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Open Access 17-06-2023 | Erlotinib | Original Research Article

Efficacy and Tolerability of Ramucirumab Plus Erlotinib in Taiwanese Patients with Untreated, Epidermal Growth Factor Receptor-Mutated, Stage IV Non-small Cell Lung Cancer in the RELAY Study

Authors: Chao-Hua Chiu, Meng-Chih Lin, Yu-Feng Wei, Gee-Chen Chang, Wu-Chou Su, Te-Chun Hsia, Jian Su, Anne Kuei-Fang Wang, Min-Hua Jen, Tarun Puri, Jin-Yuan Shih

Published in: Targeted Oncology | Issue 4/2023

Abstract

Background

In RELAY, a randomized, double-blind, phase III trial investigating the efficacy and safety of ramucirumab+erlotinib (RAM+ERL) or ERL+placebo (PBO) in patients with untreated, stage IV, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), RAM+ERL demonstrated superior progression-free survival (PFS) versus PBO+ERL, with no new safety signals.

Objective

The aim of this paper was to report efficacy and tolerability findings for the Taiwanese participants of RELAY.

Patients and Methods

Patients were randomized 1:1 to RAM+ERL or ERL+PBO. Primary endpoint was investigator-assessed PFS. Secondary endpoints included objective response rate (ORR), duration of response (DoR) and tolerability. Data for the current analysis are reported descriptively.

Results

In RELAY, 56 Taiwanese patients were enrolled; 26 received RAM+ERL, 30 received ERL+PBO. The demographic profile of the Taiwanese subgroup was consistent with that of the overall RELAY population. Median PFS for RAM+ERL/ERL+PBO, respectively, was 22.05 months/13.40 months (unstratified hazard ratio 0.4; 95% confidence interval 0.2–0.9); ORR was 92%/60%; median DoR was 18.2 months/12.7 months. All patients experienced one or more treatment-emergent adverse events (TEAEs); those most commonly reported were diarrhea and dermatitis acneiform (58% each) for RAM+ERL and diarrhea (70%) and paronychia (63%) for PBO+ERL. Grade ≥ 3 TEAEs were experienced by 62%/30% of RAM+ERL/PBO+ERL patients, respectively, and included dermatitis acneiform (19%/7%), hypertension (12%/7%), and pneumonia (12%/0%).

Conclusions

PFS for the Taiwanese participants of RELAY receiving RAM+ERL versus ERL+PBO was consistent with that in the overall RELAY population. These results, together with no new safety signals and a manageable safety profile, may support first-line use of RAM+ERL in Taiwanese patients with untreated EGFR-mutant stage IV NSCLC.

Trial Registration

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Title: Efficacy and Tolerability of Ramucirumab Plus Erlotinib in Taiwanese Patients with Untreated, Epidermal Growth Factor Receptor-Mutated, Stage IV Non-small Cell Lung Cancer in the RELAY Study
Authors: Chao-Hua Chiu
Meng-Chih Lin
Yu-Feng Wei
Gee-Chen Chang
Wu-Chou Su
Te-Chun Hsia
Jian Su
Anne Kuei-Fang Wang
Min-Hua Jen
Tarun Puri
Jin-Yuan Shih
Publication date: 17-06-2023
Publisher: Springer International Publishing
Keywords: Erlotinib
Ramucirumab
NSCLC
NSCLC
Published in: Targeted Oncology / Issue 4/2023
Print ISSN: 1776-2596
Electronic ISSN: 1776-260X
DOI: https://doi.org/10.1007/s11523-023-00975-5

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Background

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Patients and Methods

Results

Conclusions

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