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Presidential Symposium III

LBA9_PR - Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer (EC/GEJC) following neoadjuvant chemoradiation therapy (CRT): First results of the CheckMate 577 study

Date

21 Sep 2020

Session

Presidential Symposium III

Presenters

Ronan Kelly

Citation

Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325

Authors

R.J. Kelly1, J.A. Ajani2, J. Kuzdzal3, T. Zander4, E. Van Cutsem5, G. Piessen6, G. Mendez7, J.L. Feliciano8, S. Motoyama9, A. LIÈVRE10, H. Uronis11, E. Elimova12, C. Grootscholten13, K. Geboes14, J. Zhang15, L. Zhu16, M. Lei17, K. Kondo18, J.M. Cleary19, M. Moehler20

Author affiliations

  • 1 Medical Oncology, The Charles A. Sammons Cancer Center at Baylor University Medical Center, 75246 - Dallas/US
  • 2 Gastrointestinal Medical Oncology, Division Of Cancer Medicine, The University of Texas MD Anderson Cancer Center, 77030 - Houston/US
  • 3 Thoracic Surgery, Jagiellonian University, John Paul II Hospital, 31-202 - Krakow/PL
  • 4 Internal Medicine, University Hospital Of Cologne, 50937 - Cologne/DE
  • 5 Gastroenterology / Digestive Oncology, University Hospitals Gasthuisberg, Leuven and KULeuven, 3000 - Leuven/BE
  • 6 Digestive And Oncological Surgery, Univ. Lille, Claude Huriez University Hospital, 59037 - Lille/FR
  • 7 Clinical Oncology, Fundacion Favaloro, 1093 - Bueno Aires/AR
  • 8 Medical Oncology, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, 21224 - Baltimore/US
  • 9 Esophageal Surgery, Akita University Hospital, 010-8543 - Akita/JP
  • 10 Service Des Maladies De L’appareil Digestif, CHU Pontchaillou, 35000 - Rennes/FR
  • 11 Medical Oncology, Duke Cancer Institute, 27710 - Durham/US
  • 12 Medical Oncology, Princess Margaret Cancer Centre, M5G 2M9 - Toronto/CA
  • 13 Gastrointestinal Oncology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, 1066 CX - Amsterdam/NL
  • 14 Gastroenterology, UZ Gent, 9000 - Gent/BE
  • 15 Clinical Research, Bristol-Myers Squibb Company, 08540 - Princeton/US
  • 16 Oncology Biostatistics, Bristol-Myers Squibb Company, 08540 - Princeton/US
  • 17 Clinical Pharmacology, Bristol-Myers Squibb Company, 08540 - Princeton/US
  • 18 Immuno-oncology, Bristol-Myers Squibb Company, 08540 - Princeton/US
  • 19 Medical Oncology, Dana Farber Cancer Institute, 02215 - Boston/US
  • 20 Gastroenterology / Endosonography, Johannes-Gutenberg University Clinic, 55131 - Mainz/DE
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Resources

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Abstract LBA9_PR

Background

The risk of recurrence after neoadjuvant CRT followed by surgery (trimodality therapy) remains high in EC/GEJC and there is no established adjuvant treatment. CheckMate 577 is the first global, randomized, double-blind, phase 3 study to report the efficacy and safety of a checkpoint inhibitor in the adjuvant setting after trimodality therapy for EC/GEJC.

Methods

Adults with resected (R0) stage II/III EC/GEJC who received neoadjuvant CRT and had residual pathologic disease were randomized 2:1 to nivolumab 240 mg or placebo Q2W for 16 weeks, followed by nivolumab 480 mg or placebo Q4W. Maximum treatment duration was 1 year. The primary endpoint was disease-free survival (DFS).

Results

794 patients were randomized (nivolumab, 532; placebo, 262). Approximately 70% of patients had adenocarcinoma and almost 60% had a pathologic lymph node status ≥ypN1 in both groups. At a pre-specified interim analysis, adjuvant nivolumab showed a statistically significant improvement in DFS vs placebo (HR 0.69 [96.4% CI 0.56 -0.86]; P = 0.0003); median DFS was doubled (22.4 vs 11.0 mo, respectively; Table). The majority of treatment-related adverse events (TRAEs) were grade 1 or 2. The frequency of serious TRAEs and TRAEs leading to discontinuation were ≤ 9% with nivolumab and 3% with placebo (Table). Data including DFS rate and an analysis of DFS across pre-specified subgroups will be presented. Table: LBA9_PR

Efficacy NivolumabN = 532 PlaceboN = 262
Median DFS, mo (95% CI) 22.4 (16.6–34.0) 11.0 (8.3–14.3)
HR (96.4% CI; P value) 0.69 (0.56–0.86; P = 0.0003)
Safety, n (%) N = 532 N = 260
Any-grade TRAEs 376 (71) 119 (46)
Grade 3–4 71 (13) 15 (6)
Serious TRAEs 40 (8) 7 (3)
Grade 3–4 29 (5) 3 (1)
TRAEs leading to discontinuation 48 (9) 8 (3)
Grade 3–4 26 (5) 7 (3)

Conclusions

Adjuvant nivolumab is the first therapeutic to provide a statistically significant and clinically meaningful improvement in DFS vs placebo and a well-tolerated safety profile in patients with resected EC/GEJC, who have received neoadjuvant CRT. These results represent the first treatment advance in many years for these patients, potentially establishing adjuvant nivolumab as a new standard of care.

