7-22.8) with osimertinib monotherapy (HR, 0.55; 95% CI, 0.32-0.93; log-rank P = .026). The median duration of ramucirumab treatment in the combination arm was 14.2 months, and patients received ramucirumab at 86.6% dose intensity. 

These findings show that the combination of osimertinib and ramucirumab prolongs PFS and provides patients with additional survival benefits vs osimertinib monotherapy, Le concludes.

Editor’s Note: Dr Le reports consulting or advisory fees from Eli Lilly, EMD Serono (Merck, KGaA), AstraZeneca, Spectrum Pharmaceuticals, Novartis, Regeneron, Boehringer Ingelheim, Hengrui Therapeutics, Bayer, Teligene, Taiho, Daiichi Sankyo, Janssen, Blueprint Medicines, Sensei Biotherapeutics, SystImmune, ArriVent, Abion, and AbbVie; institutional research funding from Eli Lilly, EMD Serono, Arrivent, Dizal, Teligene, Regeneron, Janssen, ThermoFisher, Takeda, and Boehringer Ingelheim; travel support from EMD Serono, Janssen, and Spectrum Pharmaceuticals; and stock options from BlossomHill.