RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability

Ernest Nadal (), Hidehito Horinouchi, Jin-Yuan Shih, Kazuhiko Nakagawa, Martin Reck, Edward B. Garon, Yu-Feng Wei, Jens Kollmeier, Bente Frimodt-Moller, Emily Barrett, Olga Lipkovich, Carla Visseren-Grul and Silvia Novello
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Ernest Nadal: Catalan Institute of Oncology, IDIBELL, L’Hospitalet
Hidehito Horinouchi: National Cancer Center Hospital
Jin-Yuan Shih: National Taiwan University Hospital
Kazuhiko Nakagawa: Kindai University
Martin Reck: LungenClinic, Airway Research Center North, German Center for Lung Research
Edward B. Garon: David Geffen School of Medicine at UCLA/Translational Research in Oncology-US Network
Yu-Feng Wei: E-Da Cancer Hospital, I-Shou University
Jens Kollmeier: Helios Klinikum Emil von Behring
Bente Frimodt-Moller: Eli Lilly and Company
Emily Barrett: Eli Lilly and Company
Olga Lipkovich: Eli Lilly and Company
Carla Visseren-Grul: Lilly Oncology
Silvia Novello: University of Turin, A.O.U. San Luigi Gonzaga

Drug Safety, 2022, vol. 45, issue 1, No 5, 45-64

Abstract: Abstract Introduction RELAY was a global, double-blind, placebo-controlled phase III study that demonstrated superior progression-free survival (PFS) for ramucirumab plus erlotinib (RAM + ERL) versus placebo plus erlotinib (PBO + ERL) in the first-line treatment of patients with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) mutation-positive, metastatic non-small-cell lung cancer (NSCLC). Objective This article provides an in-depth analysis of the safety profile of RAM + ERL versus PBO + ERL observed in RELAY. Methods Eligible patients met these criteria: stage IV NSCLC; EGFR exon 19 deletion or exon 21 substitution (L858R) mutation; Eastern Cooperative Oncology Group performance status 0 or 1; and no central nervous system metastases. Patients were randomized (1:1) to receive erlotinib 150 mg/day orally plus either ramucirumab 10 mg/kg intravenously or matching placebo once every 2 weeks, until disease progression or unacceptable toxicity. The primary endpoint was PFS. Safety was evaluated based on reported treatment-emergent adverse events (AEs) and clinical laboratory assessments. Results The safety population comprised 446 patients (221 in RAM+ERL arm; 225 in PBO + ERL arm) who received at least one dose of study drug between January 2016 and February 2018. The overall incidence of grade ≥ 3 AEs was higher with RAM + ERL than with PBO + ERL, primarily driven by grade 3 hypertension. Grade ≥ 3 dermatitis acneiform and diarrhea were also reported more frequently in the RAM + ERL arm. The increased incidence of AEs with RAM + ERL was easily detected through routine monitoring and managed through dose adjustments and appropriate supportive care. Conclusion This in-depth safety analysis from RELAY supports that RAM + ERL, irrespective of the increased incidence of AEs, does not affect a patient’s ability to benefit from treatment. Clinical Trial Registration Number NCT02411448.

Date: 2022
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DOI: 10.1007/s40264-021-01127-2

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