Drug combination could become new standard treatment for advanced kidney cancer

A combination of two drugs – including an immunotherapy agent – could become a new standard first-line treatment for patients with metastatic kidney cancer, said an investigator at the Institute of Cancer Dana-Farber, reporting the results of a Phase III clinical trial.

Patients who received Avelumab plus Axitinib immunotherapy, a targeted agent, had a significant advantage in terms of progression-free survival compared to those receiving sunitinib (Sutent), a targeted drug that was a standard treatment for renal cell carcinoma clear cell clear cells – the most common form of kidney cancer.

"Patients receiving the drug combination also had a higher response rate – that is, their tumors decreased – than the sunitinib-only group," said Toni K. Choueiri, MD, lead author and co-correspondent of the JAVELIN Renal 101 trial report in the New England Journal of Medicine and director of the Lank Genitourinary Ankology Center in Dana-Farber.

"It's certainly better than the sunitinib.I hope this will lead to the approval of the Food and Drug Administration," said Choueiri, professor of medicine at Jerome Universities and Nancy Kohlberg of the faculty. of Harvard Medicine.

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 period of time before cancer began to worsen – was 13.8 months in the group receiving the combination 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. PHC for the entire population (PD-L1 positive or negative) was similar at 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 the patients are living longer and the disease is becoming more and more chronic. " . "

Provided by
Dana-Farber Cancer Institute