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

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

Adjuvant cisplatin-radiotherapy has been the standard-of-care for patients with resected LA-HNSCC 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 programmed cell death protein-1 (PD-1) inhibitors as an effective treatment for HNSCC, where they now form the standard-of-care in the recurrent and metastatic setting [2]. This finding 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 participants with resected, high-risk LA-SCCHN. Prof. Jean Bourhis (Lausanne University Hospital, Switzerland) presented the initial findings [3].

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 and safety as key secondary endpoints.

The addition of nivolumab to adjuvant chemoradiotherapy resulted in a significant improvement in DFS: 3-year DFS rates were 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,” highlighted Prof. Bourhis (see Figure). The benefit of nivolumab was consistent across subgroups, including those defined by PD-L1 status.

Figure: Disease-free survival events in participants treated with and without nivolumab on top of chemoradiotherapy [3]



CI, confidence interval; CRT, chemoradiotherapy; NIVO, nivolumab; OPC, oropharyngeal cancer;  P16, p16INK4a.

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-HNSCC, marking the first significant advance in this setting in over 2 decades.

1. Bernier J, et al. N Engl J Med. 2004;350(19):1945–1952.
2. Burtness B, et al. Lancet 2019;394(10212):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. Abstract LBA2, ASCO Annual Meeting 2025, May 30–June 3, Chicago, IL, USA.

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Posted on 30 July 2025