A team from Roswell Park Comprehensive Cancer Center has detailed striking findings on the effectiveness of a previously untried combination of old and new drugs as treatment for recurrent ovarian cancer. Emese Zsiros, MD, PhD, FACOG, Director of Research in the Department of Gynecologic Oncology at Roswell Park, shares her team's findings that one-quarter of patients who received the combination of pembrolizumab, bevacizumab and a pill form of cyclophosphamide experienced long-term disease control along with excellent quality of life — far outpacing the effectiveness
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Roswell Park Reports Positive Outcomes from New Combination Treatment for Ovarian Cancer
So in this clinical trial, we combined three medications to treat patients with recurrent ovarian cancer. So we were very excited to find out on this clinical trial that we have great efficacy with the combination and also long term survival and excellent quality off life for our patients with ovarian cancer. My name is M S zero's. I'm a gynecologic oncologist at Roosevelt Park Comprehensive Cancer Center. So this was a face to clinical trial that we activated in 2000 and 16 at Roosevelt Park Comprehensive Cancer Center, and we allowed to enroll 40 patients who have recurrent ovarian cancer with no available treatment options left in this clinical trial. We allow patients who were platinum resistant and also some of our patients were platinum sensitive to participate During the clinical trial, they received three drug combination every three weeks, which was keep Ceuta ORP embolism, app, which was given intravenously every three weeks. They also received the vast in our bodies is a map also given every three weeks, and they took an oral pill. Cytoxan, um, every single day. The main objective word for this clinical trial was to evaluate what are the three drugs together could enhance the efficacy off keytruda, which is an immuno therapeutic drug in our cohort of patients. We understand that Keytruda, which is an approved medication for melanoma, lung cancer and multiple other cancer sites, is currently not approved for ovarian cancer patients because as a single agent medication, it has a very low response rate. It's a great medication because it's supposed to activate the immune system. However, we found that most of our ovarian cancer patients don't have sufficient immune cells in their tumor micro environment to get activated and to be able to sufficiently eliminate the cancer cells. So our rational was to use these other two drugs to enhance the efficacy, often immune. Checkpoint blockade Avastin was used to normalize the tumor vessels so our immune cells could get into the tumor tissue. And Orel Cytoxan was used to deplete some of the harmful immune cells, namely the regulatory T cells that are preventing other immune cells to recognize the cancer cells. It is clinical trial. We found that approximately half of our patients had a good response, so they achieved either complete shrinkage of their disease or partial shrinkage off their tumor. Our overall response rate was 47.5%. We also noticed that approximately 30% off our patients on this clinical trial went over one year without progressing, however several of them, even when beyond two and 2.5 years without any disease progression. This was really wonderful news to us, as most of these patients were expected toe live 3 to 6 months when they rolled in this clinical trial. Throughout the clinical trial, we also took quality off life questioners every three months to understand how our patients feel and how they function with their families. We found that that throughout the clinical trial, the majority of our patient had excellent quality off life. They continue to travel and spend good quality time with their loved ones. So in patients with recurrent ovarian cancer, when we treat them with second line chemotherapy options, we typically see a progression free survival between 5 to 6 months. So we were really excited to see a progression free survival off 10 months in this clinical trial. I also would like to highlight that approximately 30% off our patients. So one out of three patients on this clinical trial went well about one year and many off them well above two years of treatment on this triple combination. So when we examined our cohort of 40 patients have ever interested to find out who are the patients who responded the best to this triple combination? We found that patients who received less than three prior lines of chemotherapy had a much longer progression free survival than those patients who received more than three lines of prior treatment. This indicating that perhaps using immunotherapy up front rather than as a last resort would have a longer clinical benefit. We also found that patients who had BRC mutation had a little bit higher response rate. However, they did not have any difference in progression free survival than be compared it to patients who did not carry the BRCA mutation. So when we looked at whether PD a one would be a good biomarker for patients election, we found that PD a one expression did not correlate with clinical efficacy. So our next steps is to further analyze bio specimens that we collected on this clinical trial, such as tumor tissue biopsies, which most of our patients underwent tissue biopsy before and after three rounds of treatment. We also analyzing blood samples, and we also analyzing microbiome samples such a skin stool and vaginal microbiome samples to understand how old these bio specimen can help us to select. The best patient cohort for even a therapeutic treatment way also would like to understand how can be further enhance our immune system, for example, changing or diet or certain aspect of for microbiota composition. That could make people who traditionally would not respond to checkpoint inhibitor to respond to this treatment options. So the key points off this clinical trial is that the triple drug combination issued a bit of Aston. Orel Cytoxan is effective for patients with recurrent ovarian cancer, has a good response rate and also durable at least one third of our patients with excellent quality off life. So if you would like to find out more about this clinical trial and the efficacy and our patients, please contact us at Roswell Park
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