HNC CDKN2A Gene Abnormalities and Abemaciclib

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HNC CDKN2A Gene Abnormalities and Abemaciclib - What are they?

What is head and neck cancer?

Have you ever heard the term “head and neck cancer”? You may be familiar with this term, as it is used to describe a group of cancer types. Head and neck cancer encompasses all cancers that occur in or around the throat, larynx, nose, mouth, and sinuses. Many cases of head and neck cancers begin in the squamous cells (thin, flat cells that look like fish scales, and are found in the tissue that forms the surface of the skin, the lining of the hollow organs of the body, and the lining of the respiratory and digestive tracts) or mucus (moist tissue) surfaces of the head and neck region. These cancers are collectively referred to as squamous cell carcinomas of the head and neck.

In the United States, it is estimated that about 4% of all cancer cases are head and neck cancers. According to the Centers for Disease Control and Prevention (CDC), environment, certain types of work exposures, infections, and genetics can all influence a person’s risk of developing head and neck cancer. Regardless of how the cancer may have started, there are several treatment options available today.

Standard treatment options include:

  1. Radiation
  2. Chemotherapy
  3. Surgery
  4. Targeted therapy
  5. Immunotherapy
  6. Clinical trials

What are clinical trials?

Clinical trials offer treatment options that may not be commercially available and can prove to be beneficial. Clinical trials are research studies that test a medical, surgical, or behavioral intervention in people. They are the primary way used by researchers to find out if a new form of treatment or prevention is safe and effective. The NIH describes the 4 phases of clinical trials:

  1. Phase I: used to study the drug/treatment, determine the safety, identify side effects
  2. Phase II: the drug/treatment given to a larger group of people (100-300 participants), determine effectiveness, collect more information on safety
  3. Phase III: drug/treatment given to larger group of people (1000-3000 participants), confirm effectiveness, monitor side effects, compare with standard treatments
  4. Phase IV: after the drug/treatment is approved by the FDA, researchers track its safety in the general population

In other cases, targeted therapies may be the most effective treatment options. Targeted therapies work because they target the cancer’s specific genes, proteins, or environment that contributes to cancer cell growth and survival. To find out if targeted therapy is the best option for your tumor type, you may want to talk with your oncologist about genetic testing for your tumor to identify any genetic abnormalities. Using the genetic test results, targeted therapies can then be identified that best fit your cancer. In some head and neck cancer cases, the CDKN2A gene has an abnormality that leads to the development and growth of cancer cells.

What is a CDKN2A gene and how can the study drug abemaciclib (Verzenio) help?

If you have never heard of the CDKN2A gene before, not to worry. The cyclin dependent kinase inhibitor 2A (CDKN2A) gene provides instructions for the creation of many different types of proteins, most notably for proteins called p16 and p14. Both p16 and p14 function as tumor suppressors, meaning that they prevent cells from growing uncontrollably. When p16 binds to another protein called CDK6, it prevents the cell cycle from going forward, giving p16 control.

If the CDKN2A gene becomes mutated, it can cause many different types of cancer, including head and neck squamous cell carcinoma (HNSCC), which most often occurs in the lining of the mouth, nose, and throat. The mutation of CDKN2A is found in 23.96% of HNSCC patients, and the loss of CDKN2A is found in 9.06% of HNSCC patients. With either a mutation or a loss of this gene, there is an impact on both p16 and p14.  Without either of these proteins to regulate the cell cycle, cells can grow and divide unregulated, leading to tumor formation.

So what can you do if you have this gene abnormality and are living with head and neck cancer? You can talk to your doctor about target therapies and clinical trials. For example, the Targeted Agent and Profiling Utilization Registry (TAPUR) Study is an ongoing clinical trial with over 250 clinical sites across 28 states. It is conducted by the American Society of Clinical Oncology (ASCO), a professional organization for physicians and cancer professionals who care for people with cancer. The TAPUR Study is for people with late-stage cancer to study whether selected targeted therapies can benefit patients whose cancers do not have FDA-approved targeted therapy options and hopefully lead to increased options for personalized therapies.  

The TAPUR Study is a phase II, nonrandomized clinical trial that targets CDKN2A losses or mutations with the FDA-approved oral drug, abemaciclib (Verzenio).  In a non-randomized trial, the participants are not assigned by chance to different treatment groups. Participants may choose the group they want to participate in, or they may be assigned to groups by the researchers. In the TAPUR Study, participants are assigned to groups by the physicians participating in the trial. To learn more about common cancer terms, visit the National Institute of Health’s dictionary. Abemaciclib is a kinase inhibitor, which works by blocking abnormal proteins that signal cancer cells to multiply. By blocking these signals, abemaciclib may help to slow or stop the spread of cancer cells in the body. 

The TAPUR Study has over 250 clinical sites across 28 states in the United States. To locate a participating center near you, or for more information on the TAPUR Study, visit the TAPUR website at, where a list of open treatment arms in the study is also available. If you would like to learn more, the study team recently held a virtual live Grand Rounds which was recorded. The May 2023 TAPUR Grand Rounds recording is available for viewing and can be found under the “Study Results” page of the TAPUR website.

HNCA’s work would not be possible without our sponsors and partners. Please see below to learn more about our partners and the clinical trials that are underway to help head and neck cancer patients. For more information about clinical trials and where to find trials that might apply to you or a loved one, visit our Clinical Trial Finder or click on any of the trial opportunities below. Featured Clinical trials are meant to provide educational information about trials and not endorse any particular trial.