CheckMate-032 study

Efficacy and safety of nivolumab and nivolumab plus ipilimumab in patients with metastatic esophagogastric cancer

Yelena Y. Janjigian, Johanna Bendell, Emiliano Calvo, Joseph W. Kim, Paolo A. Ascierto, Padmanee Sharma, Patrick A. Ott, Katriina Peltola, Dirk Jaeger, Jeffry Evans, Filippo De Braud, Ian Chau, Christopher T. Harbison, Cecile Dorange, Marina Tschaika, Dung Le

Research output: Contribution to journalArticle

Abstract

Purpose Metastatic esophagogastric cancer treatments after failure of second-line chemotherapy are limited. Nivolumab demonstrated superior overall survival (OS) versus placebo in Asian patients with advanced gastric or gastroesophageal junction cancers. We assessed the safety and efficacy of nivolumab and nivolumab plus ipilimumab in Western patients with chemotherapy-refractory esophagogastric cancers. Patients and Methods Patients with locally advanced or metastatic chemotherapy-refractory gastric, esophageal, or gastroesophageal junction cancer from centers in the United States and Europe received nivolumab or nivolumab plus ipilimumab. The primary end point was objective response rate. The association of tumor programmed death-ligand 1 status with response and survival was also evaluated. Results Of 160 treated patients (59 with nivolumab 3mg/kg, 49with nivolumab 1mg/kg plus ipilimumab 3mg/kg, 52 with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg), 79% had received two or more prior therapies. At the data cutoff, investigator-assessed objective response rates were 12% (95% CI, 5% to 23%), 24% (95% CI, 13% to 39%), and 8% (95%CI, 2%to 19%) in the three groups, respectively. Responseswere observed regardless of tumor programmed death-ligand 1 status. With a median follow-up of 28, 24, and 22 months across the three groups, 12-month progression-free survival rates were 8%, 17%, and 10%, respectively; 12-month OS rates were 39%, 35%, and 24%, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 47%, and 27% of patients in the three groups, respectively. Conclusion Nivolumab and nivolumab plus ipilimumab demonstrated clinically meaningful antitumor activity, durable responses, encouraging long-term OS, and a manageable safety profile in patients with chemotherapy-refractory esophagogastric cancer. Phase III studies evaluating nivolumab or nivolumab plus ipilimumab in earlier lines of therapy for esophagogastric cancers are underway.

Original languageEnglish (US)
Pages (from-to)2836-2844
Number of pages9
JournalJournal of Clinical Oncology
Volume36
Issue number28
DOIs
StatePublished - Oct 1 2018

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Safety
Neoplasms
Drug Therapy
Esophagogastric Junction
Survival
ipilimumab
nivolumab
Stomach
Survival Rate
Ligands
Secondary Prevention
Treatment Failure
Disease-Free Survival
Placebos
Research Personnel
Therapeutics

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

CheckMate-032 study : Efficacy and safety of nivolumab and nivolumab plus ipilimumab in patients with metastatic esophagogastric cancer. / Janjigian, Yelena Y.; Bendell, Johanna; Calvo, Emiliano; Kim, Joseph W.; Ascierto, Paolo A.; Sharma, Padmanee; Ott, Patrick A.; Peltola, Katriina; Jaeger, Dirk; Evans, Jeffry; De Braud, Filippo; Chau, Ian; Harbison, Christopher T.; Dorange, Cecile; Tschaika, Marina; Le, Dung.

In: Journal of Clinical Oncology, Vol. 36, No. 28, 01.10.2018, p. 2836-2844.

Research output: Contribution to journalArticle

Janjigian, YY, Bendell, J, Calvo, E, Kim, JW, Ascierto, PA, Sharma, P, Ott, PA, Peltola, K, Jaeger, D, Evans, J, De Braud, F, Chau, I, Harbison, CT, Dorange, C, Tschaika, M & Le, D 2018, 'CheckMate-032 study: Efficacy and safety of nivolumab and nivolumab plus ipilimumab in patients with metastatic esophagogastric cancer', Journal of Clinical Oncology, vol. 36, no. 28, pp. 2836-2844. https://doi.org/10.1200/JCO.2017.76.6212
Janjigian, Yelena Y. ; Bendell, Johanna ; Calvo, Emiliano ; Kim, Joseph W. ; Ascierto, Paolo A. ; Sharma, Padmanee ; Ott, Patrick A. ; Peltola, Katriina ; Jaeger, Dirk ; Evans, Jeffry ; De Braud, Filippo ; Chau, Ian ; Harbison, Christopher T. ; Dorange, Cecile ; Tschaika, Marina ; Le, Dung. / CheckMate-032 study : Efficacy and safety of nivolumab and nivolumab plus ipilimumab in patients with metastatic esophagogastric cancer. In: Journal of Clinical Oncology. 2018 ; Vol. 36, No. 28. pp. 2836-2844.
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abstract = "Purpose Metastatic esophagogastric cancer treatments after failure of second-line chemotherapy are limited. Nivolumab demonstrated superior overall survival (OS) versus placebo in Asian patients with advanced gastric or gastroesophageal junction cancers. We assessed the safety and efficacy of nivolumab and nivolumab plus ipilimumab in Western patients with chemotherapy-refractory esophagogastric cancers. Patients and Methods Patients with locally advanced or metastatic chemotherapy-refractory gastric, esophageal, or gastroesophageal junction cancer from centers in the United States and Europe received nivolumab or nivolumab plus ipilimumab. The primary end point was objective response rate. The association of tumor programmed death-ligand 1 status with response and survival was also evaluated. Results Of 160 treated patients (59 with nivolumab 3mg/kg, 49with nivolumab 1mg/kg plus ipilimumab 3mg/kg, 52 with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg), 79{\%} had received two or more prior therapies. At the data cutoff, investigator-assessed objective response rates were 12{\%} (95{\%} CI, 5{\%} to 23{\%}), 24{\%} (95{\%} CI, 13{\%} to 39{\%}), and 8{\%} (95{\%}CI, 2{\%}to 19{\%}) in the three groups, respectively. Responseswere observed regardless of tumor programmed death-ligand 1 status. With a median follow-up of 28, 24, and 22 months across the three groups, 12-month progression-free survival rates were 8{\%}, 17{\%}, and 10{\%}, respectively; 12-month OS rates were 39{\%}, 35{\%}, and 24{\%}, respectively. Treatment-related grade 3/4 adverse events were reported in 17{\%}, 47{\%}, and 27{\%} of patients in the three groups, respectively. Conclusion Nivolumab and nivolumab plus ipilimumab demonstrated clinically meaningful antitumor activity, durable responses, encouraging long-term OS, and a manageable safety profile in patients with chemotherapy-refractory esophagogastric cancer. Phase III studies evaluating nivolumab or nivolumab plus ipilimumab in earlier lines of therapy for esophagogastric cancers are underway.",
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T2 - Efficacy and safety of nivolumab and nivolumab plus ipilimumab in patients with metastatic esophagogastric cancer

