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A combination of two drugs – one of which is an immunotherapy agent – could become a new standard first-line treatment for patients with metastatic kidney cancer, says a researcher at the University of Toronto. 39, Dana-Farber Cancer Institute, reporting the results of a Phase III clinical trial.
Patients treated with immunotherapy avelumab plus axitinib, a targeted agent, had a significant advantage in terms of progression-free survival compared to those receiving sunitinib (Sutent), a targeted drug that was the standard treatment for renal cell carcinoma with clear cells. clear cells – – the most common form of kidney cancer.
"Patients receiving the drug combination also had a higher response rate – meaning that their tumors decreased – than the group only under sunitinib," said Toni K. Choueiri, MD, lead author and co-correspondent of the report on JAVELIN Renal 101. trial in the New England Journal of Medicine and director of the Lank Genitourinary Ankology Center in Dana-Farber.
"It's certainly better than sunitinib, and I hope it will lead to the approval of the Food and Drug Administration," said Choueiri, a professor of medicine at Jerome University and Nancy Kohlberg of Harvard Medical School.
Although combination-treatment improves progression-free survival, further follow-up is needed to show whether treatment with two drugs prolongs overall survival compared to the standard regimen.
This is the first pivotal study that badociates avelumab with a drug that targets the vascular endothelial growth factor receptor (VEGFR). VEGFR inhibitors such as sunitinib and axitinib are designed to starve tumors by disrupting the blood supply. Immunotherapy drugs such as Avelumab, which blocks an immune control point called PD-L1, act by activating "exhausted" immune T cells so that they can more effectively attack cancer cells .
The clinical trial was conducted in 886 patients with advanced and untreated renal cell carcinoma, randomized to receive the combination drug or sunitinib alone.
The results of this study showed that median progression-free survival (PFS) – the time that has elapsed before the cancer began to worsen – was 13.8 months in the group receiving treatment. And 7.2 months in patients receiving only sunitinib. These results apply specifically to patients whose cancer cells gave a positive result at the PD-L1 checkpoint blocked by avelumab. The SSP for the overall population (PD-L1 positive or negative) was similar – 13.8 months versus 8.4 months.
The proportion of patients whose tumors decreased was 55.2% with avelumab plus axitinib and 25.5% with sunitinib in PD-L1 positive patients.
"It is interesting to note that the badysis showed that all subgroups – good, intermediate and low risk patients – benefited from combined treatment," said Choueiri. This was the subject of an oral presentation that Choueiri had just given at the symposium on Genito-Urinary Cancers 2019 in San Francisco. The results were published simultaneously in the New England Journal of Medicine.
Almost all patients in both treatment groups experienced side effects. In the combined treatment group, 38.2% of patients experienced immune system-related adverse events, the most common being thyroid disorders, seen in 107 patients.
Choueiri said that for patients with advanced disease, "this is an important option.What we do in the treatment of advanced kidney cancers pushes the envelope – these treatments may not be curative, but patients are living longer and the disease is becoming more and more chronic. "
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