June 27, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Princeton, New Jersey - Bristol-Myers Squibb announced today that its drug Opdivo had been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-based chemotherapy regimen.
Bladder cancer is the ninth most commonly diagnosed cancer worldwide. There are about 430,000 new cases diagnosed each year with over 165,000 deaths annually. Urothelial carcinoma is the most common type of bladder cancer, responsible for about 90 percent of all cases. They are typically diagnosed early, but recurrence and progression is common, with about 78 percent of patients having recurrence within five years.
Patients with Stage IV bladder cancer have a five-year survival rate of 15 percent.
Opdivo has received Breakthrough Therapy Designations for a number of indications, including previously treated recurrent or metastatic squamous cell carcinoma of the head and neck, Hodgkin lymphoma after autologous stem cell transplant and brentuximab-vedotin failed, for previously treated advanced melanoma, previously treated non-squamous non-small cell lung cancer, and previously treated advanced or metastatic renal cell carcinoma.
Opdivo is one of the newest types of cancer treatments, an immuno-oncology compound. Opdivo is a PD-1 immune checkpoint inhibitor. It binds to the checkpoint receptor PD-1, which is expressed on activated T-cells, and blocks the binding of PD-L1 and PD-L2, which prevents the PD-1 pathway’s suppressive signaling on the immune system. In other words, cancer cells generate molecules that allow them to hide from the immune system. Opdivo acts by preventing cancer cells from hiding.
“Urothelial cancer is a common type of bladder cancer where patients experience high rates of recurrence and remains an area where new treatment approaches are needed, further underscoring the importance of this designation for Opdivo,” said Jean Viallet, Global Clinical Research Lead, Oncology, Bristol-Myers Squibb, in a statement. “As part of our commitment to bring Opdivo to these advanced bladder cancer patients as quickly as possible, we look forward to filing a marketing application with health authorities based on results from study -275 and other supporting data in the coming months, as well as submitting the data for presentation at an upcoming medical meeting.”
On May 11, the European Commission approved the first and only immuno-oncology combination, Opdivo and Bristol-Myers Squibb’s Yervoy. It was approved for the treatment of advanced unresectable or metastatic melanoma in adults.
“Historically, advanced melanoma has been a very difficult-to-treat disease,” said James Larking, lead author on Checkmate - 067, from The Royal Marsden, in a statement. “Now, with this approval, patients in Europe will have a treatment option combining two Immuno-Oncology therapies, Opdivo and Yervoy, which in a Phase III randomized trial has shown its ability to deliver superior efficacy versus Yervoy monotherapy in progression-free survival and response. This is truly good news for healthcare providers and the patients they treat, as it represents an important new treatment option with the potential for improved outcomes.”
Opdivo works by taking the brake off the immune system. Yervoy stimulates the immune system. In combination, it’s like simultaneously taking your foot off the brake and stomping on the gas. Although the side effects are potentially severe, the immuno-oncology combinations are showing a great deal of promise.
