Washington, DC, – The Kidney Cancer Research Alliance(KCCure) welcomes the U.S. Food and Drug Administration (FDA) decision to approve the use of Bristol-Myers Squibb’s (BMS) nivolumab (Opdivo®) and ipilimumab (Yervoy®) in combination as a front-line treatment for patients with advanced renal cell carcinoma (kidney cancer).
Ipilimumab and nivolumab are two types of immunotherapy that harness the body’s immune system to attack cancer cells. Ipilimumab is a CTLA-4 inhibitor and nivolumab is a PD-1 checkpoint inhibitor.
“Today’s decision by the FDA is a game-changer for patients and physicians managing advanced kidney cancer,” said Hans Hammers M.D., Ph.D., KCCure co-founder and senior co-author of the clinical study for the combination. “Targeted anti-VEGF therapies have dominated the front line in RCC for the last decade, but this ruling shifts the field back to immunotherapy as an opening strategy for combating the disease.”
The decision by FDA was based on the results of the CheckMate-214 trial, which looked at the combination of ipilimumab and nivolumab as compared to sunitinib in previously untreated patients with intermediate and poor risk kidney cancer, which is unfortunately the majority of patients and an area of unmet medical need.
In the combination arm 42% of patients experienced a significant shrinkage of their tumors with a 9% complete disappearance rate versus 27% and 1% on sunitinib. The median duration of response for sunitinib was 18 months but has not been reached yet for the immunotherapy arm. Importantly, the overall survival was significantly better for the immunotherapy arm with a 37% reduced chance of dying from kidney cancer. The median survival for sunitinib was 26 months but has not been reached yet for the immunotherapy arm.
“This is unprecedented and defines a new standard of care for patients with aggressive kidney cancer,” said Dr. Hammers.
“What’s exciting about this treatment is how many durable complete responses we’re seeing,” said Dena Battle, President of KCCure. “This therapy option provides new hope for patients diagnosed with metastatic kidney cancer. We’re looking forward to collaborating with others in the field to educate patients and physicians about this new first-line treatment,” said Battle.
Advances in treatment for RCC have dramatically changed the landscape for patients over the last decade and have resulted in increasing overall survival rates for the disease, which is the deadliest of all urological malignancies.
“New therapies, like the treatment approved today, would not have been possible without the brave patients who chose to enroll and participate in clinical trials,” said Dr. Hammers. “Our heartfelt thanks go to them for making this a reality for all.”
About KCCure: The Kidney Cancer Research Alliance (KCCure) is a grassroots organization of patients, caregivers, doctors and medical researchers dedicated to eliminating suffering and death due to kidney cancer through increased funding to accelerate research that will lead to a cure for all patients and prevent future kidney cancer diagnoses.
Dena Battle, is the President for KCCure. She began her career in Washington, DC, as a congressional aide, and went on to work as a lobbyist for more than 10 years, working primarily on tax and healthcare policy. After losing her husband to kidney cancer, she remained active in the patient community. In addition to leading KCCure, she serves on the NCI Renal Task Force and on the programmatic panel for the Kidney Cancer Research Program. She has testified before the FDA – Oncological Drug Advisory Board (ODAC), presented at ASCO-GU and helped co-author multiple papers on improving care for cancer patients.
Hans Hammers, M.D., Ph.D., is the Vice President of KCCure and is a nationally and internationally renowned physician and researcher in the field of kidney cancer. He serves as the Co-Leader of Clinical Research and Immunotherapy of the Kidney Cancer Program at UT Southwestern Medical Center. Dr. Hammers earned degrees from the University of Lubeck in Germany. He completed his residency training in the Johns Hopkins medical system and completed his fellowship in Medical Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital.
For more information about treatment options available for advanced kidney cancer, click here.
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