Clinical trial identification

NCT02743494.

Editorial acknowledgement

Writing and editorial assistance was provided by Patricia McChesney, PhD, CMPP, of Parexel International, funded by Bristol-Myers Squibb Company.

Legal entity responsible for the study

Bristol-Myers Squibb Company.

Funding

Bristol-Myers Squibb Company.

Disclosure

R.J. Kelly: Advisory/Consultancy, Research grant/Funding (institution), Advisory Board Member: Bristol Myers Squibb; Advisory/Consultancy, Advisory Board Member: Merck; Advisory/Consultancy, Advisory Board Member: Novartis ; Advisory/Consultancy, Research grant/Funding (institution), Advisory Board Member: Eli Lilly; Advisory/Consultancy, Advisory Board Member: Pieris Pharmaceuticals; Advisory/Consultancy, Advisory Board Member: Cardinal Health; Advisory/Consultancy, Advisory Board Member: Astellas; Advisory/Consultancy, Advisory Board Member: Takeda; Advisory/Consultancy, Advisory Board Member: Ono Pharmaceuticals; Advisory/Consultancy, Advisory Board Member: AstraZeneca. J.A. Ajani: Advisory/Consultancy, Research grant/Funding (institution): Bristol Myers Squibb. J. Kuzdzal: Research grant/Funding (institution): Bristol Myers Squibb; Research grant/Funding (institution): Roche. T. Zander: Advisory/Consultancy, advisory boards: Bristol Myers Squibb; Advisory/Consultancy, advisory boards: MSD; Advisory/Consultancy, advisory boards: Roche; Advisory/Consultancy, advisory boards: Lilly; Advisory/Consultancy, advisory boards: Novartis. E. Van Cutsem: Advisory/Consultancy, Research grant/Funding (institution): Bayer; Advisory/Consultancy, Research grant/Funding (institution): Lilly; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy, Research grant/Funding (institution): Servier; Advisory/Consultancy, Research grant/Funding (institution): Bristol Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Celgene; Advisory/Consultancy: Merck Sharp & Dolme; Advisory/Consultancy, Research grant/Funding (institution): Merck KGaA; Advisory/Consultancy, Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Boehringer Ingelheim; Research grant/Funding (institution): Ipsen; Research grant/Funding (institution): Merck. G. Piessen: Honoraria (self): MSD; Honoraria (self): Roche; Honoraria (self): Amgen. J.L. Feliciano: Advisory/Consultancy, Research grant/Funding (institution), consulting fees: AstraZeneca; Advisory/Consultancy, consulting fees: Genentech; Advisory/Consultancy, Research grant/Funding (institution), consulting fees: Bristol Myers Squibb; Advisory/Consultancy, consulting fees: Merck; Advisory/Consultancy, consulting fees: Eli Lilly. A. Lièvre: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, lectures, consulting, travel support: AAA; Honoraria (self), Advisory/Consultancy, lectures, consulting: Amgen; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, lectures, consulting, travel support: Bayer; Honoraria (self), Travel/Accommodation/Expenses, lectures, travel support: Bristol Myers Squibb; Honoraria (self), lectures: Celgene; Honoraria (self), lectures: HalioDX; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, lectures, consulting, travel support: Ipsen; Honoraria (self), Advisory/Consultancy, lectures, consulting: Lilly; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, lectures, consulting, travel support: Merck; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, lectures, consulting, travel support: Novartis; Honoraria (self), Advisory/Consultancy, lectures, consulting: Pierre Fabre; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, lectures, consulting, travel support: Sandoz; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, lectures, consulting, travel support: Servier; Travel/Accommodation/Expenses, equipment supply: Integragen; Advisory/Consultancy, Travel/Accommodation/Expenses, consulting, travel support: Incyte; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses, lectures, consulting, travel support: Roche; Travel/Accommodation/Expenses, travel support: Pfizer. H. Uronis: Research grant/Funding (institution): Macrogenics; Research grant/Funding (institution): Lycera; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Advaxis; Research grant/Funding (institution): Bristol Myers Squibb. E. Elimova: Advisory/Consultancy, Research grant/Funding (institution): Bristol Myers Squibb; Advisory/Consultancy, Research grant/Funding (institution): Zymeworks; Spouse/Financial dependant: Merck Vaccines. C. Grootscholten: Research grant/Funding (institution): Bristol Myers Squibb. J. Zhang: Full/Part-time employment: Bristol Myers Squibb. L. Zhu: Full/Part-time employment: Bristol Myers Squibb. M. Lei: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol Myers Squibb. K. Kondo: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bristol Myers Squibb. J.M. Cleary: Advisory/Consultancy, Travel/Accommodation/Expenses: Bristol Myers Squibb; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Tesaro; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Esperas Pharma. M. Moehler: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses, Adboards: Bristol Myers Squibb. All other authors have declared no conflicts of interest.

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