RAINBOW-Asia: A randomized, multicenter, double-blind, phase III study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in the treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma following disease progression on first-line chemotherapy with platinum and fluoropyrimidine.

Authors

Rui-Hua Xu

Rui-hua Xu

Sun Yat-sen University Cancer Centre, Guangzhou, China

Rui-hua Xu , Yan-Qiao Zhang , Hongming Pan , Ji Feng Feng , Tao Zhang , Tianshu Liu , Yanru Qin , Rubing Han , Wanli Zhang , Lin Shen

Organizations

Sun Yat-sen University Cancer Centre, Guangzhou, China, Harbin Medical University Cancer Hospital, Harbin, China, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China, Jiangsu Cancer Hospital, Jiangsu, China, Cancer Center, Union Hospital, Tongji Medical College, Huazhong Universtiy of Science and Technology, Wuhan, China, Zhongshan Hospital, Fudan University, Shanghai, China, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China, Eli Lilly and Company, Shanghai, China, Peking University Cancer Hospital & Institute, Beijing, China

Research Funding

Pharmaceutical/Biotech Company
Eli Lilly and Company

Background: Ramucirumab (RAM), a fully human IgG1 monoclonal antibody targeting vascular endothelial growth factor receptor 2, has been approved in combination with paclitaxel (PTX) in patients with advanced gastric cancer in the second-line setting outside of China in around 80 countries based on the significant overall survival (OS) benefit in the global phase 3 RAINBOW study. RAINBOW-Asia was a bridging study of RAINBOW to evaluate the efficacy and safety of RAM in a predominantly Chinese population. Methods: Patients with advanced gastric or gastro-esophageal junction (GEJ) adenocarcinoma who experienced disease progression on first-line chemotherapy (platinum plus fluoropyrimidine with or without an anthracycline) were randomized at a 2:1 ratio to receive RAM (8 mg/kg) on day 1 and 15 plus PTX (80 mg/m²) on day 1, 8, and 15 of a 28-day cycle or placebo (PL) plus PTX. Randomization was stratified by ECOG Performance Status (0 versus 1) and peritoneal metastases (yes versus no). The co-primary endpoints were PFS and OS. Results: From Mar 2017 to Jun 2020, 440 pts were randomized (RAM+PTX: 294; PL+PTX: 146). Median PFS was significantly improved with RAM+PTX compared to PL+PTX (4.14m vs. 3.15m; HR = 0.765 [95% CI: 0.613 to 0.955]; p = 0.0184). Median OS was 8.71m with RAM+PTX and 7.92m with PL+PTX (HR = 0.963 [95% CI: 0.771 to 1.203]; p = 0.7426). Grade ≥ 3 treatment-emergent adverse events (TEAEs) occurring in > 5% of patients with RAM+PTX were: neutrophil count decreased (54.3% RAM+PTX; 38.6% PL+PTX), white blood cell count decreased (43.3% vs. 29.0%), anaemia (15.7% vs. 16.6%), hypertension (7.2% vs. 6.2%), and febrile neutropenia (6.1% vs. 0.7%). Conclusions: The combination of RAM+PTX as 2nd-line therapy demonstrated a statistically significant PFS benefit, and OS benefit consistent with RAINBOW study in a predominantly Chinese population with advanced gastric and GEJ cancer. The safety profile of RAM was consistent with previous studies. No new safety signal was observed. Clinical trial information: NCT02898077

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Abstract Details

Meeting

2021 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session: Esophageal and Gastric Cancer

Track

Esophageal and Gastric Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT02898077

Citation

J Clin Oncol 39, 2021 (suppl 3; abstr 199)

DOI

10.1200/JCO.2021.39.3_suppl.199

Abstract #

199

Poster Bd #

Online Only

Abstract Disclosures