Pneumologie 2021; 75(S 01): S42
DOI: 10.1055/s-0041-1723344
Latebreaking Abstracts 2021

RELAY, erlotinib plus ramucirumab or placebo in untreated EGFR-mutated metastatic NSCLC: outcomes by EGFR mutation type

Authors

  • K Nakagawa

    1   Department of Medical Oncology, Kindai University Faculty of Medicine

  • E Nadal

    2   Department of Medical Oncology, Catalan Institute of Oncology, Lʼhospitalet de Llobregat

  • E Garon

    3   David Geffen School of Medicine at University of California Los Angeles/Trio-US Network

  • M Nishio

    4   The Cancer Institute Hospital of Jfcr

  • T Seto

    5   National Kyushu Cancer Center

  • N Yamamoto

    6   Wakayama Medical University Hospital

  • K Park

    7   Department of Internal Medicine, National Taiwan University Hospital

  • J Y Shih

    7   Department of Internal Medicine, National Taiwan University Hospital

  • B Frimodt-Moller

    8   Eli Lilly and Company

  • A H Zimmerman

    8   Eli Lilly and Company

  • C Visseren-Grul

    9   Lilly Oncology

  • M Reck

    10   Lungenclinic, Airway Research Center North (Arcn), German Center for Lung Research (DZL)
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Background: In EGFR-mutated, metastatic (met) NSCLC, outcomes from EGFR tyrosine kinase inhibitors have differed historically by mutation (mut) type (lower benefit reported in patients (pts) with exon 21 L858R [ex21] versus exon 19 deletion [ex19]). In phase 3 RELAY, ramucirumab+erlotinib (RAM+ERL) provided superior progression-free survival (PFS) versus placebo+erlotinib (PBO+ERL). Additional efficacy and safety by mut type are reported here for the first time.

Methods: Pts with untreated met NSCLC, an EGFR ex19 or ex21 mut, and no CNS mets were randomized (1 : 1) to erlotinib (150 mg/day) with either ramucirumab (10 mg/kg)(RAM+ERL) or placebo (PBO+ERL), Q2W, until RECIST1.1 progression or unacceptable toxicity. Stratification factors included ex19/ex21 and East-Asian/Other. Primary endpoint: PFS. Secondary and exploratory endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DOR), safety, PFS2, biomarker analyses. Statistical analyses included Cox regression and Kaplan-Meier estimation. NCI-CTCAE 4.0 evaluated adverse events (AEs).

Results: More patients with ex21(83%) versus ex19(72%) were of Asian race. RAM+ERL demonstrated PFS benefit in ex19(0.651 [0.469 – 0.903], p = 0.01) and ex21(0.618 [0.437 – 0.874], p = 0.006). ORR showed consistent improvements across mut types for RAM+ERL (ex19:79%; ex21:74%) versus PBO+ERL (ex19: 83%; ex21: 66%). DCR for ex19 and ex21 was 96% and 95%, respectively, regardless of treatment arm. Safety profile (Grade ≥ 3, serious AEs, dose adjustments) was similar between mutation types. Exploratory data are forthcoming.

Conclusions: RAM+ERL-treated pts with ex21 mut had similar treatment benefit as pts with ex19 mut, which was consistent with that of the ITT. Safety profiles were as expected. Results support RAM+ERL as first-line therapy for both ex19/ex21-positive met NSCLC.


Publication History

Article published online:
30 April 2021

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