NIVOPOSTOP (GORTEC 2018-01)
NIVOPOSTOP showed that adding the immunotherapy nivolumab to chemoradiation after surgery for high-risk head and neck cancer kept about one in ten more patients free of relapse at three years, the first improvement in post-operative treatment in two decades.
Overview
NIVOPOSTOP randomised 680 patients whose head and neck squamous cell carcinoma had been removed but showed high-risk features, extranodal extension or positive margins, to standard postoperative cisplatin chemoradiation with or without nivolumab given before, during and after it. Postoperative chemoradiation had been the standard since the Bernier and Cooper trials of 2004, and no drug had improved on it since.
Presented at the ASCO plenary session in June 2025 by Jean Bourhis for the French GORTEC group, the trial met its primary endpoint: three-year disease-free survival was 63.1 percent with nivolumab against 52.5 percent without (hazard ratio 0.76). Most patients were HPV-negative smokers with oral cavity, laryngeal or hypopharyngeal tumours, the group with the most to gain. Toxicity was as expected for a PD-1 antibody added to chemoradiation.
Together with KEYNOTE-689, which placed pembrolizumab before and after surgery, it brought immunotherapy into curative-intent treatment of head and neck cancer after several concurrent chemoradiation trials had failed, and it suggests that timing, around rather than during radiotherapy, is what matters.
- 63.1 vs 52.5 out of 100 alive without the cancer coming back at 3 years with Nivolumab + postoperative chemoradiation compared with Postoperative chemoradiation; 10.6 more per 100.
- Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 24 percent lower chance of the event at any given time (hazard ratio 0.76).
- 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: Resected locally advanced head and neck squamous cell carcinoma at high risk of relapse (extranodal extension or positive margins): nivolumab before and during postoperative cisplatin chemoradiation, then nivolumab alone, versus chemoradiation alone. 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.
680 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 3 yearsprimary | Nivolumab + postoperative chemoradiation | - | 63.1% | 0.76 | - | - |
| Postoperative chemoradiation | - | 52.5% |
Similar pages
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