Saby George, MD, FACP, and Dena Battle, president of nonprofit patient advocacy group, KCCure, discussapproval of Opdivo (nivolumab) and Yervoy (ipilimumab) therpay combination for kidney cancer.
In a recent interview, Rare Disease Report ® spoke with Saby George, MD, FACP, associate professor of oncology at Roswell Park Comprehensive Cancer Center, specializing in the treatment of kidney, bladder, and prostate cancers and an investigator on Opdivo (nivolumab) and Yervoy (ipilimumab) clinical trials and Dena Battle, president of nonprofit patient advocacy group, KCCure, to discuss the recent FDA approval of Opdivo (nivolumab) and Yervoy (ipilimumab) therapy combination for the treatment of kidney cancer.
Rare Disease Report® (RDR®): What is this new combination therapy for kidney cancer that was recently approved?
George: I am one of the clinical investigators at the Roswell Park Comprehensive Cancer Center Institute and I focus on the treatment of kidney cancer. I do clinical trials with amino oncology drugs, and I’m a big consultant for Bristol Myer Squibb (BMS).
This new combination is Opdivo (nivolumab) and Yervoy (ipilimumab), which was tested against sunitinib in a large trial named CheckMate 214. This trial demonstrated that patients who were treated with the Opdivo and Yervoy combination can produce higher rates of tumor shrinkage and [help] people live longer compared [with] sunitinib.
This is an amino oncology drug, which basically activates the immune system, which goes and fights the cancer.
RDR®: How does this therapy impact patients with this rare disease?
Dr George: Kidney cancer affects 63,000 patients and nearly results in 14,000 to 15,000 deaths a year in the United States; it is a very fatal disease. This is a breakthrough development, which [helps] these patients live longer, meaning death is delayed or they are doing really well.
The study also demonstrated that the combination immunotherapy could also produce nearly a 9% complete response rate. That means that 9% of the patients treated with the combination could go into complete remission.
This combination was tested since late 2014-early 2015 through last year and is still ongoing. It took nearly 3 years for the study to report and based on the report that came in the New England Journal of Medicine a month ago, the FDA approved this combination nearly 3 to 4 weeks ago. It is available for patients through oncologists in the region. This is a big breakthrough in kidney cancer research because of its wonderful results.
RDR®: Dena, as a patient advocate, you launched KCCure to increase research funding for this disease. How do you feel about this new drug approval?
Battle: KCCure is a grassroots organization of patients and doctors that came together to increase awareness for this disease, and we are ecstatic about this new combination therapy. To have something new like this available to patients is extremely exciting. The results were fantastic, and it just adds to the arsenal that patients have against kidney cancer, which is still the deadliest urological malignancy out there.
RDR®: Do you personally know any patients who are going to be really excited for this drug? How much do you think this will impact the community?
Battle: I think it’s going to have a huge impact. As I said, it’s [kidney cancer, which is] still the deadliest urological malignancy out there. Unfortunately, I lost my husband to kidney cancer, which is one of the reasons I have stayed active in the advocacy community. I know for so many patients and their family members, it’s easy to lose hope when you’re dealing with this diagnosis and you see some of the really grim statistics.
This is a new treatment that offers patients the hope of what we call a complete response—it’s the closest thing you can come to for a cure for this disease. We really want to encourage patients to seek out educational material, [in hopes that] they can share [the materials] with doctors [and] they can know this treatment is available.
I should add that we are very grateful to industry partners like Bristol Myer Squibb that have helped us produce some of that material that is in our website.
RDR®: To echo you, this combination is as close to a cure as you could hope for?
Battle: There are a number of treatments out there that are available, but we did see really high complete response rates in the trial, so it’s something that patients can look to and be excited about.
RDR®: What message would you like to get out to patients with kidney cancer?
George: Once again, this is a wonderful breakthrough, and the patients who are affected by kidney cancer should go talk to their oncologists and seek out clinical trials. The beauty of clinical trials is that I was able to offer the research drugs to patients 3 to 4 years before those drugs get approved (if it’s a positive study). That means we’re helping a lot of patients with future drugs. I encourage patients to consider clinical trial enrollment as well as going to specialized centers for their care for kidney cancer.
Battle: I just remind folks to seek out information about their diagnosis and their disease. Our website and also opdivo.com is a great resource for patients to learn more about this combination therapy that is available now.
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