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. 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. This trial was sponsored by Bristol Myers Squibb, and it enrolled patients from 170 centers across 29 countries. How many patients participated, what did the study involve? Tell us more about the study that led to today’s FDA approval. This should provide our patients considerable hope for a brighter future, and it provides treating oncologists more tools for the fight. I anticipate many more advances in the future utilizing immunotherapy drugs in early stage cancers to prevent disease recurrence. This study specifically looked at those with esophageal and gastroesophageal junction cancers. 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. These drugs, called PD-1 inhibitors, prevent the tumor from doing that. 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. The CheckMate 577 study proved we can give these drugs to prevent a patient’s tumor from hiding from immune cells. What we haven't had – with the exception of melanoma – is the use of these drugs in earlier-stage disease. 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. Nivolumab is a medication, called a PD-1 inhibitor, and these drugs are designed to prevent the cancer from hiding from your immune system. 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. 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. 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. 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 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.įor example, before this trial, patients with early stage esophageal cancers were treated with chemotherapy, radiation and surgery (trimodality therapy). This is a major step – one that we believe is the start of a new era of cancer care. 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. What do patients need to know about the significance of the FDA’s approval of nivolumab? A major advancement for cancer patients has happened today, stemming from clinical research that was conducted right here in Dallas.
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