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Adding a PD-L1 blocker to curative chemoradiation did not help, the first of several such failures in head and neck cancer.
JAVELIN Head and Neck 100, trial NCT02952586 sponsored by Merck KGaA and Pfizer and reported in 2020, found that adding the PD-L1 antibody avelumab to curative chemoradiation for locally advanced head and neck cancer did not help, the first of several such failures. It randomised 697 patients to avelumab with chemoradiation followed by avelumab maintenance, or chemoradiation with placebo, and was stopped for futility with no improvement in progression-free survival. OnCo links it to head and neck cancer, modern external beam radiotherapy, immune checkpoint inhibitors, PD-L1 as a target and the pairing that places immunotherapy before surgery rather than with chemoradiation. Radiation-induced lymphopenia and steroid use are suspected to blunt the effect, which is why KEYNOTE-689 placed immunotherapy before surgery.
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.
697 enrolled.
Median not reached in either arm; stopped for futility at interim analysis
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | Avelumab + chemoradiotherapy, then avelumab maintenance | 350 | Median not reached in either arm; stopped for futility at interim analysis | 1.21 (0.93 to 1.57) | 0.92 (one-sided) | link |
| Placebo + chemoradiotherapy | 347 | - |
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 PD-L1, Immune checkpoint inhibitors and the tag failure.
Shares Head and neck squamous cell carcinoma and the tag failure.
Shares Immune checkpoint inhibitors and the tag failure.
Shares IMRT / IGRT (modern external beam) and the tag failure.
Shares Immune checkpoint inhibitors and the tag failure.
Shares Immune checkpoint inhibitors and the tag failure.
Shares Immune checkpoint inhibitors and the tag failure.