June is Cancer Immunotherapy Month: we’re talking about what’s new in immunotherapy for HPV head and neck cancer patients

By Pamela Tom | HPVANDME Founder


You’ve probably heard of immunotherapy. Immunotherapy has evolved into proven treatment for a variety of cancers, including HPV-related head and neck cancers. We’re supporting June Cancer Immunotherapy Month by providing what’s new in immunotherapy for HPV head and neck cancer patients.

Who can get immunotherapy? How can you benefit from immunotherapy if you are diagnosed with head and neck squamous cell carcinoma (HNSCCA)? What are the questions that you should be asking your head and neck specialist about immunotherapy? 


What is Immunotherapy?

Immunotherapy is cancer treatment in the form of a drug or medication. It can re-awaken the body’s own immune system to fight the cancer. We asked Dr. Sara Pai, Associate Professor of Surgical Oncology at Harvard Medical School and Massachusetts General Hospital, to explain immunotherapy in simple terms.

Nine out of 10 patients diagnosed with HPV-associated head and neck cancer have an intact immune system which can fight their cancer cells,” says Dr. Pai. “However, over time, the immune system can stop working. Immunotherapy re-activates or reinvigorates the immune system to continue fighting to eliminate the cancer cells.”

One form of immunotherapy drugs works by blocking PD-1 (a protein found on activated immune cells) from binding to PD-L1. PD-L1, another protein, turns the immune cells off. If the immune cells don’t get the signal to turn off, the patient’s immune cells can continue to fight the cancer cells. 

Immunotherapy may produce side effects but arguably less severe than traditional treatments: radiation, chemotherapy and/or surgery. Even though HPV-attributable oropharyngeal cancer cases increase, doctors continue to depend on these standard treatment protocols. The problem: they were originally intended for head and neck cancers caused by smoking or alcohol use, not HPV.

That’s why researchers have been committed to developing immunotherapies that will successfully treat HPV cancer. Immunotherapies help the immune system kill the cancer cells without harsh, long lasting side effects. For example, radiation causes “dry mouth” and chemotherapy can cause extreme weight loss and weakness.


Clinical Trials Actively Recruiting

Dr. Pai is the principal investigator on two current clinical trials.

CUE-101 Trial

An ongoing clinical trial led by Dr. Pai, the study’s principal investigator, seeks to assess the safety and efficacy of an immunotherapy as a possible treatment for HPV head and neck cancer. The study involves 15 sites across the US with the hope of sampling a diverse pool of participants. 

The eligibility criteria includes newly diagnosed patients with metastatic HPV-16 positive head and neck cancer. The trial is open to both male and female adults. This is the first time the drug is being studied in human subjects. More information about this clinical trial. 

The study is showing that the “drug is safe in humans and is able to reinvigorate the patient’s immune system against the virus,” says Dr. Pai.  

What are some potential side effects from immunotherapy?

“Your immune system can become over-activated and start to attack your normal tissue such as the thyroid gland, liver, lungs, gastrointestinal tract, or skin. Because the side effects are being induced by your own body, if you were to stop the drug or give steroids to weaken the immune system, that would mitigate or help reduce the side effects,” says Dr. Pai.

Oral Decitabine and Durvalumab Trial

This Phase 1 clinical trial is studying whether combining these two drugs is safe and will boost the participant’s immune system against the cancer cells. The goal is to determine the “highest effective dose” of the drug combination and the first step in identifying another possible treatment for head and neck cancer.

For questions or to enroll, email Dr. Pai.

More clinical trials for HPV head and neck cancer patients.


What About KEYTRUDA?

A completed clinical trial found that the drug pembrolizumab, marketed as KEYTRUDA, is effective. When taken with or without chemotherapy, it helped some patients “live longer” compared to standard treatment.

“For example, patients on KEYTRUDA and chemotherapy were alive for 4.9 months without their cancer spreading, growing, or getting worse compared to 5.1 months for patients on standard treatment,” according to the pharmaceutical’s website.

“In 2019, the FDA approved pembrolizumab, with or without chemotherapy, in the first line treatment setting for patients who develop locally recurrent or distant (other parts of the body away from the tumor) metastatic disease,” says Dr. Pai.

Including KEYTRUDA in the first line treatment setting illustrates the progress and promise of immunotherapy for cancer patients. 


Immunotherapy Trends and Access

At the same time, while the use of immunotherapy treatments is growing, it is not common practice in all clinical settings. The FDA only approved KEYTRUDA for head and neck cancer treatment two years ago; then COVID hit. The key is to provide physicians more educational opportunities to learn about new immunotherapies.

Patient access remains another issue. KEYTRUDA is expensive

The American Society of Clinical Oncologists (ASCO) and the Society for Immunotherapy of Cancer (SITC) advocate for developing quality care programs for immunotherapy. Dr. Pai serves as the Chair and member of the Technical Expert Panel for the development of quality care measures as it relates to the delivery of immunotherapy. 

The group works to determine and identify the patients who are most likely to benefit from immunotherapy and enable them to get it. As researchers continue to define the optimal patient populations who may benefit from immunotherapy, the more likely the FDA will continue to approve immunotherapies and pave the way for insurance coverage of these innovative drugs.


Biomarker Test Predicts Immunotherapy Efficacy

The future is already here in the form of a PD-L1 biomarker test that’s new for head and neck cancer patients. The test is designed to predict whether patients will respond to immunotherapy or not. High levels of the biomarker indicate that a patient is most likely to respond to immunotherapy; low or no biomarkers means the patient is less likely to respond and should follow chemotherapy treatment instead.

“HPV is a prognostic biomarker. It tells us whether a patient is going to do well or not, but there is no standard of care therapy that is tailored to the HPV positive head and neck cancer patient,” says Dr. Pai.Here, we have a biomarker which is relevant to both HPV positive and negative patients and which can let the patient know whether s/he is likely to respond to treatment.”

Patients may ask their doctors to perform PD-L1 biomarker testing on their tumors. Samples may be taken from archival tissue when a patient was first diagnosed, or the doctor may obtain a fresh sample.

If you have immunotherapy news to report, please write to us: info@hpvandme.org