The FINANCIAL — Roche on September 27 announced positive results from two phase II studies that evaluated the investigational cancer immunotherapy atezolizumab (anti-PDL1; MPDL3280A) in people with advanced non-small cell lung cancer (NSCLC).
In the randomised phase II study, POPLAR, atezolizumab met its primary endpoint and showed a statistically significant survival benefit compared to chemotherapy (HR=0.54; p=0.014) in people with recurrent NSCLC whose tumours expressed medium and high levels of PD-L1, which corresponded with people living 7.7 months longer than people who received docetaxel chemotherapy. A separate, single-arm phase II study, BIRCH, met its primary endpoint and showed that atezolizumab shrank tumours (objective response rate, ORR) in up to 27 percent (p=0.0001) of people whose disease had progressed on prior medicines and also expressed the highest levels of PD-L1. Median survival had not yet been reached. In both studies of atezolizumab, adverse events (AEs) were consistent with those observed in previous studies, according to Roche.
“Results from both of our studies in non-small cell lung cancer showed that measuring PD-L1 may help identify people most likely to respond to atezolizumab, and the majority of responses continued when these data were assessed,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “Durable responses are meaningful for people whose cancer has progressed on other medicines, and we plan to submit these results to global health authorities to bring this potential new option to people as soon as possible”.
In February 2015, atezolizumab received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of people whose NSCLC expresses PD-L1 and whose disease worsened during or after standard treatments (e.g. platinum-based chemotherapy and appropriate targeted therapy for EGFR mutation-positive or ALK-positive disease). Roche is discussing these NSCLC data from POPLAR and BIRCH with the FDA as part of its Breakthrough Therapy Designation and with other health authorities around the world. Roche currently has seven ongoing phase III studies of atezolizumab alone or in combination with other medicines for various types of lung cancer.