Roche's Investigational Immunotherapy Atezolizumab Shows Promise in Treating Lung Cancer

Strategic Insights -

Researchers at Roche announced that their investigational immunotherapy atezolizumab (MPDL3280A; anti-PDL1) has met its primary endpoint in a large pivotal Phase II study, known as BIRCH, demonstrating the medicine's ability to shrink tumors in people with a specific type of lung cancer. The study showed that the amount of PD-L1 expressed by a person's cancer correlated with their response to the medicine. Atezolizumab is designed to interfere with a protein called PD-L1, which can prevent the immune system from attacking cancer cells.

Key Takeaways:

  • The BIRCH study, a large pivotal Phase II study, evaluated the safety and efficacy of atezolizumab in 667 people with locally advanced or metastatic non-small cell lung cancer (NSCLC) who expressed PD-L1.
  • The study met its primary endpoint, demonstrating a objective response rate (ORR) in people with tumors expressing PD-L1.
  • The amount of PD-L1 expressed by a person's cancer correlated with their response to atezolizumab.
  • Adverse events were consistent with what has been previously observed for atezolizumab.
  • The FDA granted atezolizumab a Breakthrough Therapy Designation for the treatment of people whose NSCLC expresses PD-L1 and who progressed during or after standard treatments.
  • Roche has seven Phase III studies evaluating atezolizumab alone or in combination with other medicines as a potential new treatment for people with early and advanced stages of lung cancer.
  • Atezolizumab is designed to interfere with a protein called PD-L1, which can prevent the immune system from attacking cancer cells.
  • The goal of PD-L1 as a biomarker is to identify those people most likely to benefit when treated with atezolizumab alone, and to determine which people may benefit most from a combination of atezolizumab and another medicine.

Statistics:

  • 667 people with locally advanced or metastatic NSCLC participated in the BIRCH study.
  • 1200-milligram intravenous dose of atezolizumab was administered every 3 weeks.
  • The primary endpoint of the study was objective response rate (ORR).
  • Secondary endpoints included duration of response (DoR), overall survival (OS), progression-free survival (PFS) and safety.
  • 1.59 million people die each year as a result of lung cancer globally, which is the leading cause of cancer death worldwide.

Sources:

  • M2 PressWIRE, August 17, 2015
  • Roche website, [www.roche.com](http://www.roche.com)
  • M2 Communications, [www.m2.com](http://www.m2.com)