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JAVELIN Head and Neck 100

Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in locally advanced squamous cell carcinoma of the head and neck

Phase 3N = 697NCT02952586

Population
Previously untreated locally advanced squamous cell carcinoma of the head and neck, suitable for chemoradiotherapy
Design
Randomised, double-blind, placebo-controlled phase 3 study at 196 centres in 22 countries. 697 patients with previously untreated locally advanced SCCHN (oropharynx, hypopharynx, larynx or oral cavity; unselected for PD-L1) were randomly assigned 1:1 to avelumab 10 mg per kilogram every 2 weeks or placebo with cisplatin (100 mg per square metre every 3 weeks) and intensity-modulated radiotherapy (70 Gy), after a single lead-in dose, followed by maintenance for up to 12 months. The primary endpoint was investigator-assessed progression-free survival in all randomly assigned patients. Enrolment was stopped and the trial discontinued.
Primary endpoint
PFS
Arms
  • Avelumab plus chemoradiotherapy (experimental, n = 350): Avelumab 10 mg per kilogram every 2 weeks with cisplatin and radiotherapy, then maintenance
  • Placebo plus chemoradiotherapy (control, n = 347): Placebo with cisplatin and radiotherapy, then maintenance placebo
People
Lee NY, senior author Cohen E
PFSHR 1.21 (95% CI 0.93–1.57)
Show the numbers
Results reported for JAVELIN Head and Neck 100
EndpointAnalysisAvelumab plus chemoradiotherapyPlacebo plus chemoradiotherapyEffect
PFSAll randomly assigned patients (N = 697)primaryLee 2021——HR 1.21 (95% CI 0.93–1.57)P=0.92 (one-sided)Primary objective not met. Median progression-free survival was not reached in either group (avelumab: 95% CI 16.9 months to not estimable; placebo: 23.0 months to not estimable). Median follow-up was 14.6 months (avelumab) and 14.8 months (placebo).
Results reported for JAVELIN Head and Neck 100
EndpointAnalysisAvelumab plus chemoradiotherapyPlacebo plus chemoradiotherapyEffect
PFSAll randomly assigned patients (N = 697)primaryLee 2021——HR 1.21 (95% CI 0.93–1.57)P=0.92 (one-sided)Primary objective not met. Median progression-free survival was not reached in either group (avelumab: 95% CI 16.9 months to not estimable; placebo: 23.0 months to not estimable). Median follow-up was 14.6 months (avelumab) and 14.8 months (placebo).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS1.210.93–1.57
Primary publication: Lee NY, Ferris RL, Psyrri A, Haddad RI, Tahara M, Bourhis J, et al. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2021;22(4):450-462. PubMedDOI

Appears in

Sources

  1. Lee NY, Ferris RL, Psyrri A, Haddad RI, Tahara M, Bourhis J, et al. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2021;22(4):450-462.

    PubMedDOI