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JAVELIN Gastric 100

Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)

Phase 3N = 499NCT02625610

Population
Untreated, unresectable, HER2-negative, locally advanced or metastatic gastric or gastroesophageal junction cancer with no progression after induction chemotherapy.
Design
Global open-label phase 3 trial. Patients without progressive disease after 12 weeks of first-line oxaliplatin plus fluoropyrimidine chemotherapy (805 received induction) were randomly assigned 1:1 to avelumab 10 mg/kg every 2 weeks or continued chemotherapy, stratified by region (Asia versus non-Asia). Primary endpoint: overall survival after induction chemotherapy in all randomised patients or the PD-L1-positive randomised population (tumour cells 1% or more, 73-10 assay).
Primary endpoint
OS
Arms
  • Continued chemotherapy (control, n = 250): Continued oxaliplatin plus fluoropyrimidine chemotherapy
  • Avelumab maintenance (experimental, n = 249): Avelumab 10 mg/kg every 2 weeks
People
Moehler M, senior author Bang YJ
OSHR 0.91 (95% CI 0.74–1.11)Δ median OS−0.5 monthsΔ 24-month OS+6.6 points
Show the numbers
Results reported for JAVELIN Gastric 100
EndpointAnalysisAvelumab maintenanceContinued chemotherapyEffect
OSAll randomised patients after induction chemotherapyprimaryMoehler 2021median 10.4 months (9.1–12.0); 22.1% at 2 ymedian 10.9 months (9.6–12.4); 15.5% at 2 yHR 0.91 (95% CI 0.74–1.11)P=.1779Survival measured from randomisation after induction chemotherapy.
Results reported for JAVELIN Gastric 100
EndpointAnalysisAvelumab maintenanceContinued chemotherapyEffect
OSAll randomised patients after induction chemotherapyprimaryMoehler 2021median 10.4 months (9.1–12.0); 22.1% at 2 ymedian 10.9 months (9.6–12.4); 15.5% at 2 yHR 0.91 (95% CI 0.74–1.11)P=.1779Survival measured from randomisation after induction chemotherapy.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.910.74–1.11
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Avelumab maintenance (experimental)
  • Continued chemotherapy (control)

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

Data table (modelled values)
MonthsAvelumab maintenanceContinued chemotherapy
0100.0%100.0%
762.7%64.1%
1439.3%41.1%
2026.4%28.0%
2716.5%18.0%
Primary publication: Moehler M, Dvorkin M, Boku N, Özgüroğlu M, Ryu MH, Muntean AS, et al. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100. J Clin Oncol. 2021;39(9):966-977. PubMedDOI

Appears in

Sources

  1. Moehler M, Dvorkin M, Boku N, Özgüroğlu M, Ryu MH, Muntean AS, et al. Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100. J Clin Oncol. 2021;39(9):966-977.

    PubMedDOI