According to a news release from Merck, the cancer immunotherapy medicine Keytruda (pembrolizumab) was approved by the US Food and Drug Administration (FDA) on Thursday to aid in the fight against renal cell carcinoma (RCC). Keytruda is an immunotherapy drug that works with a patient’s immune system to treat advanced tumours such as lung cancer and melanoma.
The FDA approved Keytruda for adjuvant treatment in patients with RCC who are assessed to be at Intermediate-High or High risk of disease recurrence after nephrectomy, or nephrectomy and resection of metastatic lesions, according to a press statement. The approval was based on the findings of the pivotal Phase 3 KEYNOTE-564 trial, which demonstrated that Keytruda reduced the risk of disease recurrence or death by 32% when compared to placebo.
Dr. Toni K. Choueiri, the study’s principal investigator and director of the Dana-Farber Cancer Institute’s Lank Center for Genitourinary Oncology, told Fox News that doctors have been experimenting with immunotherapy as a strategy to reduce kidney cancer recurrence for decades.
“All these attempts have failed. Fortunately, we do have a drug now (pembrolizumab) which is an immune checkpoint blocker that works in such a patient population. The drug is safe and produces a 32 percent decrease in the risk of recurrence or death” According to Choueiri, who is also a Harvard Medical School professor.
Adjuvant treatment is a type of therapy used to boost the benefits of a disease’s primary treatment regimen. Adjuvant treatment choices for people with RCC are limited, according to Choueiri, and this patient population is often at risk of recurrence.
“With this FDA approval, pembrolizumab may address a critical unmet treatment need and has the potential to become a new standard of care in the adjuvant setting for appropriately selected patients,” Choueiri said in the announcement. The phase 3 trial, which included 994 patients with intermediate-high or high risk of recurrence of RCC or M1 no evidence of illness, was a randomised, double-blind, placebo-controlled experiment that looked at the use of Keytruda as adjuvant therapy (NED).
According to a research published in the New England Journal of Medicine, 496 patients were given pembrolizumab and 498 were given a placebo. Pembrolizumab therapy was found to be associated with considerably longer disease-free life than placebo, according to the study’s authors. At the 24-month follow-up, the KEYTRUDA group had a 77.3 percent disease-free survival rate compared to 68.1 percent in the placebo group.
Nick Pannone, a 62-year-old Cape Cod resident, said he was diagnosed with renal cell carcinoma three years ago and treated for prostate cancer six years ago while participating in the KEYNOTE-564 research trial. Pannone claimed he enrolled in the double-blind trial and has no idea if he received Keytruda, but “I was thrilled to be part of the research,” he told Fox News.
Dealing with cancer and participating in the study, according to Pannone, offered him hope for the future. “It does make me appreciate my life and the family and friends that surround me. I’m blessed to have a great family, friends and career” He told Fox News about it.
According to Dr. Scot Ebbinghaus, Merck Laboratories’ vice president of clinical research, “This milestone is a testament to our commitment to help more people living with cancer,” the FDA approval makes Keytruda the first new treatment approved for the adjuvant treatment of certain patients with renal cell carcinoma.