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KEYNOTE-059

A Study of Pembrolizumab (MK-3475) in Participants With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-059/KEYNOTE-059)

Phase 2N = 259NCT02335411

Population
Recurrent or metastatic gastric or gastro-oesophageal junction adenocarcinoma (Siewert types II and III) with disease progression after two or more prior chemotherapy regimens that included a fluoropyrimidine and a platinum doublet (cohort 1).
Design
Phase 2 global open-label nonrandomised multicohort study (67 sites in 17 countries); the report covers cohort 1: 259 patients at 52 sites in 16 countries enrolled between 2 March 2015 and 26 May 2016, treated with pembrolizumab 200 mg every 3 weeks until progression, withdrawal, unacceptable toxic effects or 35 cycles. Primary endpoints: objective response rate (central review, RECIST 1.1) and safety. Median follow-up 5.8 months (range 0.5-21.6); data cutoff 16 January 2017.
Primary endpoint
ORR
Arms
  • Pembrolizumab (experimental, n = 259): Pembrolizumab 200 mg intravenously every 3 weeks
People
Fuchs CS, senior author Yoon HH
Show the numbers
Results reported for KEYNOTE-059
EndpointAnalysisPembrolizumabControlEffect
ORRAll 259 patients in the cohortObjective response rate by central radiologic review per RECIST 1.1primaryFuchs 201811.6% (8.0–16.1%)—Complete response in 2.3% (6 of 259 patients).
ORRPD-L1-positive tumours (combined positive score 1 or more, 22C3 assay; 148 patients)primaryFuchs 201815.5% (10.1–22.4%)——
ORRPD-L1-negative tumours (combined positive score below 1; 109 patients)primaryFuchs 20186.4% (2.6–12.8%)——
DORResponders in the 259-patient cohortprimaryFuchs 2018median 8.4 months—Range 1.6+ to 17.3+ months, where + indicates no progressive disease at last assessment; no confidence interval in the abstract.
Results reported for KEYNOTE-059
EndpointAnalysisPembrolizumabControlEffect
ORRAll 259 patients in the cohortObjective response rate by central radiologic review per RECIST 1.1primaryFuchs 201811.6% (8.0–16.1%)—Complete response in 2.3% (6 of 259 patients).
ORRPD-L1-positive tumours (combined positive score 1 or more, 22C3 assay; 148 patients)primaryFuchs 201815.5% (10.1–22.4%)——
ORRPD-L1-negative tumours (combined positive score below 1; 109 patients)primaryFuchs 20186.4% (2.6–12.8%)——
DORResponders in the 259-patient cohortprimaryFuchs 2018median 8.4 months—Range 1.6+ to 17.3+ months, where + indicates no progressive disease at last assessment; no confidence interval in the abstract.
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%05101520Months (modelled)
  • Pembrolizumab (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsPembrolizumab
0100.0%
566.2%
1140.3%
1626.7%
2117.7%
Primary publication: Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, et al. Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial. JAMA Oncol. 2018;4(5):e180013. PubMedDOI

Appears in

Sources

  1. Fuchs CS, Doi T, Jang RW, Muro K, Satoh T, Machado M, et al. Safety and Efficacy of Pembrolizumab Monotherapy in Patients With Previously Treated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Clinical KEYNOTE-059 Trial. JAMA Oncol. 2018;4(5):e180013.

    PubMedDOI