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TrilynX tested xevinapant, a drug meant to make tumours more sensitive to radiation, with cisplatin chemoradiation in 730 patients with locally advanced head and neck cancer. Despite a striking phase 2 result, the phase 3 was stopped for futility in 2024 with worse outcomes on xevinapant, a reminder that early wins in this disease often do not replicate.
TrilynX, trial NCT04459715 sponsored by Merck KGaA under licence from Debiopharm and reported in 2024, tested xevinapant, a drug meant to sensitise tumours to radiation, with cisplatin chemoradiation in unresected locally advanced head and neck cancer, and it made things worse. It randomised 730 patients and was terminated on 24 June 2024 for futility at an interim analysis, with shorter event-free survival on xevinapant than placebo, attributed partly to toxicity and treatment interruptions, after a phase 2 with a striking survival benefit; development of xevinapant was discontinued and a second phase 3, X-Ray Vision, was stopped. OnCo links it to head and neck cancer, modern external beam radiotherapy and Debiopharm. It is a reminder that early wins in this disease often do not replicate, and why a promising phase 2 reversed so completely is the open question.
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.
Shares Futility analysis (stopped for futility), Data monitoring committee (DSMB, IDMC), Group sequential design, stopping rules and alpha spending, HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer) and the tag failure.
Shares Head and neck squamous cell carcinoma and the tag failure.
Shares IMRT / IGRT (modern external beam) and the tag failure.
Shares Futility analysis (stopped for futility), Group sequential design, stopping rules and alpha spending, Interim analysis, readout and data cut-off.
Shares Futility analysis (stopped for futility), Group sequential design, stopping rules and alpha spending, Interim analysis, readout and data cut-off.
Shares Futility analysis (stopped for futility), Data monitoring committee (DSMB, IDMC).
Shares Futility analysis (stopped for futility), Group sequential design, stopping rules and alpha spending, Interim analysis, readout and data cut-off.
Shares Futility analysis (stopped for futility), Data monitoring committee (DSMB, IDMC), Group sequential design, stopping rules and alpha spending.