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About the BAVENCIO® (avelumab) With INLYTA® (axitinib) Clinical Trial

In a clinical trial of 442 patients taking BAVENCIO with INLYTA versus 444 patients taking a medicine called sunitinib, researchers studied:

  • Progression-free survival (PFS), the length of time during and after cancer treatment that a patient lives without disease progression—meaning that the tumors did not grow or spread during this time. This is one way to check how effective a treatment is
  • Overall survival (OS), the total time patients on each medicine remained alive after starting treatment
  • Objective response rate (ORR), the percentage of patients who no longer had any signs of cancer or whose tumor shrank 30% or more and whose response to treatment lasted at least four weeks

BAVENCIO with INLYTA is not a cure. The data represent an average of patients in the clinical trial, and not all patients may experience the same results.

Together Can Be Powerful

Study Results

In a clinical trial of 442 patients taking BAVENCIO with INLYTA versus 444 patients taking a medicine called sunitinib:

BAVENCIO with INLYTA decreased the overall risk of disease progression or death by 31% compared to sunitinib (progression-free survival).

Patients taking BAVENCIO with INLYTA experienced a median PFS of 13.8 months. Median time period means that half the patients went longer than 13.8 months with no tumor growth or spread, and the other half went less than 13.8 months with no tumor growth or spread. Patients taking sunitinib experienced a median PFS of 8.4 months. That’s a 5-month increase in median PFS for patients taking BAVENCIO with INLYTA compared to patients taking sunitinib.

At the time data were collected, overall survival data were immature, which means that there was not yet enough information available to assess the impact of BAVENCIO with INLYTA compared to sunitinib on overall survival.

BAVENCIO with INLYTA reduced tumor size in twice as many patients compared to sunitinib (objective response rate).

  • 3.4% of patients (15 of 442) taking BAVENCIO with INLYTA saw their tumors disappear compared to 1.8% of patients (8 of 444) taking sunitinib (complete response)
  • 48% of patients (212 of 442) taking BAVENCIO with INLYTA saw their tumors shrink compared to 24% of patients (106 of 444) taking sunitinib (partial response)

This includes patients whose tumors shrank 30% or more and whose response to treatment lasted at least 4 weeks.

How BAVENCIO® (avelumab) and INLYTA® (axitinib) Work

BAVENCIO and INLYTA are 2 different types of medicines that work in 2 different ways.

BAVENCIO

  • BAVENCIO is an immunotherapy—a medicine that may treat advanced RCC by working with your immune system. BAVENCIO can cause your immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death
  • BAVENCIO is a man-made antibody. Your body naturally produces antibodies to help your immune system work
  • BAVENCIO may engage both your adaptive and innate immune systems
  • The immune system is a part of your body that fights diseases to keep you healthy. One job of your immune system is to remove cells that are becoming cancerous. Over time, cancer cells may be able to stop your immune system from attacking them
  • Your adaptive immune system learns to identify and adapt to threats over time, and delivers a response to defend against specific threats
  • Your innate immune system is your first line of defense against general threats

INLYTA

  • In order for cancer cells to spread, they need a constant supply of oxygen and nutrients. They get these from blood vessels
  • When a tumor reaches a certain size, it needs new blood vessels to keep growing
  • Animal and laboratory studies suggest that INLYTA prevents new blood vessels from forming
  • It is believed that this may help stop tumors from growing and cancer from spreading
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