Genentech’s pivotal Phase II study of Atezolizumab meets end points

The open-label, multicenter, single-arm Phase II study BIRCH observed that atezolizumab shrank tumors in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expressed Programmed Death Ligand-1 (PD-L1).

Atezolizumab is an investigational monoclonal antibody designed to interfere with a protein called PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells.

BIRCH evaluated the safety and efficacy of atezolizumab in 667 people with locally advanced or metastatic NSCLC whose disease expressed PD-L1.

During the trial, patients received a 1,200mg intravenous dose of atezolizumab every three weeks.

The study showed the amount of PD-L1 expressed by a person’s cancer correlated with their response to the medicine.

Roche Global Product Development head and chief medical officer Dr Sandra Horning said: "We plan to present results at an upcoming medical meeting and will discuss these data as well as results from our other lung cancer studies with health authorities to bring this medicine to patients as quickly as possible."

Secondary endpoints included duration of response (DoR), overall survival (OS), progression-free survival (PFS) and safety.

Earlier this year, 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.

According to the American Cancer Society, it is estimated that more than 221,000 Americans will be diagnosed with lung cancer in 2015, and NSCLC accounts for 85% of all lung cancers.

It is estimated that approximately 60% of lung cancer diagnoses in the US are made when the disease is in the advanced stages.

Currently, there are 11 ongoing or planned Phase III studies of atezolizumab across certain kinds of lung, kidney, breast and bladder cancer.