January 16, 2023

ASCO Releases New Guidelines for Immunotherapy and Biomarker Testing in Recurrent and Metastatic Head and Neck Cancers

Recommendations focus on selecting the right biomarkers for the right setting

Head and neck cancers

An estimated 66,470 people in the U.S. were diagnosed with head and neck squamous cell carcinoma (HNSCC) last year. These encompass a diverse and complex set of diseases that often are diagnosed at an advanced stage. Many HNSCC treatments can significantly impact a patient’s quality of life, causing issues with speech, taste, swallowing, lymphatic processes and more, making it all the more crucial to hone in on the right targeted therapy from the start. Clinicians often struggle with determining the optimal frontline treatment and choosing between immunotherapy and more systemic therapies in recurrent metastatic disease.


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With the emergence of immune-checkpoint inhibitors for use frontline treatment of head and neck cancers, biomarkers such as programmed death ligand-1 (PD-L1) and tumor mutation burden are increasingly important for treatment selection. To that end, ASCO convened a panel of medical, surgical and radiation oncologists as well as radiology, pathology and patient advocacy experts to create a single source of information for treating recurrent disease in different types of head and neck cancers. A patient representative also played a significant role in developing the recommendations, ensuring that the guidelines were practical and that the language was accessible to patients.

“We wanted to provide clearer guidelines to clinicians and patients for all range of head and neck cancers, including less common cancers such as nasopharyngeal carcinomas and salivary gland tumors,” says Emrullah Yilmaz, MD, PhD, expert panel co-chair and a hematologist/oncologist with Cleveland Clinic’s Taussig Cancer Institute. “Particularly for rare cancers, where there are not large sets of trial data, it can be tough to know which treatment approach to use.”

To produce the guidelines, the panel conducted an extensive review of 28 relevant phase 3 trials published between 2000-2022 to discern outcomes of interest, such as survival and overall response to treatment. “The most important takeaways from the new ASCO guidelines are to check the patient’s PD-L1 to help with the decision about whether to use a single agent or combination immunotherapy, with or without chemotherapy,” says Yilmaz.


Notable updates to the ASCO guidelines include the following recommendations:

  • Conduct PD-L1 immunohistochemistry testing for patients with recurrent or metastatic HNSCC.
  • Interpret PD-L1 combined positive score ≥ 1 as positive, which correlates with a clinical benefit of PD-1 inhibitors.
  • Consider tumor mutation burden testing for patients with recurrent or metastatic disease when CPS is not available the PD-L1 combined positive score is not available or in patients with rare tumors.
  • A tumor mutation burden of ≥ 10 should be interpreted as high, which correlates with a clinical benefit of PD-1 inhibitors.
  • Offer pembrolizumab monotherapy or pembrolizumab, platinum and fluorouracil as first-line treatment for patients with recurrent or metastatic HNSCC with a combined positive score of ≥ 1.
  • Consider pembrolizumab, platinum and fluorouracil as first-line treatment for patients with recurrent or metastatic HNSCC with a combined positive score of < 1.
  • Pembrolizumab or nivolumab should be offered to patients with platinum-refractory recurrent or metastatic HNSCC, regardless of CPS status.
  • Toripalimab, camrelizumab or tislelizumab, with gemcitabine and cisplatin, should be offered as first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer.

The panel hopes that guidance for more specific treatments will result in higher success rates for patients. Dr. Yilmaz noted that there is more work to be done to continue to develop appropriate therapies. “Participation in ongoing clinical trials will help to further improve outcomes. There is much effort being undertaken by the National Cancer Institute to design trials that are easier for patients to participate in.”

Learn more in our recent podcast.


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