A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data

Li Tzong Chen, Taroh Satoh, Min Hee Ryu, Yee Chao, Ken Kato, Hyun Cheol Chung, Jen Shi Chen, Kei Muro, Won Ki Kang, Kun Huei Yeh, Takaki Yoshikawa, Sang Cheul Oh, Li Yuan Bai, Takao Tamura, Keun Wook Lee, Yasuo Hamamoto, Jong Gwang Kim, Keisho Chin, Do Youn Oh, Keiko MinashiJae Yong Cho, Masahiro Tsuda, Hiroki Sameshima, Yoon Koo Kang, Narikazu Boku

Research output: Contribution to journalArticle

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.

Original languageEnglish
JournalGastric Cancer
DOIs
Publication statusAccepted/In press - 2019 Jan 1

Fingerprint

Esophagogastric Junction
Stomach
Survival
Neoplasms
Placebos
Survival Rate
Ligands
Republic of Korea
nivolumab
Taiwan
Japan
Confidence Intervals
Safety
Drug Therapy

Keywords

  • Gastric cancer
  • Gastroesophageal junction cancer
  • Long-term
  • Nivolumab
  • Placebo

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2) : 2-year update data. / 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; Minashi, Keiko; Cho, Jae Yong; Tsuda, Masahiro; Sameshima, Hiroki; Kang, Yoon Koo; Boku, Narikazu.

In: Gastric Cancer, 01.01.2019.

Research output: Contribution to journalArticle

Chen, LT, Satoh, T, Ryu, MH, Chao, Y, Kato, K, Chung, HC, Chen, JS, Muro, K, Kang, WK, Yeh, KH, Yoshikawa, T, Oh, SC, Bai, LY, Tamura, T, Lee, KW, Hamamoto, Y, Kim, JG, Chin, K, Oh, DY, Minashi, K, Cho, JY, Tsuda, M, Sameshima, H, Kang, YK & Boku, N 2019, 'A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data', Gastric Cancer. https://doi.org/10.1007/s10120-019-01034-7
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 ; Minashi, Keiko ; Cho, Jae Yong ; Tsuda, Masahiro ; Sameshima, Hiroki ; Kang, Yoon Koo ; Boku, Narikazu. / A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2) : 2-year update data. In: Gastric Cancer. 2019.
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title = "A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data",
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.",
keywords = "Gastric cancer, Gastroesophageal junction cancer, Long-term, Nivolumab, Placebo",
author = "Chen, {Li Tzong} and Taroh Satoh and Ryu, {Min Hee} and Yee Chao and Ken Kato and Chung, {Hyun Cheol} and Chen, {Jen Shi} and Kei Muro and Kang, {Won Ki} and Yeh, {Kun Huei} and Takaki Yoshikawa and Oh, {Sang Cheul} and Bai, {Li Yuan} and Takao Tamura and Lee, {Keun Wook} and Yasuo Hamamoto and Kim, {Jong Gwang} and Keisho Chin and Oh, {Do Youn} and Keiko Minashi and Cho, {Jae Yong} and Masahiro Tsuda and Hiroki Sameshima and Kang, {Yoon Koo} and Narikazu Boku",
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month = "1",
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TY - JOUR

T1 - A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2)

T2 - 2-year update data

AU - Chen, Li Tzong

AU - Satoh, Taroh

AU - Ryu, Min Hee

AU - Chao, Yee

AU - Kato, Ken

AU - Chung, Hyun Cheol

AU - Chen, Jen Shi

AU - Muro, Kei

AU - Kang, Won Ki

AU - Yeh, Kun Huei

AU - Yoshikawa, Takaki

AU - Oh, Sang Cheul

AU - Bai, Li Yuan

AU - Tamura, Takao

AU - Lee, Keun Wook

AU - Hamamoto, Yasuo

AU - Kim, Jong Gwang

AU - Chin, Keisho

AU - Oh, Do Youn

AU - Minashi, Keiko

AU - Cho, Jae Yong

AU - Tsuda, Masahiro

AU - Sameshima, Hiroki

AU - Kang, Yoon Koo

AU - Boku, Narikazu

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

KW - Gastric cancer

KW - Gastroesophageal junction cancer

KW - Long-term

KW - Nivolumab

KW - Placebo

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U2 - 10.1007/s10120-019-01034-7

DO - 10.1007/s10120-019-01034-7

M3 - Article

C2 - 31863227

AN - SCOPUS:85077072708

JO - Gastric Cancer

JF - Gastric Cancer

SN - 1436-3291

ER -