Immunotherapy Approvals by the FDA

I wanted to repost this list of FDA approvals of immunotherapeutics that blogger, Brad Loncar has published (***). I made a word cloud of his results and, as expected, Keytruda (pembrolizumab) and Opivid (nivolumab) had the greatest hits for therapies. In recent years the PD-1 inhibitor, Keytruda, has galvanized the immunotherapy field. Keytruda has been found to show indications in advanced non-small cell lung cancer, advanced melanoma, head and neck squamous cell carcinoma, Hodgkin lymphoma, and advanced urothelia bladder cancer. Hopefully, more malignancies can be targeted by Keytruda, along with other drugs.

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Future of Cancer Research

Anyone who works in the realm of biomedical research at one point or another has been asked this question, “When will we have a cure for cancer?” Sometimes this question can be annoying, because many people believe that cancer will be cured with one silver bullet. However, one cannot be too annoyed with the question, because it is a fairly honest question. We have been researching, reporting about, and experiencing the ups and downs of cancer for ages. After President Nixon declared war on cancer in 1971, many politicians have promised a cure for this deadly malady.  Since a large portion of biomedical research is funded through various governmental funding agencies, the people, as taxpayers, have a right to ask this question.

This blog update based on an article published by Eva Kiesler and Meredith Begley (***), which lists five reasons for continued optimism in cancer research.  Here, I will touch on three of these reasons that I find very interesting and exciting.

Precision Medicine: In 2015, President Obama announced a $215 million genetic research plan to genetically map one million people, to research the genetic causes of various cancers, and to gauge new drugs and treatments. Of course many of these ideas set forth this initiative may change under the current administration, which has not been very friendly towards science in general.  Of course there is some good mixed with the bad in the field of Precision Medicine. Some of the good can be realized in: understanding the genetic background of new diagnoses, detecting diseases at earlier stages, and developing personalized treatments. However, there are several drawbacks to this field of study that resonate with critics. The biggest criticism is what happens if all of this genetic information falls into the wrong hands. Would someone be denied insurance coverage or a job based on his/her genetic background? Time will only tell how Precision Medicine will help or hinder cancer research, especially under this new administration.

Immunotherapy: Over the past couple of years, immunotherapy has become a very “sexy” field in cancer research. Generally put, immunotherapy uses a patient’s own immune system to fight his/her cancer. It has been long believed that the “cure” for cancer lies in immunology, because cancer basically evades the surveillance mechanism of the immune system. PD-1 inhibitors represent the first class of immunotherapies, but plenty of others inhibitors are quickly catching up to PD-1 inhibitors. Recently, epacdodostat [Indoleamine 2, 3-odioxygenase (IDO) inhibitor], produced by Incyte Corporation, has had great success in combination with PD-1 inhibitors for treating non-small cell lung cancer and kidney cancer.  Many people inside and outside of the laboratory have high hopes for immunotherapy, especially through combination treatment.

Cell-based Therapies: A few years ago, chimeric antigen receptor (CAR) T cells jumped on the scene as an intriguing way to attack cancer cells. This technology makes “killer” T-cells from a patient’s own blood cells. A patient’s T cells are collected; the cells are genetically modified to attack a specific types of proteins expressed on cancer cells; and then these genetically-modified cells are re-introduced into the patient. A major concern with this technology is that one has to modify the T-cells for targets that are expressed on cancer cells and not on healthy cells. In many cases, similar proteins can be expressed on both cancer and normal cells. Since this technology is very personalized, it will take very specialized laboratories to manufacture these cells. Typically, when you get into this extreme level of specialized medicine, the price tag is not cheap. Currently, Novartis and Kite Pharma are two companies that are in the lead for getting this therapy approved by the FDA for treating acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma, respectively.

Although we have not eliminated various types of cancer, I think that we are well on our way. Here, I touched on three exciting areas of cancer research that may provide some answers in the field of oncology. I think that we are in a very exciting moment of cancer research but time will tell how effective these new therapies will be.

Minority Participation in Clinical Trials

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The other day some friends/acquaintances and I were randomly chatting about clinical trials. I say that the chat was “random,” because many of these people are not scientists and scientific topics rarely come up in these chats. Then, the story took another random twist into the area about minority groups that are involved in these trials. This twist was more comedic in nature, like would women be considered for participation in a clinical trial for prostate cancer. I wrote this entry, because I wanted to throw my thoughts and interpretations about the lack of minority enrollment in various clinical trials.

