Found 1 Presentation For Request "1298P"
1298P - RELAY, ramucirumab plus erlotinib (RAM+ERL) versus placebo plus erlotinib (P+ERL) in untreated EGFR mutated metastatic non-small cell lung cancer (NSCLC): Exposure-response relationship
- Kazuhiko Nakagawa (Osaka, Japan)
Abstract
Background
In RELAY, a dose of RAM 10 mg/kg every 2 weeks (Q2W) was selected based on exposure-response analysis, using data from second-line (2L) phase 3 studies investigating RAM 8 mg/kg Q2W in gastric and hepatic cancer and 10 mg/kg Q3W in NSCLC. Data from these studies showed that patients with the higher RAM exposure (
Methods
Patients received RAM (10 mg/kg, N=216) or P (N=225) Q2W plus ERL (150 mg/day). A population pharmacokinetic model predicted RAM minimum concentration after first dose (
Results
As expected, RAM 10 mg/kg Q2W delivered
Conclusions
The recommended 10 mg/kg Q2W RAM dose combined with ERL (150 mg/day) is an efficacious and safe 1L treatment for
Clinical trial identification
NCT02411448.
Editorial acknowledgement
Medical writing assistance was provided by John Bilbruck PhD, ProScribe – part of the Envision Pharma Group.
Legal entity responsible for the study
Eli Lilly and Company.
Funding
Eli Lilly and Company.
Disclosure
E.B. Garon: Research grant/Funding (institution), To institution for clinical trial: Eli Lilly and Company; Research grant/Funding (institution), To institution for clinical trial: AstraZeneca; Research grant/Funding (institution), To institution for clinical trial: BMS; Research grant/Funding (institution), To institution for clinical trial: Eli Lilly and Company; Research grant/Funding (institution), To institution for clinical trial: Genentech; Research grant/Funding (institution), To institution for clinical trial: Merck; Research grant/Funding (institution), To institution for clinical trial: Novartis; Research grant/Funding (institution), To institution for clinical trial: Iovance; Research grant/Funding (institution), To institution for clinical trial: Neon; Research grant/Funding (institution), To institution for clinical trial: Dynavax; Research grant/Funding (institution), To institution for clinical trial: Mirati; Advisory/Consultancy, Advisory board: Dracen; Advisory/Consultancy, Steering committee: EMD Serono. L. Gao: Shareholder/Stockholder/Stock options: Eli Lilly and Company. S. Callies: Shareholder/Stockholder/Stock options, Full/Part-time employment: Eli Lilly and Company. A.H. Zimmermann: Shareholder/Stockholder/Stock options, Full/Part-time employment: Eli Lilly and Company. R. Walgren: Shareholder/Stockholder/Stock options, Full/Part-time employment, Patent pending: Eli Lilly and Company. C.M. Visseren-Grul: Shareholder/Stockholder/Stock options, Full/Part-time employment: Eli Lilly and Company. M. Reck: Honoraria (self), Honoraria for lectures and consultancy: AbbVie; Honoraria (self), Honoraria for lectures and consultancy: Amgen; Honoraria (self), Honoraria for lectures and consultancy: AstraZeneca; Honoraria (self), Honoraria for lectures and consultancy: BMS; Honoraria (self), Honoraria for lectures and consultancy: Boehringer Ingelheim; Honoraria (self), Honoraria for lectures and consultancy: Celgene; Honoraria (self), Honoraria for lectures and consultancy: Eli Lilly and Company; Honoraria (self), Honoraria for lectures and consultancy: Merck; Honoraria (self), Honoraria for lectures and consultancy: MSD; Honoraria (self), Honoraria for lectures and consultancy: Novartis; Honoraria (self), Honoraria for lectures and consultancy: Pfizer; Honoraria (self), Honoraria for lectures and consultancy: Roche . All other authors have declared no conflicts of interest.