The Challenges of Research in Immunotherapy

Cancer research has made great advancements in recent years with emerging treatments like immunotherapy. Harnessing the immune system in different ways to better combat cancer has proven effective for a variety of cancer types, including mesothelioma. But there is still a lot of work ahead to truly understand how the treatment can be most effective.

While this progress with immunotherapy has given patients a lot of hope, it hasn’t been an easy road and there are still many obstacles to face before the treatment reaches its full potential. Researchers have already faced many barriers with clinical trials and the cost of this treatment, and there will likely only be more challenges ahead.

In observance of Cancer Immunotherapy Month, we spoke with medical professionals working in different specialties to get their take on immunotherapy. In the first article of this series, we asked them about the potential for immunotherapy and recent exciting developments. In this article, we learned what barriers they’ve come up against and potential future obstacles for the emerging treatment.

Availability of Immunotherapy

In many cases, patients can only receive immunotherapies through clinical trials because the treatment is still so new. Researching a new drug or type of treatment takes years, and the process goes through different phases of testing. It can be a delicate balance of finding the right clinical trial at the right time during its different phases of research.

There are thousands of clinical trials going on at any given time, and it can be difficult to understand all the nuances of choosing and joining a clinical trial. It’s understandably an overwhelming decision to choose a clinical trial to pursue from a list of possibly hundreds a patient may be eligible for. Even with advice from an oncologist and lots of research, patients may be taking a gamble on choosing one promising clinical trial over another.

Research shows, however, that many patients don’t even consider such a decision. The majority of cancer patients choose not to participate in a clinical trial and stick with standard treatment methods instead.

“There are so many clinical trials that need to be done to get us to the next steps. Clinical trials are, for the most part, the best therapy available to patients,” explained Dr. Ezra Cohen, the director of translational science at UC San Diego. “The sobering reality is that only 3% of adult cancer patients participate in clinical trials. We need to urgently break down barriers to participation and encourage patients to seek out clinical trials.”

For those that do choose to participate, there are no guarantees. Different phases of clinical trials take on varying numbers of participants, which ultimately puts some patients on a waiting list to see if they can have their chance at a promising new treatment. And even if the patients are able to join and begin the trial, there are never any guarantees the treatment will work for them or what kind of side effects they may experience.

But despite the risks involved, researchers hope patients take the time to learn about clinical trials they may be eligible for and take a leap of faith. “I encourage all eligible patients to consider clinical trials, especially when immunotherapy agents are involved, because it is through these trials that we develop the science and improve patient outcomes,” insisted Dr. Bradley Corr, assistant professor in gynecologic oncology at the University of Colorado.

Cost of Immunotherapy Drugs

“The research is still expensive but I believe more critical now than ever. We are at a time when the technology, biology, and drug development have come together in a way that will change the field forever. We must take advantage of that,” said Dr. Cohen.

Cancer treatment costs in general have grown exponentially over the years with no sign of lowering any time soon. The cost of making a cancer drug and going through these trials can be well over a billion dollars, and unfortunately leads to patients also taking on a high expense to receive the treatment.

Keytruda® (pembrolizumab) for instance has shown promise for mesothelioma and other cancers, but the cost of the drug can be well beyond many patients’ means. Recent estimates say Keytruda costs about $13,000 every month, which would add up to $156,000 for one year of treatment.

“Once you get to the third, fourth or ninth treatment, you have incurred a lot of treatment cost, and if you don’t have coverage what do you do?” said Dr. Satish Shah, an oncologist and hematologist at Gettysburg Cancer Center. “How can you not have treatment that is potentially life saving? [But] if one treatment is $10,000, how can you justify that treatment?”

Since these drugs are often part of clinical trials, much of these costs will be covered by the sponsor of the study. However, that doesn’t mean the participants won’t have any costs of their own. Any additional testing or procedures required as a result of the trial often aren’t covered by insurance, though in some cases the sponsor will also cover these additional expenses.

But even with coverage, health insurance is often not enough when dealing with cancer, and it’s estimated patients on average pay at least 20 – 30% of cancer drugs costs out of their own pockets. Many cancer treatments and clinical trials span well beyond a single calendar year, meaning patients often end up with a lifetime of debt to receive lifesaving treatment.

Whether participating in a clinical trial or turning to more conventional treatments, patients face a hefty price tag. Chemotherapy, for example, costs a few thousand dollars for a single treatment, so one round of chemo can reach upwards of $50,000.

Though there are some options to alleviate the financial burden of cancer treatment, the price of these drugs can often cause patients to avoid the potential benefits of a more costly emerging treatment.

Understanding the Side Effects

Since immunotherapies are still in the early developmental stages, researchers still have a lot to learn. As with any developing treatment, there are still many unknowns and more questions will likely continue to emerge as research continues.

“I think the biggest barrier presently is our need to understand the immune system further and execute the experiments that move the field forward,” said Dr. Cohen.

The immune system is extremely complex, and will take time for researchers to fully understand how it reacts with these new treatments, as well as how cancer reacts with our immune system. One main focus of research currently is determining why immunotherapy has worked so well in certain types of cancers, but not in others, which researchers believe is because of the immune environment. Researchers also question the side effects patients may encounter.

“This particular type of treatment is very different so one challenge would be familiarity with the administration of these drugs to understanding the side effects and appropriately because some of these side effects could be permanent damage,” Dr. Shah explained. “So you have to be knowing as a health care provider, and you as a patient, what changes have occurred and be careful what you report to your doctor so your doctor is aware of what to look for.”

Immunotherapies have been found to cause a wide range of side effects, such as skin reactions or flu-like symptoms. In general, researchers have said these therapies are pretty well tolerated, but there are a lot of unknowns in terms of how immunotherapy might affect the body over a long period of time or years after treatment.

Regardless of the obstacles and risks, immunotherapy is an exciting new treatment that has the potential to change cancer care for good. With continued research and support, it will likely only become more effective for more cancers, and maybe even help lead to a cure.