Welcome to Study of the Week from Patient Worthy. In this segment, we select a study we posted about from the previous week that we think is of particular interest or importance and go more in-depth. In this story we will talk about the details of the study and explain why it’s important, who will be impacted, and more.
If you read our short form research stories and find yourself wanting to learn more, you’ve come to the right place.
This week’s study is…
Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score
We previously published about this research in a story titled “Personalizing Treatments for Head and Neck Cancer” which can be found here. This study was first published in the scientific journal Journal of Clinical Oncology. You can view the full text of the study here.
What Happened?
Personalized medicine is a hot button term in the medical field these days, and it’s fairly self-explanatory: instead of giving every patient with a certain disease the same treatment, the approach should be customized based on the particular characteristics of the case. This can include aspects such as the genetic profile or certain biomarkers. In this study, researchers used a biomarker in head and neck cancer to determine individualized treatment approaches for patients.
A total of 882 participants were involved in the trial. These patients had their cancer tumors tested for levels of a protein called programmed death ligand-1 (PD-L1). Patients were categorized based on their PD-L1 combined positive score (CPS). 128 has a CPS of less than 1 and 373 had a CPS ranging from 1-19. The treatments evaluated in this study were pembrolizumab (and immunotherapy) plus chemotherapy and cetuximab plus chemotherapy.
The scientists analyzed the trial results and found that patients with the highest expression of PD-L1 saw the most benefit from the use of pembrolizumab alone, and could also benefit from pembrolizumab plus chemotherapy. However, patients with low expression saw very little benefit. The recommended treatment for these patients was either chemotherapy or cetuximab plus chemotherapy. Patients with moderate PD-L1 were most likely to benefit from pembrolizumab plus chemotherapy. In conclusion, the study found that testing for PD-L1 could allow doctors to personalize the treatment regimen.
About Head and Neck Cancer
The vast majority of cases of head and neck cancer are a type called squamous cell carcinoma. This type can appear on the skin and within the lining of many hollow organs, such as those of the digestive and respiratory systems. The throat, nasal cavity, and mouth are also possible locations. There are a number of risk factors for squamous cell carcinoma of the head and neck, such as tobacco, alcohol, betel nuts, gastroesophageal reflux, stem cell transplant, HPV, Epstein-Barr virus, and a diet heavy in red meat, processed meat, and eggs. Symptoms include breathing difficulties, facial swelling, a sore throat that doesn’t heal, a lump or sore that doesn’t heal, bleeding, vocal changes, and difficulty swallowing. Treatments include targeted therapies, chemotherapy, surgery, radiation therapy, and photodynamic therapy. To learn more about squamous cell carcinoma of the head and neck, click here.
Why Does it Matter?
The findings from this study promise to improve the effectiveness of treatment for people living with head and neck cancer, prolonging survival and enhancing overall outcomes. The scientists nevertheless noted some downsides of the study, such as a very limited number of participants with very low PD-L1 CPS. Additionally, the researchers cite the need for additional biomarkers that could further determine which patients could get the maximum benefit from pembrolizumab treatment.
“We have found that patients with head and neck cancer benefit from different approaches to treatment depending on the levels of a key immune protein in the tumor and among the surrounding cells. This new, more refined interpretation of the PD-L1 test should give clinicians a much clearer indication of which patients are most likely to benefit from immunotherapy alone and who should be considered for immunotherapy in combination with chemotherapy.” – Kevin Harrington, Study Leader, Professor of of Biological Cancer Therapies at The Institute of Cancer Research, London, and Consultant Clinical Oncologist at The Royal Marsden NHS Foundation Trust
These results also suggest the need for changes in regulatory approval of pembrolizumab. In the UK, for example, pembrolizumab on its own is recommended for people with moderate PD-L1 scores, when this study indicates that they would benefit more from the addition of chemotherapy alongside it.
“Smarter tests to identify patients who are most likely to respond to treatment are a key aspect of precision medicine and are urgently needed for immunotherapies. Tests like these can help improve outcomes for patients and make sure we don’t subject people who are unlikely to respond to treatments that won’t benefit them.” – Kristian Helin, Professor, chief executive of the Institute for Cancer Research
Last modified: April 17, 2023