Jokes aside, why is this topic so important?

Based on statistics from the U.S. Census, the minority population was 38% of the total U.S. population in 2014; however, the minority population is expected to rise to 56% by 2060. Although minorities currently make up more than a third of the U.S. population, minorities make up less than 10% of patients enrolled in clinical trials, according to the National Institutes of Health (NIH) National Institute on Minority Health and Health Disparities. The major concern with these trials is that many illnesses are observed at a disproportionately higher rate in minority communities. Due to lower enrollment and participation, the data from these trials are limited in terms of effectiveness of treatments and may not represent the best approaches for treatment. There are several factors that may be attributed to this issue, which include lack trust of the medical community, lower incomes, less education, and greater hurdles for accessing healthcare.

In my opinion (I know that others would agree), I think distrust of the medical community and reduced access to adequate healthcare are the two most important factors affecting the enrollment of minorities in clinical trials.

Lack of trust

It is no secret that many people (in addition to minorities) has serious trust issues for towards the medical community. We are well familiar with the Tuskegee study, in which African American men with syphilis were left untreated well after it was discovered that syphilis could be cured in early stages. Although that travesty occurred in the mid 1900’s, the negative ramifications of this study (and other stores of minority medical exploitation, e.g. Henrietta Lacks) are still ingrained in the minds of African Americans. med apartheidHarriet Washington’s book “Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present” articulates the extreme nature of these notorious (and often useless) medical experiments.

Another potential reason for this distrust is due to the fact that physicians do not look like the people they are serving. Although we have made great racial strides as a country, race and racial bias are still major issues in this country. Typically, many minorities prefer to be examined by people who look like them. Perhaps, a minority patient may feel that the physician will be more empathetic to his/her medical concerns than a non-minority physician. The problem with this rationale is that minorities do not make up a large percentage of practicing physicians serving these communities. In a report from HealthDay Reporter, the percentages of African American and Hispanic practicing physicians are 4 percent and 5 percent, respectively. This statistic shows that there is a large gap between the minority U.S. population and minority physicians.

Access to healthcare

Although distrust is a major issue, I think the lack of access to healthcare is a bigger issue that must be tackled, in regards to clinical trial participation. Since many minorities live within a lower socioeconomic bracket, it is harder for these populations to visit specialists that may inform them of beneficial clinical trials. For example, many minorities have to visit lower quality community health centers where multitude of patients is a great burden for many of the physicians. In a waiting room of 50 patients, I do not think that a physician will have the time and energy to explain every potential treatment that may help one particular patient.

Since many people within these populations also live in lower-income neighborhoods, it is harder for potential clinical trial participants to even visit the health center where the studies are held. If a clinical study requires a long-term commitment with multiple checkups and site visits, this patient may not be able to enroll or complete it, because he/she cannot take time off from work, afford transportation to and from the site, or pay for extra hours of child care.  Since socioeconomic status and education level typically go hand in hand, many members of these populations may not fully understand how participation in the trials would help them and others. This hurdle especially is noticeable if the patient does not speak (or has limited knowledge of) English.

Although I have painted a somewhat grim picture, there are ways to increase the participation of minorities in clinical trials. There have been several outreach programs that will advertise these trials in churches, barbershops, language- or ethnic-specific newspapers and radio stations.  Also, the National Cancer Institute (NCI) recently funded a patient navigator program to assist in the education and enrollment of minorities in clinical trials. Specifically, these patient navigators take the burden off of primary physicians and nurses by meeting with potential trial participants, explaining the trial to the participants, and helping the participants fill out appropriate consent forms. A study in the Journal of Oncology Practice (June 2016) concluded that African American clinical trial participants were twice more like to stay in these trials when assisted with patient navigators. Even though this is a well thought out initiative, there still are issues about initially informing the patient about a potential clinical trial.

Hopefully, the medical community, through various methods of outreach, will continue its efforts in recruiting more minorities for clinical trials. Increased minority participation in these trials potentially will not only help the patient suffering from a particular illness but also provide a better overall public health.