Genentech, a member of the Roche Group focused on cancer immunotherapy and personalized medicine, recently announced interim results of a Phase II study (POPLAR) assessing the investigational cancer immunotherapy MPDL3280A (anti-PDL1) in patients with non-small cell lung cancer (NSCLC). The results will be presented in the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago from May 29 – June 2, 2015. The presentation is entitled “Efficacy, safety and predictive biomarker results from a randomized Phase II study comparing MPDL3280A vs docetaxel in 2L/3L NSCLC (POPLAR)” (Abstract #8010, Sunday, May 31, 4:42-4:54 P.M.).
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85% of all lung cancers. MPDL3280A is an investigational immunotherapy against NSCLC, which corresponds to an engineered anti-PDL1 (programmed death-ligand 1) monoclonal antibody able to interfere with PDL1, a protein expressed on tumor cells and tumor-infiltrating immune cells that is thought to play a major role in suppressing the body’s immune system. By inhibiting PDL1, MPDL3280A may be able to activate immune T cells, restoring their ability to effectively recognize and attack tumor cells.
MPDL3280A is currently under investigation in several clinical trials, including the multi-center, randomized Phase II POPLAR study (NCT01903993). In this study, 287 patients with previously treated, advanced or metastatic NSCLC were enrolled and stratified according to their PDL1 expression on tumor-infiltrating immune cells. The trial’s primary endpoint is overall survival, while the secondary endpoints include safety, overall response rate and progression-free survival. MPDL3280A treatment was compared to docetaxel, a well-established chemotherapeutic drug.
The POPLAR trial showed that MPDL3280A is able to double the likelihood of survival in patients who expressed the highest levels of PD-L1 in comparison to docetaxel chemotherapy. In fact, MPDL3280A improved the overall survival in patients with any degree of PD-L1 expression and was found to be well tolerated by the patients. The team believes that PD-L1 expression could be used as a biomarker for a good response to MPDL3280A treatment.
“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 Genentech’s Global Product Development and Chief Medical Officer Dr. Sandra Horning in the press release. “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 has received a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with PDL1-positive NSCLC, whose cancer has progressed during or after standard treatment. This designation intends to accelerate the development and review of drugs for serious diseases and helps ensure patients have access to them as soon as possible. Genentech is currently discussing the POPLAR trial results with the FDA.