AU - Janjigian, Yelena Y.

AU - Bendell, Johanna

AU - Calvo, Emiliano

AU - Kim, Joseph W.

AU - Ascierto, Paolo A.

AU - Sharma, Padmanee

AU - Ott, Patrick A.

AU - Peltola, Katriina

AU - Jaeger, Dirk

AU - Evans, Jeffry

AU - De Braud, Filippo

AU - Chau, Ian

AU - Harbison, Christopher T.

AU - Dorange, Cecile

AU - Tschaika, Marina

AU - Le, Dung

PY - 2018/10/1

Y1 - 2018/10/1

N2 - Purpose Metastatic esophagogastric cancer treatments after failure of second-line chemotherapy are limited. Nivolumab demonstrated superior overall survival (OS) versus placebo in Asian patients with advanced gastric or gastroesophageal junction cancers. We assessed the safety and efficacy of nivolumab and nivolumab plus ipilimumab in Western patients with chemotherapy-refractory esophagogastric cancers. Patients and Methods Patients with locally advanced or metastatic chemotherapy-refractory gastric, esophageal, or gastroesophageal junction cancer from centers in the United States and Europe received nivolumab or nivolumab plus ipilimumab. The primary end point was objective response rate. The association of tumor programmed death-ligand 1 status with response and survival was also evaluated. Results Of 160 treated patients (59 with nivolumab 3mg/kg, 49with nivolumab 1mg/kg plus ipilimumab 3mg/kg, 52 with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg), 79% had received two or more prior therapies. At the data cutoff, investigator-assessed objective response rates were 12% (95% CI, 5% to 23%), 24% (95% CI, 13% to 39%), and 8% (95%CI, 2%to 19%) in the three groups, respectively. Responseswere observed regardless of tumor programmed death-ligand 1 status. With a median follow-up of 28, 24, and 22 months across the three groups, 12-month progression-free survival rates were 8%, 17%, and 10%, respectively; 12-month OS rates were 39%, 35%, and 24%, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 47%, and 27% of patients in the three groups, respectively. Conclusion Nivolumab and nivolumab plus ipilimumab demonstrated clinically meaningful antitumor activity, durable responses, encouraging long-term OS, and a manageable safety profile in patients with chemotherapy-refractory esophagogastric cancer. Phase III studies evaluating nivolumab or nivolumab plus ipilimumab in earlier lines of therapy for esophagogastric cancers are underway.

AB - Purpose Metastatic esophagogastric cancer treatments after failure of second-line chemotherapy are limited. Nivolumab demonstrated superior overall survival (OS) versus placebo in Asian patients with advanced gastric or gastroesophageal junction cancers. We assessed the safety and efficacy of nivolumab and nivolumab plus ipilimumab in Western patients with chemotherapy-refractory esophagogastric cancers. Patients and Methods Patients with locally advanced or metastatic chemotherapy-refractory gastric, esophageal, or gastroesophageal junction cancer from centers in the United States and Europe received nivolumab or nivolumab plus ipilimumab. The primary end point was objective response rate. The association of tumor programmed death-ligand 1 status with response and survival was also evaluated. Results Of 160 treated patients (59 with nivolumab 3mg/kg, 49with nivolumab 1mg/kg plus ipilimumab 3mg/kg, 52 with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg), 79% had received two or more prior therapies. At the data cutoff, investigator-assessed objective response rates were 12% (95% CI, 5% to 23%), 24% (95% CI, 13% to 39%), and 8% (95%CI, 2%to 19%) in the three groups, respectively. Responseswere observed regardless of tumor programmed death-ligand 1 status. With a median follow-up of 28, 24, and 22 months across the three groups, 12-month progression-free survival rates were 8%, 17%, and 10%, respectively; 12-month OS rates were 39%, 35%, and 24%, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 47%, and 27% of patients in the three groups, respectively. Conclusion Nivolumab and nivolumab plus ipilimumab demonstrated clinically meaningful antitumor activity, durable responses, encouraging long-term OS, and a manageable safety profile in patients with chemotherapy-refractory esophagogastric cancer. Phase III studies evaluating nivolumab or nivolumab plus ipilimumab in earlier lines of therapy for esophagogastric cancers are underway.

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