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TrilynX

Xevinapant or placebo plus platinum-based chemoradiotherapy in unresected locally advanced squamous cell carcinoma of the head and neck

Phase 3N = 730NCT04459715

Population
Unresected locally advanced squamous cell carcinoma of the head and neck (oropharynx p16-negative only, hypopharynx, larynx)
Design
Randomised, double-blind phase 3 study. 730 patients with unresected locally advanced SCCHN (oropharynx p16-negative only, hypopharynx or larynx) were randomly assigned 1:1 to six cycles of oral xevinapant 200 mg per day or matched placebo (days 1-14 of a 21-day cycle) plus chemoradiotherapy for the first three cycles (cisplatin 100 mg per square metre every cycle and intensity-modulated radiotherapy 70 Gy in 35 fractions). The primary end point was event-free survival assessed by a blinded independent review committee.
Primary endpoint
EFS
Arms
  • Xevinapant plus chemoradiotherapy (experimental, n = 364): Oral xevinapant 200 mg per day with cisplatin and radiotherapy
  • Placebo plus chemoradiotherapy (control, n = 366): Placebo with cisplatin and radiotherapy
People
Bourhis J, senior author Schoenfeld JD
EFSHR 1.33 (95% CI 1.05–1.67)Δ median EFS−13.7 monthsOSHR 1.39 (95% CI 1.04–1.86)
Show the numbers
Results reported for TrilynX
EndpointAnalysisXevinapant plus chemoradiotherapyPlacebo plus chemoradiotherapyEffect
EFSRandomised patients (N = 730)primaryBourhis 2025median 19.4 monthsmedian 33.1 monthsHR 1.33 (95% CI 1.05–1.67)P=0.9919Event-free survival was shorter with xevinapant. The 95% CIs for the medians (14.5 to not estimable; 21.0 to not estimable) have an upper bound that cannot be entered as a number.
OSRandomised patients (N = 730)primaryBourhis 2025——HR 1.39 (95% CI 1.04–1.86)Secondary end point; the abstract states overall survival was worse in the xevinapant arm. The hazard ratio is for death with xevinapant relative to placebo.
Results reported for TrilynX
EndpointAnalysisXevinapant plus chemoradiotherapyPlacebo plus chemoradiotherapyEffect
EFSRandomised patients (N = 730)primaryBourhis 2025median 19.4 monthsmedian 33.1 monthsHR 1.33 (95% CI 1.05–1.67)P=0.9919Event-free survival was shorter with xevinapant. The 95% CIs for the medians (14.5 to not estimable; 21.0 to not estimable) have an upper bound that cannot be entered as a number.
OSRandomised patients (N = 730)primaryBourhis 2025——HR 1.39 (95% CI 1.04–1.86)Secondary end point; the abstract states overall survival was worse in the xevinapant arm. The hazard ratio is for death with xevinapant relative to placebo.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
EFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
EFS1.331.05–1.67
OS1.391.04–1.86
Illustrative — modelled from reported values, not trial data. EFS, primary.
0%25%50%75%100%020406080Months (modelled)
  • Xevinapant plus chemoradiotherapy (experimental)
  • Placebo plus chemoradiotherapy (control)

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

Data table (modelled values)
MonthsXevinapant plus chemoradiotherapyPlacebo plus chemoradiotherapy
0100.0%100.0%
2147.2%64.4%
4123.1%42.4%
6210.9%27.3%
835.2%17.6%
Primary publication: Bourhis J, Licitra LF, Burtness B, Psyrri A, Haddad R, Harrington K, et al. Xevinapant or Placebo Plus Platinum-Based Chemoradiotherapy in Unresected Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TrilynX): A Randomized, Phase III Study. J Clin Oncol. 2025;43(29):3209-3220. PubMedDOI

Appears in

Sources

  1. Bourhis J, Licitra LF, Burtness B, Psyrri A, Haddad R, Harrington K, et al. Xevinapant or Placebo Plus Platinum-Based Chemoradiotherapy in Unresected Locally Advanced Squamous Cell Carcinoma of the Head and Neck (TrilynX): A Randomized, Phase III Study. J Clin Oncol. 2025;43(29):3209-3220.

    PubMedDOI