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KEYNOTE-061

A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061)

Phase 3N = 592NCT02370498

Population
Patients with advanced gastric or gastro-oesophageal junction cancer that progressed on first-line chemotherapy with a platinum and a fluoropyrimidine; efficacy analysis in the PD-L1 CPS 1 or more population.
Design
Randomised open-label phase 3 trial at 148 centres in 30 countries; 592 patients enrolled, randomised 1:1 to pembrolizumab 200 mg every 3 weeks for up to 2 years or standard-dose paclitaxel. Primary endpoints: overall survival and progression-free survival in patients with PD-L1 CPS 1 or more (395 patients: 196 and 199). One-sided significance threshold for overall survival p=0.0135.
Primary endpoint
OS, PFS
Arms
  • Paclitaxel (control, n = 199): Standard-dose paclitaxel
  • Pembrolizumab (experimental, n = 196): Pembrolizumab 200 mg every 3 weeks for up to 2 years
People
Shitara K, KEYNOTE-061 investigators
OSHR 0.82 (95% CI 0.66–1.03)Δ median OS+0.8 monthsPFSHR 1.27 (95% CI 1.03–1.57)Δ median PFS−2.6 months
Show the numbers
Results reported for KEYNOTE-061
EndpointAnalysisPembrolizumabPaclitaxelEffect
OSPD-L1 CPS 1 or moreprimaryShitara 2018median 9.1 months (6.2–10.7)median 8.3 months (7.6–9.0)HR 0.82 (95% CI 0.66–1.03)P=0.0421 (one-sided)Data cutoff 26 October 2017; the prespecified one-sided significance threshold for overall survival was p=0.0135, which was not reached.
PFSPD-L1 CPS 1 or moreprimaryShitara 2018median 1.5 months (1.4–2.0)median 4.1 months (3.1–4.2)HR 1.27 (95% CI 1.03–1.57)
Results reported for KEYNOTE-061
EndpointAnalysisPembrolizumabPaclitaxelEffect
OSPD-L1 CPS 1 or moreprimaryShitara 2018median 9.1 months (6.2–10.7)median 8.3 months (7.6–9.0)HR 0.82 (95% CI 0.66–1.03)P=0.0421 (one-sided)Data cutoff 26 October 2017; the prespecified one-sided significance threshold for overall survival was p=0.0135, which was not reached.
PFSPD-L1 CPS 1 or moreprimaryShitara 2018median 1.5 months (1.4–2.0)median 4.1 months (3.1–4.2)HR 1.27 (95% CI 1.03–1.57)
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.820.66–1.03
PFS1.271.03–1.57
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Pembrolizumab (experimental)
  • Paclitaxel (control)

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

Data table (modelled values)
MonthsPembrolizumabPaclitaxel
0100.0%100.0%
663.3%60.6%
1143.3%39.9%
1727.4%24.2%
2317.3%14.6%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0246810Months (modelled)
  • Pembrolizumab (experimental)
  • Paclitaxel (control)

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

Data table (modelled values)
MonthsPembrolizumabPaclitaxel
0100.0%100.0%
325.0%60.2%
59.9%42.9%
82.5%25.9%
101.0%18.4%
Primary publication: Shitara K, Özgüroğlu M, Bang YJ, Di Bartolomeo M, Mandalà M, Ryu MH, et al. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. Lancet. 2018;392(10142):123-133. PubMedDOI

Appears in

Sources

  1. Shitara K, Özgüroğlu M, Bang YJ, Di Bartolomeo M, Mandalà M, Ryu MH, et al. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. Lancet. 2018;392(10142):123-133.

    PubMedDOI