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Clinical Trial
. 2023 Jul;18(4):505-515.
doi: 10.1007/s11523-023-00975-5. Epub 2023 Jun 17.

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

Chao-Hua Chiu  1 , Meng-Chih Lin  2 , Yu-Feng Wei  3 , Gee-Chen Chang  4   5   6   7 , Wu-Chou Su  8 , Te-Chun Hsia  9 , Jian Su  10 , Anne Kuei-Fang Wang  11 , Min-Hua Jen  12 , Tarun Puri  13 , Jin-Yuan Shih  14
Affiliations
Clinical Trial

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

Chao-Hua Chiu et al. Target Oncol. 2023 Jul.

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: www.

Clinicaltrials: gov , NCT02411448.

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Conflict of interest statement

Chao-Hua Chiu has received consulting fees or honorarium from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly and Company, Janssen, Merck KGaA, Merck Sharp & Dohme, Novartis, Ono Pharmaceutical, Pfizer, Roche, Shionogi and Takeda. Gee-Chen Chang, Meng-Chih Lin, Jian Su, Wu-Chou Su and Yu-Feng Wei have no conflicts to declare. Te-Chun Hsia has received payment for lectures including service on speakers bureaus from AstraZeneca, Boehringer Ingelheim, Eli Lilly and Company, Roche, Takeda, Merck Sharp & Dohme, Merck KGaA, Bristol Myers Squibb and Amgen. Jin-Yuan Shih has received grants from Roche and Genconn Biotech; consulting fees or honorarium from ACT Genomics, Amgen, Genconn Biotech, AstraZeneca, Roche, Bayer, Boehringer Ingelheim, Eli Lilly and Company, Pfizer, Novartis, Merck Sharp & Dohme, Chugai Pharmaceutical, Takeda, CStone Pharmaceuticals, Janssen, TTY Biopharm, Orient EuroPharma, Mundipharma, Ono Pharmaceutical and Bristol Myers Squibb; and travel support from AstraZeneca, Roche, Boehringer Ingelheim and Chugai Pharmaceutical. Anne Kuei-Fang Wang, Min-Hua Jen and Tarun Puri are employees of Eli Lilly and Company with stock options.

Figures

Fig. 1
Fig. 1
Kaplan–Meier plot of PFS (investigator-assessed) for A Taiwanese subgroupa (n = 56) and B overall RELAY ITT population (n = 449)b. aMedian follow-up was 20.7 months (IQR 15·8–27.2). bFigure B reproduced [20] with permission from Elsevier. CI confidence interval, ERL erlotinib, HR hazard ratio, ITT intention to treat, PBO placebo, PFS progression-free survival, RAM ramucirumab
See this image and copyright information in PMC

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