The JAVELIN Renal 101 clinical trial is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma. Pfizer and Merck are the collaborative sponsors. The trial involved 886 patients at 283 research site locations including Dana-Farber Cancer Institute. The trial involves the combination of two drugs – one of them an immunotherapy agent – which could become a new standard, first-line treatment for patients with metastatic kidney cancer, says an investigator from Dana-Farber Cancer Institute, reporting results from the phase 3 JAVELIN Renal 101clinical trial. Dana-Farber recently published a news release in EurekAlert! highlighting observations.
Patients who received the immunotherapy drug avelumab plus axitinib, a targeted agent, had a significant advantage in progression-free survival compared with those who received sunitinib (Sutent), a targeted drug that has been a standard treatment for advanced clear cell renal cell carcinoma – the most common form of kidney cancer. While progression-free survival was improved with the combination treatment, additional follow-up is needed to show whether the two-drug therapy extends overall survival compared to the standard regimen. The trial is the first pivotal study to combine avelumab with a drug that targets the vascular endothelial growth factor receptor (VEGFR). VEGFR blockers like sunitinib and axitinib are designed to starve tumors by disrupting their blood supply. Immunotherapy drugs such as avelumab – which blocks an immune checkpoint called PD-L1 – work by activating “exhausted” immune T cells so they can more effectively attack cancer cells.
The results from this study showed that the median progression-free survival (PFS) – the length of time before the cancer began to worsen – was 13.8 months in the combination group and 7.2 months in patients receiving only sunitinib. These results specifically applied to patients whose cancer cells tested positive for the PD-L1 checkpoint that is blocked by avelumab. The PFS for the overall population (PD-L1 positive or negative) was similar – 13.8 months versus 8.4 months.
Follow the link below for the entire Dana-Farber press announcement.