Adjuvant Opdivo Combo Improves Survival Outcomes in Advanced Head and Neck Cancer

Among patients who are at high risk of relapse with locally advanced squamous cell carcinoma of the head and neck, adjuvant Opdivo (nivolumab) with cisplatin and radiotherapy significantly improved disease-free survival compared with other treatments, according to data from the phase 3 NIVOPOSTOP trial which were shared in a presentation at the 2025 ASCO Annual Meeting.

At the data cutoff of April 30, 2024, 252 disease-free survival events were recorded. The median follow-up was 30.3 months. The 3-year disease-free survival rate was 63.1% in the Opdivo arm and 52.5% for patients in the standard of care arm, which was cisplatin plus radiotherapy.

Of note, the 12-month disease-free survival rate was 71.7% versus 64.7%, and the 24-month rates were 64.9% versus 56.2% in the Opdivo and standard of care arms, respectively.

The cumulative incidence of loco-regional relapse at 1 year was 11% versus 16%, at 2 years it was 12% versus 19%, and at 3 years it was 13% versus 20% between the Opdivo and standard of care arms, respectively.

“Post-operative Opdivo added to standard of care cisplatin-[radiotherapy] improved patient outcomes for resected high-risk locally advanced squamous cell carcinoma of the head and neck, that could be proposed as a new standard treatment,” Dr. Jean Bourhis, professor and chief of radiation oncology at the Lausanne University Hospital in Lausanne, Switzerland; medical director of GORTEC; and principal investigator of the study, said during the presentation.

The trial enrolled 680 patients and randomly assigned them to either the Opdivo group (332 patients) or the standard of care group (334 patients). Patients were given one dose of Opdivo at 240 milligrams (mg), followed by 360 mg of Opdivo every three weeks for three doses plus 100 mg/m2 of cisplatin every three weeks and immune-modulated radiotherapy at 66 Gy, followed by 480 mg of Opdivo every four weeks for six doses. The standard of care arm was given 100 mg/m2 of cisplatin every three weeks and immune-modulated radiotherapy at 66 Gy.

Patients were included in the trial if they were younger than 75, had an ECOG performance status of 0 or 1, and had SCC of the oral cavity, oropharynx, or hypopharynx with: complete macroscopic surgical resection, stage 3 or 4, or high-risk pathological features of relapse.

The median patient age was 59 in both arms, 75% and 77% of patients were male, 51% and 50% had an ECOG performance score of 0, 54% and 48% were current smokers, and 58% versus 58% had the main tumor site in the oral cavity between the Opdivo and standard of care arms, respectively.

Investigators also looked at whether Opdivo compromised the compliance with standard of care cisplatin. Overall, 301 patients in the Opdivo arm and 304 in the standard of care arm received cisplatin, with 82% of the Opdivo arm getting the cumulative dose of 200 mg/m2 or more compared with 87% in the standard of care arm, and 62% versus 68% received cisplatin for three cycles. Receipt of radiotherapy was also analyzed with 303 patients in the Opdivo arm and 306 in the standard of care arm, with 95% of patients receiving radiotherapy for 55 days or less compared with 97%, and 91% versus 95% were given a dose of 66 Gy.

Of note, 310 patients were given Opdivo before or during radiotherapy, with 75% receiving it for 4 cycles. Additionally, 260 patients were started on Opdivo maintenance with a median number of 6 maintenance cycles. The median number of total Opdivo cycles was 10.

Grade 1/2 treatment-emergent side effects noted in either the Opdivo or standard of care arms included stomatitis (58% versus 58%), radiation skin injury (59% versus 63%), dysphagia (32% versus 33%), nausea (40% versus 45%), and dry mouth (38% versus 42%). Grade 3 (server) or 4 (life threatening) treatment-emergent side effects included stomatitis (25% versus 24%), dysphagia (24% versus 18%), neutropenia (23% versus 23%), renal disorder (11% versus 5%), and radiation skin injury (7% versus 7%).

Reference

Bourhis J, Auperin A, Borel C, et al. NIVOPOSTOP (GORTEC 2018-01): 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. J Clin Oncol. 2025;43(suppl 17):LBA2. doi:10.1200/JCO.2025.43.17_suppl.LBA2

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