Roche’s Genentech recently announced that its investigational immunotherapy doubled the likelihood of survival in lung cancer patients with the highest level of a specific biomarker.
Genentech, a member of the Roche Group, announced interim results from its mid-stage study in patients with previously treated non-small cell lung cancer (NSCLC). According to interim results from the Phase II POPLAR study, investigational MPDL3280A doubled overall survival (OS) in people whose cancer expressed the highest levels of PD-L1 (programmed death ligand-1) compared with docetaxel chemotherapy.
Additionally, the company said that a survival benefit was also observed for patients with a medium and high or any level of PD-L1 expression, as determined by an assay being developed by Roche.
“In our study of MPDL3280A in previously treated lung cancer, the amount of PD-L1 expressed by a person’s cancer correlated with improvement in survival,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “The goal of PD-L1 as a biomarker is to identify people most likely to experience improved overall survival with MPDL3280A alone, and which people may be appropriate candidates for a combination of medicines.”
The Phase II study included 287 people with previously treated, advanced NSCLC and had a primary endpoint of OS. Secondary endpoints included progression-free survival (PFS), overall response rate (ORR) and safety. The results showed that the immunotherapy reduced the risk of death by 53 percent in those with the highest levels of the biomarker, compared with those treated by chemotherapy. In the trial, MPDL3280A was generally well tolerated and adverse events were consistent with what has been previously reported for the drug in NSCLC.
The company plans on presented updated results in an oral session at the American Society of Clinical Oncology (ASCO) meeting.
In February, the investigational drug was granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA) for the treatment of people whose NSCLC expressed PD-L1 and who progressed during or after standard treatments. Genentech said that its discussing interim results from the POPLAR study with the agency, and currently has three mid-stage and six late-stage studies of MPDL3280A ongoing in several types of lung cancer.
Last updated: 5/14/15; 9:10am ET