1. A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data.
- Author
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Chen, Li-Tzong, Satoh, Taroh, Ryu, Min-Hee, Chao, Yee, Kato, Ken, Chung, Hyun Cheol, Chen, Jen-Shi, Muro, Kei, Kang, Won Ki, Yeh, Kun-Huei, Yoshikawa, Takaki, Oh, Sang Cheul, Bai, Li-Yuan, Tamura, Takao, Lee, Keun-Wook, Hamamoto, Yasuo, Kim, Jong Gwang, Chin, Keisho, Oh, Do-Youn, and Minashi, Keiko
- Subjects
ESOPHAGOGASTRIC junction ,ESOPHAGEAL cancer ,CANCER ,CONFIDENCE intervals - Abstract
Background: Nivolumab showed improvement in overall survival (OS) in ATTRACTION-2, the first phase 3 study in patients with gastric/gastroesophageal junction (G/GEJ) cancer treated with ≥ 2 chemotherapy regimens. The 2-year follow-up results of ATTRACTION-2 are presented herein. Methods: ATTRACTION-2 was a randomized, double-blind, placebo-controlled, phase 3 trial (49 sites; Japan, South Korea, and Taiwan). The median (min–max) follow-up period was 27.3 (24.1–36.3) months. The primary endpoint was OS. A subanalysis of OS was performed based on best overall response and tumor-programmed death ligand-1 (PD-L1) expression status. Results: Overall, 493 of 601 screened patients were randomized (2:1) to receive nivolumab (330) or placebo (163). OS (median [95% confidence interval; CI]) was significantly longer in the nivolumab group (5.26 [4.60–6.37] vs 4.14 [3.42–4.86] months in placebo group) at the 2-year follow-up (hazard ratio [95% CI], 0.62 [0.51–0.76]; P < 0.0001). A higher OS rate was observed in the nivolumab vs placebo group at 1 (27.3% vs 11.6%) and 2 years (10.6% vs 3.2%). The OS benefit was observed regardless of tumor PD-L1 expression. Among patients with a complete or partial response (CR or PR) in the nivolumab group, the median OS (95% CI) was 26.6 (21.65—not applicable) months; the OS rates at 1 and 2 years were 87.1% and 61.3%, respectively. No new safety signals were identified. Conclusions: Nivolumab treatment resulted in clinically meaningful long-term improvements in OS in patients with previously treated G/GEJ cancer. The long-term survival benefit of nivolumab was most evident in patients with a CR or PR. [ABSTRACT FROM AUTHOR]
- Published
- 2020
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