A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data
Journal
Gastric Cancer
Journal Volume
23
Journal Issue
3
Pages
510-519
Date Issued
2020
Author(s)
Chen L.-T.
Satoh T.
Ryu M.-H.
Chao Y.
Kato K.
Chung H.C.
Chen J.-S.
Muro K.
Kang W.K.
Yoshikawa T.
Oh S.C.
Bai L.-Y.
Tamura T.
Lee K.-W.
Hamamoto Y.
Kim J.G.
Chin K.
Oh D.-Y.
Minashi K.
Cho J.Y.
Tsuda M.
Sameshima H.
Kang Y.-K.
Boku N.
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. ? 2019, The Author(s).
Subjects
Gastric cancer; Gastroesophageal junction cancer; Long-term; Nivolumab; Placebo
SDGs
Other Subjects
nivolumab; placebo; programmed death 1 ligand 1; immunological antineoplastic agent; nivolumab; adult; advanced cancer; aged; Article; controlled study; disease exacerbation; double blind procedure; drug efficacy; drug safety; drug withdrawal; esophagus cancer; female; follow up; gastroesophageal junction; human; human tissue; interstitial lung disease; Japan; maculopapular rash; major clinical study; male; overall survival; phase 3 clinical trial; pneumonia; priority journal; progression free survival; randomized controlled trial; South Korea; stomach cancer; Taiwan; treatment duration; treatment response; tumor growth; clinical trial; drug effect; esophagus tumor; gastroesophageal junction; middle aged; multicenter study; pathology; prognosis; salvage therapy; stomach tumor; survival rate; Aged; Antineoplastic Agents, Immunological; Double-Blind Method; Esophageal Neoplasms; Esophagogastric Junction; Female; Follow-Up Studies; Humans; Japan; Male; Middle Aged; Nivolumab; Prognosis; Republic of Korea; Salvage Therapy; Stomach Neoplasms; Survival Rate; Taiwan
Publisher
Springer
Type
journal article