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Generally, as humans we believe that growth is good. We grow as individuals in our bodies and minds as we age. Plants grow and reap bountiful harvests. Trees grow providing shade and areas of recluse. Unfortunately, as Americans continue to get older as a population, the growing incidence of late-stage head and neck cancer continues to rise. Much like cancerous tumours that mutate and grow, any growth of more cancer diagnoses is a trend in the wrong direction. Understanding this data and potential treatments on the horizon may help reach the goal of improved overall survival rates.

The US Census data in 2016 along with studied trends ahead of predicted 2020 numbers show one thing is for sure, America is graying. The population of 65 and older individuals in the United States is projected to nearly double in the coming decades, from nearly 50 Million in 2016 to 95 Million over 65 by 2060. This is an increase of those over 65 by nearly 15%.

Another growing trend, the rise of late-stage cases of head and neck cancer. A study published in Cancer showed the increasing rates from 2004 to 2015, led by a rising incidence among white men and the highest risk of late-stage diagnosis for black men. The United States Census Bureau currently estimates that there are nearly 44 Million Americans who identify as non-Hispanic (NH) black or African American making up over 13% of the American population.

Adam Thompson-Harvey, MD, a researched in otolaryngology and communication sciences at Medical College of Wisconsin, and colleagues hypothesized that "a priori that the incidence of late-stage head and neck cancer in the United States is increasing rather than decreasing, driven by race and sex." The team continued, "As hypothesized, we found an increasing incidence of late-stage head and neck cancer in the United States within the last decade. However, although black males still had the highest risk [for] being diagnosed with late-stage head and neck cancer, the most significant change in annual incidence patterns was driven by white males."

An Aging America

2030 marks a major demographic turning point for the United States. In that year, the final group of the Baby Boomer generation will be older than 65 and within the decade by 2034 adults aged 65 and over are predicted to outnumber children under 18 for the first time in US history.

The Medical College of Wisconsin study led by Adam Thompson-Harvey had a total of 57,118 enrolled patients with stage IV HNC (head and neck cancer diagnoses) with an average age of 61.9 years. While the researchers in the study did not limitations, including the lack of data regarding common risk factors that have been identified including HPV status, oral sex encounters and the usage of alcohol and tobacco. Despite those limitations, the team strongly believes that the results of this study contribute through the use of a well-established, long-term, population-based cancer registry that is national in scope.

As we understand that America not only is getting older, but the risk of late-stage head and neck cancer also is rising in this same group, another important element to consider is the natural immune system consequences that occur with aging.

It is now well known that the immune system weakens with age. This has been studied extensively including Causes, consequences, and reversal of immune system aging first published on March 1, 2013 by The Journal of Clinical Investigation. The effects of aging on the immune system are manifest at multiple levels including reduced production of B and T cells in bone marrow and thymus as well as diminished function of mature lymphocytes in secondary lymphoid tissues. This results in the elderly not responding to immune compromises and challenges the same way as younger individuals do.

The Medical College of Wisconsin team hoped that, "Because the diagnosis of late-stage head and neck cancer impacts survival, the results of the current study will provide targets for improving." When you combine an aging population with weaker immune systems and trending rise of cancer diagnosis, it becomes clear that something new must come.

Changing The Narrative

Currently, cancer patients upon diagnosis begin a Standard of Care that includes surgery + radiotherapy or surgery + concurrent chemoradiotherapy. As we understand the strength of the body's own immune system, as well as how it decreases over time, we can also begin to consider the opportunity to leverage our body's own internal processes to maximize life potential. CEL-SCI is a biotechnology company that is testing drugs for the treatment of cancer, autoimmune and infectious diseases through the research and development of immunotherapy products. Their team believes that harnessing the body's natural immune system and boosting that upon diagnosis can become a new kind of therapy and addition to the SOC in the fight against cancer.

Multikine, CEL-SCI's lead investigational immunotherapy, has recently completed a pivotal Phase III Clinical Trial of open-label, randomized, global study of the effects of Multike + Standard of Care in in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity and Soft Palate Versus Standard of Care Only throughout global cancer centers.

The stage at which head and neck cancer is diagnosed currently impacts the rate of survival and lifespan of the patient. With late-stage diagnosis being a higher risk in black men, having a first-line treatment like Multikine hopes to only improve the process. The immunotherapeutic agent is developed as a potential first-line neoadjuvant therapy and was tested as a treatment prior to any other therapy because that is when the immune system is strongest, before healing from surgery or radiation or chemotherapy treatments.

Multikine's Phase III Clinical Trial enrolled 928 newly diagnosed and not yet treated head and neck cancer patients with an assumed overall survival rate of about 55% at 3 years for the SOC treatment group alone. This study was the largest Phase 3 study in the world for the treatment of head and neck cancer. Currently, the data is being audited with findings expected to be reported any time in late 2020.

What's to come for Multikine, we must wait and see, but one thing is for sure. America is getting older and head and neck cancers are rising. If we want to increase our average life expectancy, we must increase the ways we diagnose and treat cancer.