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Q&A with Ronan J. Kelly: FDA Approval of Immunotherapy Drug Nivolumab

A major advancement for cancer patients has happened today, stemming from clinical research that was conducted right here in Dallas. What do patients need to know about the significance of the FDA’s approval of nivolumab? 

Today, the FDA approved nivolumab, an immunotherapy drug that was shown in a clinical trial to double disease-free survival in patients with early stage tumors. This is a major step – one that we believe is the start of a new era of cancer care.

This is important for our patients, as it is moving immunotherapy drugs beyond treatment for metastatic, advanced cancers and into treatment for early stage, operable tumors.

For example, before this trial, patients with early stage esophageal cancers were treated with chemotherapy, radiation and surgery (trimodality therapy). As a result of the CheckMate 577 trial and today’s FDA approval, we now have a new treatment option: patients with early stage esophageal cancers still get trimodality therapy, but now we add immunotherapy after they've recovered from their surgery. This phase III global study which enrolled 794 patients across 29 countries and 174 study sites showed that we can double the disease-free survival when nivolumab is used as an adjuvant therapy in the post-operative setting. This is why we say it really signifies the start of a whole new era in cancer care, where patients with early stage operable tumors, who may be at risk of recurrence, can get an immunotherapy drug to prevent the tumor from coming back.

How does the immunotherapy drug work?

Just as we're all now getting vaccinated to “turn on” our immune system against the COVID-19 virus, what the FDA approved today is an immunotherapy drug that can help the body’s immune system in the fight against early stage cancers.

Nivolumab is a medication, called a PD-1 inhibitor, and these drugs are designed to prevent the cancer from hiding from your immune system. So far, seven of these drugs have been approved for use across a wide range of metastatic cancers and it is now standard of care for patients with inoperable advanced malignancies to receive a PD-1 inhibitor.

What we haven't had – with the exception of melanoma – is the use of these drugs in earlier-stage disease. That changed with today’s FDA approval. 

The CheckMate 577 study proved we can give these drugs to prevent a patient’s tumor from hiding from immune cells. Here’s how: Typically, when immune cells are close to a tumor, the tumor tries to defend itself by utilizing a certain protein called PD-1 to prevent a patient’s own immune system from attacking the cancer cells. These drugs, called PD-1 inhibitors, prevent the tumor from doing that. And so immune cells can now start attacking tumors, and we're seeing amazing advances – for the first time – in patients with early stage, operable cancers to prevent the cancer from coming back. This study specifically looked at those with esophageal and gastroesophageal junction cancers.

I anticipate many more advances in the future utilizing immunotherapy drugs in early stage cancers to prevent disease recurrence. This should provide our patients considerable hope for a brighter future, and it provides treating oncologists more tools for the fight.

Tell us more about the study that led to today’s FDA approval. How many patients participated, what did the study involve?

This trial was sponsored by Bristol Myers Squibb, and it enrolled patients from 170 centers across 29 countries. Looking at the geographical breakdown, 32% of the patients were from the US and Canada, 38% were from Europe, 13% from Asia and then just over 16% were from other parts of the World. There were 794 patients enrolled in this study, and it was designed so that 532 patients got treatment after their surgery with the immunotherapy drug, and 262 got placebo, which was the standard of care, as close observation following surgery for esophageal and gastroesophageal junction cancers is what oncologists have been trained to do up to this point.

It took us approximately five to six years to do this study from the initial concept all the way through to treating the last patient.

The credit goes to the sponsor of the study and to this brave group of patients who were willing to try something new after such a major operation. The treatment was very well tolerated and, once they recovered from their surgery, anywhere from about 10 weeks or so, patients felt much better. We gave patients the treatment for a year and the result was remarkable: the immunotherapy drug, nivolumab, doubled the disease-free survival time.

Again, a lot of credit goes to the patients that participated in the study. As a result of their pioneering efforts, we've changed the standard of practice in esophageal cancer, and this is going to help millions of patients over the next couple of years.

With this trial completed and the FDA approval of the immunotherapy drug, what’s next for cancer research at Baylor Scott & White?

The Baylor Scott & White Charles A. Sammons Cancer Center here at Baylor University Medical Center is one of the top immunotherapy centers not only in Texas but also in the United States. There are a lot of advances emerging from our program – we are investigating many different immunotherapeutic strategies across a wide range of tumor types. Some of these studies are first in human, and some are only available here in Dallas.

This breakthrough today is clearly a sign that we're on the right path for giving these drugs to patients with early stage cancers, but we're also connecting all of the dots. We have a specialized laboratory here called a GMP facility, in which our team is able to take blood from a patient and identify their strongest tumor-fighting immune cells that are circulating around in their bloodstream. Then we can alter these immune cells in our GMP facility and grow them outside a patient’s body by billions prior to returning them to the patient as an infusion of a patient's own genetically altered immune cells whose mission is to overwhelm the tumor. Here at the Charles A Sammons Cancer Center we have some of the most novel cellular therapy trials in the US.

We have also recently launched a generational cancer project across Baylor Scott & White Health called the Texas Immuno-Oncology Biorepository (TIOB). In essence, we want to collaborate with our patients by treating every patient and learning from every patient.  By partnering with our patients, we offer them not only world class treatments, but we can also evaluate a patient’s immune system adapts and evolves over time, so that we can ultimately understand how to defeat cancer. We're encouraging all of our patients to learn more and participate in this long-term project.

As the largest not-for-profit health system in Texas, Baylor Scott & White is uniquely positioned to launch an aspirational project like the TIOB to learn from patients across multiple social, racial and demographic backgrounds so together we realize the dream of long term control and even cure for cancer. Together as a community we will learn how we can defeat cancer at a population level by utilizing novel diagnostic and therapeutic strategies that have not existed before.

The power to defeat cancer lies within each of us in the form our immune system. We have already shown what can be achieved by utilizing PD-1 inhibitors to turn on an individual’s own immune cells, but we are just at that start of this new era and with our patients’ help many more advances will occur over the next few years.

Ronan J. Kelly, MD, MBA, is the chief of oncology at Baylor Scott & White Health – North Texas. Dr. Kelly is the director of Baylor Scott & White Charles A. Sammons Cancer Center at Baylor University Medical Center in Dallas, and he is the W.W. Caruth Jr. Endowed Chair of Immunology at Baylor University Medical Center.

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