Genentech will present the most recent results on their ongoing developments for non-small cell lung cancer (NSCLC) at this years’ Annual Meeting of the American Society of Clinical Oncology (ASCO).
The results are from a global, randomized Phase II study (POPLAR) where 287 non-small cell lung cancer (NSCLC) patients who previously underwent docetaxel chemotherapy were treated with Genentech’s investigational immunotherapy drug MPDL3280A (anti-PDL1).
The study presented by Dr. Alexander I. Spira, Virginia Cancer Specialists Research Institute, U.S. Oncology Research, set as its primary endpoint the assessment of patients’ overall survival, with secondary endpoints including progression-free survival (PFS), overall response rate (ORR) and safety.
The POPLAR study showed patients with non-small cell lung cancer (NSCLC) expressing the highest levels of protein PD-L1 (programmed death ligand-1) and previously administered with docetaxel chemotherapy, when treated with MPDL3280A (anti-PDL1) doubled their likelihood of overall survival when compared to controls (patients with docetaxel chemotherapy alone). The benefits of MPDL3280A (anti-PDL1) were extended to patients exhibiting lower to medium levels of PDL1. In general, MPDL3280A (anti-PDL1) was well tolerated.
Sandra Horning, M.D., chief medical officer and head of Global Product Development commented, “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. 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.”
MPDL3280A (anti-PDL1, also known as RG7446) is an investigational monoclonal antibody targeting the PD-L1 protein in both tumor cells and tumor-infiltrating immune cells. The antibody prevents PD-L1 to bind its receptors, PD-1 and B7 in T cells promoting their activation and allowing T cells to identify and attack tumor cells more efficiently. As MPDL3280A showed substantial improvement over existing therapies, the U.S. Food and Drug Administration (FDA) awarded MPDL3280A in February 2015 with a Breakthrough Therapy Designation in order to expedite the development of medicines focused on treating serious diseases and assuring patients’ prompt access to them through FDA approval. Accordingly, Genentech has ongoing Phase II and Phase III studies for the role of MPDL3280A in several types of lung cancer.