Nivolumab addition sets the first new post-operative standard for head-and-neck cancer in two decades

The addition of nivolumab to adjuvant cisplatin-radiotherapy significantly improved disease-free survival (DFS) in participants with resected locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN), as shown in the phase 3 NIVOPOSTOP trial.

Adjuvant cisplatin-radiotherapy has been the standard-of-care for patients with resected LA-SCCHN and a high risk of relapse for more than 2 decades [1]. However, many patients still experience recurrence, indicating a need for improved treatment options. Recent evidence has established PD-1 inhibitors as an effective treatment for SCCHN, now forming the standard-of-care in the recurrent and metastatic setting [2].

This prompted the design of the NIVOPOSTOP study (NCT03576417), a randomised, investigator-sponsored phase 3 trial evaluating the efficacy and safety of nivolumab in combination with adjuvant cisplatin-radiotherapy in patients with resected, high-risk LA-SCCHN. A total of 680 participants were randomised 1:1 to receive a single dose of nivolumab followed by standard cisplatin-radiotherapy, and 6 subsequent doses of nivolumab, or cisplatin-radiotherapy alone (control arm). The primary endpoint was DFS, with overall survival (OS) and safety as key secondary endpoints.

Prof. Jean Bourhis (Lausanne University Hospital, Switzerland) presented the initial findings [3]. The addition of nivolumab to adjuvant radio-chemotherapy led to a significant improvement in DFS: 3-year DFS was 63.1% in the nivolumab arm versus 52.5% in the control arm (HR 0.76; 95% CI 0.60–0.98; P=0.034). “Nivolumab primarily decreased the number of loco-regional relapse events,” said Prof. Bourhis. The benefit of nivolumab was consistent across subgroups, including those defined by PD-L1 status.

Although the OS data currently favours nivolumab, longer follow-up is required to draw definitive conclusions. Nivolumab added to radio-chemotherapy resulted in a moderate increase in toxicity, without an associated rise in treatment-related deaths.

Prof. Bourhis concluded that these findings support nivolumab as a potential new standard-of-care in the adjuvant treatment of resected, high-risk LA-SCCHN, making the first significant advance in this setting in over 2 decades.

1. Bernier J, et al. N Engl J Med. 2004;350:1945-1952.
2. Burtness B, et al. Lancet. 2019;394:1915-1928.
3. Bourhis J, et al. NIVOPOSTOP: A phase III randomized trial of adjuvant nivolumab added to radio-chemotherapy in patients with resected head and neck squamous cell carcinoma at high risk of relapse. LBA2, ASCO Annual Meeting 2025, 30 May–3 June, Chicago, IL, USA.

Medical writing support was provided by Dr Marten Dooper.
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Posted on 5 June 2025