Discussing Upcoming Data and Key Takeaways in Head and Neck Cancer

In this video, Trisha Wise-Draper, MD, PhD, discusses upcoming data eagerly awaited from the phase 3 KEYNOTE-689 (NCT03765918) and phase 3 NIVOPOSTOP (NCT03576417) trials, evaluating cancers of the head and neck and what these data could mean for the field.^1,2

In the open-label KEYNOTE-689 trial, investigators are evaluating the efficacy and safety of neoadjuvant and adjuvant pembrolizumab (Keytruda) in combination with standard-of-care (SOC) radiotherapy with or without cisplatin in treatment-naïve, high-risk, resectable, locally advanced (LA) head and neck squamous cell carcinoma (HNSCC).¹ Patients with newly diagnosed LA HNSCC are randomly assigned 1:1 to receive the experimental combination, which includes pembrolizumab 200 mg every 3 weeks for 2 cycles, then surgical resection, and then SOC plus adjuvant pembrolizumab for 15 cycles, or undergo surgical resection followed by adjuvant SOC.

In the open label, randomized, controlled, multicenter NIVOPOSTOP study, investigators are evaluating the efficacy and reduction of toxicity for nivolumab (Opdivo) in combination with SOC.² Patients with LA SCCHN, exhibiting extra capsular extension and/or high risk are randomly assigned 1:1 to receive post-operative nivolumab in combination with 3 cycles of cisplatin during radiation therapy or concomitant cisplatin with radiation therapy.

Wise-Draper, professor of medicine in the Division of Hematology/Oncology and section head of medical oncology at UC Health, Ohio, is very “excited about the neoadjuvant radiation studies.” Radiation can be very difficult especially after surgery, Wise-Draper explains and hopes that this approach will provide some relief to patients in addition to survival benefit.³

“If you are going to give [immunotherapy] in the curative setting, whether it is definitive or surgical, I would hesitate—unless you have a clinical trial—until we have a little bit more information. We are hoping American Association for Cancer Research and American Society of Clinical Oncology, will give us a little bit more data on whether it is a good idea to give immunotherapy before surgery,” Wise-Draper explains.

References

1. Ravindra Uppaluri, Lee NY, Westra WH, et al. KEYNOTE-689: phase 3 study of adjuvant and neoadjuvant pembrolizumab combined with standard of care (SOC) in patients with resectable, locally advanced head and neck squamous cell carcinoma. J of Clin Oncol. 2019;37(15_suppl):TPS6090-TPS6090. doi.org/10.1200/jco.2019.37.15_suppl.tps6090

2. A trial evaluating the addition of nivolumab to cisplatin-RT for treatment of cancers of the head and neck (NIVOPOSTOP). ClinicalTrials.gov. Updated July 5, 2024. Accessed March 27, 2025. https://clinicaltrials.gov/study/NCT03576417

3. Plavc G, Strojan P. Combining radiotherapy and immunotherapy in definitive treatment of head and neck squamous cell carcinoma: review of current clinical trials. Radiol Oncol. 2020;54(4):377-393. October 11, 2020. doi:10.2478/raon-2020-0060