OnCo
trialsTrialNegative

TrilynX

A promising phase 2 drug that sensitises tumours to radiation made things worse in phase 3, a reminder that early wins in this disease often do not replicate.

Terminated 24 June 2024 for futility at interim analysis; median EFS 19.4 months with xevinapant versus 33.1 with placebo (JCO 2025), attributed partly to toxicity and treatment interruptions. Followed a phase 2 with a striking OS benefit. Development of xevinapant was discontinued.

Setting
Unresected locally advanced HNSCC: xevinapant + cisplatin chemoradiation vs placebo + chemoradiation
Phase
Phase 3
Sponsor
Merck KGaA (Debiopharm licence)
Registry
Headline result
EFS 19.4 vs 33.1 months (worse with xevinapant).
Reported
2024
Enrolled
730
Replication
The phase 2 result was not reproduced; a second phase 3 (X-Ray Vision) was stopped.

Outcomes

1top
In plain words
What these results mean for people, not percentages
730 people took part
Event-free survivalprimarysurrogate endpoint
  • Median 19.4 vs 33.1 months with Xevinapant + CRT compared with Placebo + CRT; about 13.7 months shorter for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: Unresected locally advanced HNSCC: xevinapant + cisplatin chemoradiation vs placebo + chemoradiation. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

730 participants enrolled.

Event-free survivalprimary
Xevinapant + CRT
19.4 mo
Placebo + CRT
33.1 mo
Source
EndpointArmnValueHR (95% CI)pSource
Event-free survivalprimaryXevinapant + CRT19.4 monthslink
Placebo + CRT33.1 months
Replication
The phase 2 result was not reproduced; a second phase 3 (X-Ray Vision) was stopped.

Connected

3top