Pneumologie 2025; 79(S 01): S53-S54
DOI: 10.1055/s-0045-1804653
Abstracts
B1 – Pneumologische Onkologie

RELAY: Final Overall Survival with Erlotinib+Ramucirumab or Placebo in Untreated, EGFR-Mutated Metastatic NSCLC (mNSCLC)

Authors

  • K Nakagawa

    1   Department of Medical Oncology, Kindai University Faculty of Medicine

  • E Garon

    2   David Geffen School of Medicine at Ucla/Trio-US Network

  • M Nishio

    3   The Cancer Institute Hospital, Japanese Foundation for Cancer Research; The Cancer Institute Hospital, Tokyo, Japan

  • T Seto

    4   National Hospital Organization Kyushu Cancer Center; Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center

  • K Nishio

    5   Department of Genome Biology, Kindai University Faculty of Medicine

  • K Kasahara

    6   Department of Pulmonary Medicine and Oncology, Nippon Medical School Hospital

  • K Nishino

    7   Department of Thoracic Oncology, Osaka International Cancer Institute

  • M Satouchi

    8   Department of Thoracic Oncology, Hyogo Cancer Center

  • K Yoh

    9   National Cancer Center Hospital East

  • H Hayashi

    10   Kindai University Faculty of Medicine; Department of Medical Oncology

  • S Enatsu

    11   Japan Drug Development & Medical Affairs, Eli Lilly Japan K.K

  • B Frimodt-Moller

    12   Eli Lilly Denmark A/S

  • T Matsui

    11   Japan Drug Development & Medical Affairs, Eli Lilly Japan K.K

  • S Chacko Varughese

    13   Statistics, Eli Lilly Services India Pvt. Ltd

  • C Visseren-Grul

    14   Eli Lilly and Company

  • M Reck

    15   Lungenclinic Großhansdorf Gmbh; Onkologischer Schwerpunkt

  • S Hammerschmidt

    16   Klinikum Chemitz; Klinik für Innere Medizin Iv
Further Information
Also available at
 
 

RELAY (NCT02411448) was a Phase 3 global double-blind, placebo-controlled study. Erlotinib (ERL)+ramucirumab (RAM) demonstrated statistically significant improvement in the primary endpoint of progression-free survival (PFS) (HR 0.59 [95% CI 0.461–0.760, p<0.0001, mPFS 19.4 vs 12.4 mo]) in patients (pts) with untreated EGFR-mutated mNSCLC. We report final overall survival (OS) outcomes for the intention-to-treat (ITT) population.

Sites randomized 449 eligible pts between Jan 2016 and Feb 2018 with an EGFR exon 19del or L858R mutation and no CNS metastases (1:1) to ERL (150 mg/day) with RAM (10 mg/kg q2w, n=224) or placebo (PBO, n=225). OS, a secondary endpoint, was to be analyzed at ~300 deaths. RELAY was not powered for OS.

Two hundred and ninety-seven deaths were reported at data cut-off (66% maturity). ERL+RAM showed numerically greater improvement in mOS vs ERL+PBO, at a median follow-up of 45.1 mo (IQR 26.70–71.20), in the ITT population (51.1 vs 46.0 mo: HR 0.98 [95% CI 0.78–1.24]). . ERL+RAM showed numeric improvement for OS in pts with a L858R vs Exon 19del mutation: ITT: L858R (n=204), mOS 51.6 vs 45.8 mo, HR 0.87 (95% CI 0.62–1.22). Exon 19del (n=243): mOS 49.0 vs 51.4 mo, HR 1.13 (95% CI 0.83–1.55).

The reported safety profile for ERL+RAM in this analysis was consistent with previous reports, with no increased toxicity noted over time.

Both ERL=RAM and ERL+PBO treatment arms reported long OS durations. The ERL+RAM arm demonstrated numerical improvement in mOS in the ITT population compared with the ERL+PBO arm. Data indicate that pts with L858R mutation derive more modest OS with EGFR-TKI monotherapy than the pts with Exon 19del, and might benefit from treatment intensification with ramucirumab.

DISCLOSURE

Originally presented at JSMO 2024


Publication History

Article published online:
18 March 2025

© 2025. Thieme. All rights reserved.

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany