The IO Clinical Trial Gap in the Black Patient Population: It’s Time to Sound the Alarm

In 2017, I was diagnosed with stage four triple-negative breast cancer (TNBC), one of the most aggressive forms of the disease. My body was riddled with tumors in my lungs, pelvis, ribs, and spine. I was given a four percent chance of survival. What would be my saving grace, and would it involve clinical research?

According to a CRI-sponsored retrospective study published in November 2022 in Nature Reviews Drugs Discovery, between January 2010 and August 2022, the FDA approved 92 immuno-oncology (IO) drugs. Out of the 113 pivotal trials that led to these approvals (involving close to 60,000 patients) Black patients represented just an astounding two percent of the participants in the trials.

When you look at the overall picture of what that two percent really means, I’d equate it to an enormous wave of missed opportunities. According to a 2022 report from the American Cancer Society regarding mortality for African Americans diagnosed with cancer, the disease is the second leading cause of death behind heart disease, and an estimated 36,430 Black men and 37,250 Black women were expected to die from cancer.

As a patient and advocate who identifies as African American, I can understand how the lack of participation in my community regarding clinical trials has come about. The answer does not come neatly packaged, or easy to unwrap or digest. The answer comes from a multitude of aspects, some of which I experienced, and others I’ve heard from while consulting with other patients on their cancer journey.

So, let’s look at my case, which is one of the most fascinating stories of self-advocacy, resiliency, and science you’ll ever hear. My story addresses many of the harrowing hurdles African American patients face on a day-to-day basis to stay alive.

Nobody can really prepare you for a cancer diagnosis. It can be an isolating and difficult journey. Although I did my best to prepare, the news of a stage four diagnosis was one of the most indescribable moments of my life. I went through a roller coaster of emotions, some dark, some sad, but mostly hopeful and curious as to how I was going to get myself out of an unsure future and extend my life.

The thought of trying to keep my emotions in check and make an informed, science-based decision about my treatment weighed heavily on my mind. Who should I talk to? What drugs were being developed? Had anyone like me from my community had this experience and survived? What did I need to know about my disease and how do I get the information?

My journey to stay alive and obtain access to innovative, next-generation treatments that could extend and possibly save my life was by all accounts amazing but daunting. My work as an advocate is based on this eye-opening experience. Not only was I faced with medical bias (from my unwilling original oncologist) but I also had to tackle the hard concrete barriers of health literacy, access to tools (like those wonderful scientific biomarkers) economics (the cost of such care), skepticism, and isolation.

The idea to join a potentially lifesaving clinical trial arose from my tenacity to gather information. I was like a detective, treating my advanced disease as if it were a crime, an assault on my body. I spent numerous hours scouring the Internet, reading reports, white papers, and interviews trying to find doctors who were doing research specifically for late-stage triple-negative breast cancer.

Luckily, I came across an article that led me to an oncologist who had a strong history of clinical research. I remember having to be brutally honest and transparent with my ask to her office manager. You see, I had undergone a CT scan that indicated there “were several areas of activity” but I did not have a formal diagnosis of stage four when I contacted this research oncologist. My persistence paid off and I was scheduled for a consultation just a few days after initial contact. It would be a life-changing visit.

I’d never had contact with a research oncologist before, and had no idea what to expect, but the visit was a game changer. The advice I was given is something that altered the trajectory of my cancer journey. I was introduced to the ideas of immunotherapy, tumor mutational burden score, and genomic testing. The doctor listened patiently as I discussed my impending feelings of distress about a possible late-stage disease diagnosis, and my resolve to make an informed decision about my medical care instead of an emotional one.

The research oncologist shared that, if I wanted to make an informed decision, then it would have to be science-based. I would need access to next-generation sequencing for my tumor. The research oncologist believed that next-generation sequencing (or genomic testing) should be the standard of care for anyone diagnosed with late-stage disease. In addition, I should also undergo a biomarker test measuring tumor mutational burden or TMB. The TMB score is a tool that oncologists use to see if a patient might be a good candidate for treatment with immunotherapy.

Using my newfound education, I started to do research on immunotherapy and how it was used to treat cancer. Now you must remember this was 2017 and at the time there was no FDA approval for the treatment of TNBC other than

chemotherapy. I’d had my share of chemotherapy when I underwent standard-of-care treatment for my cancer when I was diagnosed at stage one in 2015. No one had ever discussed with me a maintenance drug (which some diagnosed with early-stage aggressive TNBC are given), immunotherapy as a treatment option, or a clinical trial.

It was important for me to compartmentalize my search and I broke it down into sections. My goal was to get as much information as a could from researchers familiar with the use of immunotherapy, patients who had participated in an IO trial, and clinics that were running these clinical trials. My work was cut out for me, and time was ticking.

I came across stories of patients like Stephanie Joho, and K.T. Jones who had experiences with immunotherapy and were sharing their stories. This was all new territory for me and I was so grateful that someone could give me some insight. I had no patient navigator, no intervention or tutorial, and no plan to follow but my own. I learned as I went along. It came down to all old-fashioned grit, follow through, and long hours of dedication to become a self-educated advocate.

I took all this newfound information back to my original oncology team. In between conducting my own research, I had undergone a biopsy of the spine. I received the heart-breaking news on my return visit to my original oncologist, a confirmed diagnosis of stage four triple negative breast cancer. The news was grim – I had a four percent chance of surviving.

With grace, steely determination, and focus I asked my original oncologist for access to the tools that would help me make a science-based decision about my care. What I received instead was a hard slap of medical bias. Thank goodness I had the wherewithal to record the conversation. I was denied access to genomic testing, sidetracked when bringing up the option of immunotherapy as a treatment, and was told, “We should exhaust all standard conventional care, and if that does not work, then we can think about the things that you are bringing up.”

Instead of hope and options, my original oncologist was handing me a shovel to dig my own grave. It wasn’t until I pushed back and the original oncologist asked, “Who have you been talking to,” that my words become valuable. I revealed that I had obtained second, third, and fourth medical opinions. Immediately my original oncologist wanted to know what was said. To make a long story short, I informed that oncologist that in order to make an informed decision and to base my treatment options on science I was going to have to undergo some testing that she had just denied. I asked for a printout of my medical records and walked out of that office, divorcing my oncologist on the spot. Ultimately, it was a lifesaving decision.

Fast forward several weeks later, after receiving a copy of my genomic report and TMB score. Although the reports gave me clarity on my tumors’ metabolic makeup and confirmed that I would be a good candidate for an IO-based clinical trial, I was faced with the job of finding an immunotherapy trial.

The hurdles and barriers continued. For weeks in the spring of 2017, I was faced with the reality of trying to find the right trial. I was very specific and methodical in my search. The parameters for me were:

1. IO-only based trial
2. A duo and not a single agent-based trial (also known as monotherapy)
3. A Phase 1 only (I did not have the time to be randomized as I needed the drugs)
4. A trial that I could get to easily (at least on the East Coast)
5. The trial had to be conducted at a teaching institution with experienced researchers.

In the end, I was able to find a research oncologist who knew of a clinical trial that I would be perfect for. I became the first patient in the nation diagnosed with late-stage TNBC to be entered into this trial. The trial was not solely focused on treating TNBC and I was okay with that, because of access to the biomarker testing which indicated that IO-based therapy was the way to go. The clinical trial had all the attributes I was looking for and more. Not only did I have a new oncology team, but I also was going to be treated at a quality facility in my community that was dedicated to making sure that I could sustain participating in the trial.

Just twelve weeks after my metastatic breast cancer diagnosis, I went from a team that did not care and offered no options to a team that displayed professionalism and care. I had a principal investigator, a clinical research nurse, a phlebotomist, an infusion nurse, social worker, nutritionist, masseuse, insurance rep, and librarian. In addition, there was coverage for my meals, valet parking, and costs for participating in the trial. I had a team behind me that was working like a well-oiled machine to make participating in the clinical trial smooth. This was a huge benefit.

Just eight weeks after entering the immunotherapy clinical trial, I took my first CT scan, which indicated that I had a 72 percent reduction in my lesions. As time moved on the scans improved and my body began to heal itself, thanks to the immunotherapy. I’ve been in remission and off drugs since 2019. I am what is known as a complete responder.

Today as a patient advocate, I often encourage African American patients diagnosed with late-stage disease to seek a second opinion and find a doctor who will value your voice, listen to you, and provide education and options. In addition, I have open conversations with researchers, biotech, and big pharma about initiatives to bridge the clinical trial gap in African American communities and improve health literacy when it comes to precision oncology and IO-based treatment therapies. I’ve heard from patients that have indicated that providers have not offered an immunotherapy plan based on cost (before even asking the patient if economics was an issue) or did not offer biomarker testing.

It pains me to know that in addition to those social determinants of health in the African American community, patients are faced with an uphill battle of health literacy, accessible treatment options, lack of diversity and investment in the workforce (how many of us everyday patients can count on one hand the number of Black clinical research oncologists) and trial site cultural competency.

Despite the grim statistics, encouraging signs are on the horizon. We are in a time where a tremendous amount of funding, effort, and education is being infused into equity and inclusion in the African American community regarding clinical trials.

Teaching institutions have reported back to share their plans to build curricula and modules that will specifically address the lack of diversity in clinical trials for the underserved Black and Brown communities. Nonprofits and advocates are working in collaboration with big pharma to improve diversity and representation on clinical trial steering committees, and strides are being taken to bring legislation to address these issues and build best practices to Congress.

About the Author

Karen Peterson is the founder and chief patient advocate of Karen’s Club, after her very own medical journey inspired her to help other patients of color understand the complex and sometimes skeptically-viewed world of clinical trials. A six-year, stage 4 triple-negative breast cancer survivor, her life was saved via a Phase 1 immunotherapy-only clinical study.

Karen is a founding member of the Patient Community Council at Foundation Medicine, a consultant for Blue Note Therapeutics as well as a Cancer Research Institute ImmunoAdvocate. Karen was the featured patient speaker at the Biden Cancer Initiative’s 2019 presentation at ASCO, and one of eight patient stories nationally to be featured in the 2020 Inaugural AACR Cancer Disparities Progress Report presented to Congress. Additionally, in 2022 Karen was honored to accept an invitation to join the National Medical Association’s Project Impact 2.0 Advisory Panel. Her inspiring story has been shared with Cure, Essence, Health, and People magazines as well as ABC Radio Networks “Perspective” and The Today Show. 

Karen successfully completed the exclusive 2021 Robin Hood/Blue Ridge Lab Fellowship, where she co-created the advocacy platform Karen’s Club, which educates, informs, and supports patients of color around clinical trials. Karen’s Club builds trust, credibility, and health literacy by providing free 1:1 consultations with patients and families. Lastly, in January 2023, Karen’s Club was awarded a grant in partnership with NYC’s Mt. Sinai Hospital to provide intervention and Phase I clinical research literacy to patients diagnosed with cancer.

Photo credit: Sacred Moon Photography