Roche’s Atezolizumab Shows Promise Against PDL1-expressing NSCLC

Roche’s Atezolizumab Shows Promise Against PDL1-expressing NSCLC

August 19, 2015

Roche’s investigational immunotherapy agent atezolizumab (MPDL3280A; anti-PDL1) achieved an objective response rate in the pivotal phase II BIRCH safety and efficacy trial, shrinking tumors among patients with programmed death ligand-1 (PDL1)-expressing non-small cell lung cancer (NSCLC).

Roche’s investigational immunotherapy agent atezolizumab (MPDL3280A; anti-PDL1) achieved an objective response rate in the pivotal phase II BIRCH safety and efficacy trial, shrinking tumors among patients with programmed death ligand-1 (PDL1)-expressing non-small cell lung cancer (NSCLC).
 
"We are encouraged by the number of people who responded to atezolizumab and maintained their response during the study, which is particularly meaningful for people who had received prior treatments," said Sandra Horning, MD, Chief Medical Officer and head of Global Products Development. Atezolizumab is an investigational engineered monoclonal antibody that targets tumor cells and tumor-infiltrating immune cells expressing PDL1 on their cell surfaces. It is believed to enable the activation of patients’ immune T cells.

Findings from the pivotal multicenter, open-label, single-arm phase II BIRCH trial showed that how much PDL1 was expressed by tumors was associated with atezolizumab response, Roche announced. Objective response rate was the trial’s primary endpoint.

The phase II trial included 667 participants with locally-advanced or metastatic PDL1-expressing NSCLC, as determined by immunohistochemistry testing. Patients were administered a 1200 mg intravenous dose of atezolizumab every 3 weeks.

Adverse events were consistent with what has previously been observed for atezolizumab, according to a company press release.1 Previously reported adverse events (AEs) associated with atezolizumab included nausea, fatigue, and constipation.

In February 2015, atezolizumab received breakthrough therapy designation from the US Food and Drug Administration (FDA) for treating PDL1-expressing NSCLC in patients whose disease had progressed during or after standard platinum-based chemotherapy and targeted therapy for EGFR mutation-positive or ALK-positive tumors.2

Roche plans to share results with the FDA and to present the new findings at an upcoming medical meeting. "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," said Dr. Horning.

Roche has seven phase III clinical trials evaluating atezolizumab monotherapy and combination therapies for early and advanced-stage lung cancer. Other phase III trials are also underway and planned to assess atezolizumab’s efficacy against some forms of kidney, breast, and bladder cancer.

References: