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Good afternoon. My name is Dr. Ronan Kelly, from Johns Hopkins. I am the Director of the Gastroesophageal Cancer Therapeutics program. I've been asked to discuss a phase III poster, that's a trial and progress poster called CheckMate 577, which is the largest Adjuvant study of immunotherapy in patients with stage two three esophageal cancer, that's currently enrolling.
This is a global study, and it's really looking to answer a very important question. When patients are diagnosed with stage two or three gastroesophageal cancer, the standard way to treat those patients in the United States and in Europe is to give five to six weeks of chemo radiation in an effort to decrease the size of the tumor, and then a number of weeks after that, patients go for their esophagectomies.
What we know is, 25 percent of patients, when they do go for their surgery, have a pathological complete response. Unfortunately, the vast majority, 75 percent of patients, do not achieve a pathological complete response. And so when the surgeon removes their esophagus, they find from pathology examination that there were some lymph nodes that were positive, or the tumor was invading through the wall of the esophagus.
Now that disease has been removed, but what we do know is that patients who do not achieve a pathological complete response have a higher chance of disease recurrence. And unfortunately, their five year overall survival is significantly worse than compared to the 25 percent of patients who do achieve a pathological complete response.
And so, the design of this study is to see if we can involve immunotherapy after surgery in patients that get chemo radiation and then surgery. So the design of the study, it's a phase III global study. It's looking to enroll 760 patients in over 34 countries and 174 sites worldwide. This study's been open now for approximately a year, and is enrolling well. We expect that the trial should be finished by the summer of 2018.
The trial design involves patients who have stage two three gastroesophageal cancer, are diagnosed by a multi-disciplinary team who expect to give chemo radiation, and then surgery, which is the standard of care. Those patients will then be randomized after surgery in a two to one fashion, with 66 percent of patients getting the nivolumab, and 33 percent getting placebo, which is the current standard of care, in that when patients finish their surgery, we watch them very carefully, which is what happens in current practice. So this study is looking to enroll 766 patients to either nivolumab or placebo.
If this trial is positive, it will give us a new addition to how we can treat these patients, and will help answer the question of, "What do we do in patients if their tumor does not have a significant reduction after chemo radiation?" So this trial is ongoing, we start patients after their surgery, anywhere from four to 16 weeks post-surgery on nivolumab if they're randomized to the nivolumab arm. Patients get nivolumab for every two cycles for four months, and then they go to once a month for the rest of the year. So four months of ever two week visits, and then once a month visits for the rest of the 12 months. And at the end, we'll be looking at the primary endpoint of the study, which is overall survival, and we'll be looking at stratifying patients according to PD-L1 status to see if they had a better response if they were higher for PD-L1, or if they were lower for PD-L1, or if PD-L1 didn't really matter.
So that's the design of the study, hopefully we'll have some data to present in the near future, and hopefully the study will be closed within the next 12 months. Thank you very much.