(Lung Cancer) Is Ramucirumab (Cyramza) Plus Erlotinib Effective? RELAY Phase 3 Trial Results

• December 16, 2019
• 2 min read

Updated: January 27, 2020

On October 4, 2019, Kazuhiko Nakagawa published results in The Lancet Oncology from the RELAY Phase 3 clinical trial evaluating the efficacy and safety of ramucirumab (Cyramza, anti-VEGFR antibody) plus erlotinib (EGFR tyrosine kinase inhibitor) in treatment-naive EGFR-positive non-small cell lung cancer (NSCLC) patients.

Trial Design:

The RELAY Phase 3 trial was an international multicenter, double-blind study. Treatment-naive EGFR-positive NSCLC patients (N=449) were randomized to:

• Ramucirumab group (N=224): Ramucirumab 10 mg/kg every 2 weeks + erlotinib 150 mg once daily
• Placebo group (N=225): Placebo every 2 weeks + erlotinib 150 mg once daily

Primary endpoints were PFS and safety; secondary endpoints were OS and ORR.

Background: VEGF and EGFR inhibitors had individually demonstrated efficacy in EGFR-positive NSCLC patients in both preclinical and clinical settings. The RELAY trial was designed to evaluate whether combining a VEGFR antibody with an EGFR TKI would improve outcomes.

Results at median follow-up of 20.7 months:

• Median PFS: Ramucirumab 19.4 months vs. placebo 12.4 months
• 41% reduction in progression risk — statistically significant improvement

Safety:

Grade 3–4 adverse events: Ramucirumab 72% (N=159) vs. placebo 54% (N=121). Most common Grade 3–4 adverse events: Ramucirumab arm — hypertension 24% (N=52), dermatitis 15% (N=30); Placebo arm — dermatitis 9% (N=20), ALT elevation 8% (N=17).

Serious adverse events: Ramucirumab 29% (N=65) vs. placebo 21% (N=47). Most common serious events: Ramucirumab arm — pneumonia 3% (N=7), cellulitis (N=4), pneumothorax (N=4); Placebo arm — fever 1% (N=3), pneumonia 1% (N=3).

Conclusion: Based on the RELAY trial results, Kazuhiko Nakagawa concluded that ramucirumab plus erlotinib significantly improved PFS in treatment-naive EGFR-positive NSCLC patients, with acceptable tolerability.

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Source: Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Oct 4. doi:10.1016/S1470-2045(19)30634-5.

Lung Cancer | Ramucirumab | Cyramza | Erlotinib | RELAY

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