Nivolumab May Enhance Outcomes with SOC Therapy for Locally Advanced HNSCC

Douglas R. Adkins, MD, professor and medical oncologist in the John T. Milliken Department of Medicine of Washington University in St. Louis, MO, suggested that results from the phase 3 NIVOPOSTOP/GORTEC 2018-01 trial (NCT03576417)may impact standard of care (SOC) treatment in patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in Europe, where the trial was conducted, and abroad.¹ The trial evaluated the addition of adjuvant nivolumab (Opdivo) to cisplatin and radiotherapy in this patient group.

In a discussion with CancerNetwork®, Adkins discussed which presentations he was looking forward to seeing at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.¹ He highlighted these sessions in the context of a conversation on results from the phase 3 KEYNOTE-689 (NCT03765918) trial assessing the addition of neoadjuvant and adjuvant pembrolizumab (Keytruda) to SOC treatment in this patient population, which he presented at ASCO.²

Adkins identified the presentation on the phase 3 NIVOPOSTOP trial as one of the sessions he was looking forward to, given that it, like KEYNOTE-689, was evaluating PD-1 inhibition in patients with locally advanced HNSCC. Furthermore, he explained that the topline report in a press release on the trial favored the use of immunotherapy given after surgery-based treatment, suggesting a potential impact on SOC treatment for this patient group.³

Transcript

In the context of locally advanced head and neck cancer, the trial called the NIVOPOSTOP trial [was] one of the plenary sessions at [ASCO 2025]. This is a trial conducted in Europe, and in contrast to the KEYNOTE-689 trial, in which pembrolizumab was given before and after surgery-based treatment for patients with locally advanced head and neck cancer, NIVOPOSTOP enrolled patients who [previously received] surgery and then received adjuvant radiation-based treatment, either with or without nivolumab.

Both pembrolizumab and nivolumab are a type of immunotherapy drug that inhibit the PD-1 receptor and have the opportunity to enhance the immune response [that reduce] the chance of recurrence. The topline report in the press release stated that outcomes were better in the NIVOPOSTOP trial with nivolumab given after surgery-based treatment.³

I am looking forward to seeing these results, and I am excited to see how they may also impact the [SOC] treatment, particularly in Europe, where the trial was conducted.

References

1. 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
2. Adkins D, Haddad RI, Tao Y, et al. Neoadjuvant and adjuvant pembrolizumab plus standard of care (SOC) in resectable locally advanced head and neck squamous cell carcinoma (LA HNSCC): exploratory efficacy analyses of the phase 3 KEYNOTE-689 study. J Clin Oncol. 2025;43(suppl 16):6012. doi:10.1200/JCO.2025.43.16_suppl.6012
3. GORTEC announces new trial success for head and neck cancer treatment. News release. GORTEC. January 7, 2025. Accessed June 5, 2025. https://tinyurl.com/5n8wuez7