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2019 ASCO Annual Meeting!

Session: Lung Cancer—Non-Small Cell Metastatic

Type: Oral Abstract Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall B1

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).

Metastatic Non-Small Cell Lung Cancer

Lung Cancer—Non-Small Cell Metastatic

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr 9000)

Author(s): Kazuhiko Nakagawa, Edward B. Garon, Takashi Seto, Makoto Nishio, Santiago Ponce Aix, Chao-Hua Chiu, Keunchil Park, Silvia Novello, Ernest Nadal, Fumio Imamura, Kiyotaka Yoh, Jin-Yuan Shih, Kwok Hung Au, Denis Moro-Sibilot, Sotaro Enatsu, Annamaria H. Zimmermann, Bente Frimodt-Moller, Carla M. Visseren Grul, Martin Reck; Kindai University Hospital, Osaka, Japan; David Geffen School of Medicine, University of California/TRIO-US Network, Los Angeles, CA; National Kyushu Cancer Center, Fukuoka, Japan; Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan; Hospital 12 de Octubre, Madrid, Spain; Taipei Veterans General Hospital, Taipei, Taiwan; Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; Department of Oncology, University of Turin, Orbassano, Italy; Institut Català d’Oncologia, L’Hospitalet, Barcelona, Spain; Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan; National Cancer Center Hospital East, Kashiwa, Japan; Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Queen Elizabeth Hospital, Kowloon, China; Service Hospitalier Universitaire Pneumologie Physiologie Pôle Thorax et Vaisseaux Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France; Lilly Research Laboratories Japan, Kobe-shi, Japan; Eli Lilly & Co., Indianapolis, IN; Eli Lilly and Company, Copenhagen, Denmark; Lilly Oncology Europe, Utrecht, Netherlands; LungenClinic, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany

Abstract Disclosures


Background: Dual blockade of EGFR and VEGFR pathways in EGFRm NSCLC augments anti-tumor efficacy versus (v) EGFR inhibition alone. RELAY (NCT02411448) evaluated efficacy and safety of ERL, an EGFR TKI standard-of-care, plus RAM, a human IgG1 VEGFR2 antagonist, or PL in 1L EGFRm metastatic NSCLC. Methods: Eligibility included untreated metastatic NSCLC pts with Exon 19 deletion (del) or L858R and no CNS metastasis. Randomized (1:1) pts received ERL (150 mg/day) + RAM (10 mg/kg q2w) or ERL + PL, stratified by gender, geographic region (East Asia v other), EGFRm type (Ex19del v L858R) and EGFR testing method (Therascreen/Cobas v other). The primary endpoint was Investigator assessed progression free survival (PFS). Other objectives included ORR, DoR, PFS2, OS, safety, and plasma T790M mutation (Guardant NGS). Results: 449 pts were randomized characteristics were balanced between treatment arms: Asian 77%, Females 63%, Ex19del 54%. RAM + ERL significantly prolonged PFS, DoR, and PFS2 (Table). Grade >=3 TEAEs were greater with RAM (72%) v PL (54%), largely driven by hypertension (24 v 5%, no Gr4); with 1 treatment related on study death (hemothorax) in RAM v 0 PL. EGFR T790M+ rates at progression are forthcoming. Conclusion: RAM + ERL led to superior PFS in 1L EGFRm metastatic NSCLC. Safety was consistent with the established safety profiles of the individual compounds. Clinical trial information: NCT02411448

RAM + ERL (n=224)PL + ERL (n=225)HR (95% CI)p-value
PFS0.591 (0.461 – 0.760)<0.0001
Median, months (95% CI)19.4 (15.4 – 21.6)12.4 (11.0 – 13.5)
Censoring rate46%30%
ORR, % (95% CI)76.3 (70.8 – 81.9)74.7 (69.0 – 80.3)0.7413
Number of responders171168
DoR**0.619 (0.477 – 0.805)*0.0003*
Median, months (95% CI)18.0 (13.9 – 19.8)11.1 (9.7 – 12.3)
Censoring rate41%24%
PFS20.690 (0.490 – 0.972)0.0325
Median, months (95% CI)NRNR
Censoring rate73%65%
Interim OS0.832 (0.532 – 1.303)0.4209
Median, months (95% CI)NRNR
Censoring rate83%81%

Median follow-up: 20.7 months NR, not reached * unstratified **Ns are based on number of responders from the ITT population

Other Abstracts in this Sub-Category:


1. Association of STK11/LKB1 genomic alterations with lack of benefit from the addition of pembrolizumab to platinum doublet chemotherapy in non-squamous non-small cell lung cancer.

Meeting: 2019 ASCO Annual Meeting Abstract No: 102 First Author: Ferdinandos Skoulidis
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer


2. Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).

Meeting: 2019 ASCO Annual Meeting Abstract No: 110 First Author: Sean Khozin
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer


3. Phase III randomized trial comparing gefitinib to gefitinib with pemetrexed-carboplatin chemotherapy in patients with advanced untreated EGFR mutant non-small cell lung cancer (gef vs gef+C).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9001 First Author: Vanita Noronha
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer