Date: 2014-05-31
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the 50th American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 to June 3, 2014, in Chicago
Company: Roche (Switzerland)
Product: MPDL3280A (atezolizumab)
Action
mechanism: immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. Anti-PDL1 antibody MPDL3280A is an investigational medicine designed to make cancer cells more vulnerable to the body’s immune system by interfering with a protein called PD-L1. PD-L1 is found on the surface of cells in tumours and is believed to act as a “stop sign,” preventing the immune system from destroying cancer cells. MPDL3280A is being studied in clinical trials to understand whether blocking PD-L1 will help the immune system respond to cancer. MPDL3280A is being studied in clinical trials alone and with other medicines that directly interfere with how cancer grows and spreads.
Disease: metastatic bladder cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The Phase I study is a single-arm, multi-center, open-label trial with a cohort of 68 people with previously treated, metastatic bladder cancer. The study included 30 patients who were identified as PD-L1 positive (immunohistochemistry [IHC] 2/3) using an investigational PD-L1 diagnostic test being developed by Roche.
Latest
news: * On May 31, 2014, Roche announced results from a Phase I open-label study that showed MPDL3280A (anti-PDL1) shrank tumours (overall response rate) in 43 percent (13/30) of people previously treated for metastatic urothelial bladder cancer (UBC) whose tumours were characterised as PD-L1 (Programed Death Ligand-1) positive by a test being developed by Roche.1 Adverse events (AEs) were consistent with what has been previously reported for MPDL3280A. There were no severe (Grade 4-5) treatment related AEs. The Phase I study is a single-arm, multi-center, open-label trial with a cohort of 68 people with previously treated, metastatic bladder cancer. The study included 30 patients who were identified as PD-L1 positive (immunohistochemistry [IHC] 2/3) using an investigational PD-L1 diagnostic test being developed by Roche. After six weeks of follow-up, the objective response rate (ORR) as measured by RECIST criteria was 43 percent (13/30), and after 12 weeks, ORR was 52 percent (13/25) in people with PD-L1-positive tumours. A complete response (no radiographic evidence of tumour) was observed in 7 percent of PD-L1- positive patients (2/30). The ORR was 11 percent (4/35) in people whose tumours were identified as PD-L1-negative (IHC 0/1) by our investigational test. People in the study experienced a median time to response of 42 days. Treatment-related Grade 3 AEs occurred in 4 percent (3/68) of people in the study and included weakness (asthenia; 2 percent), low platelet count (thrombocytopenia; 2 percent) and low phosphate levels (blood phosphorus decrease; 2 percent).The most common AEs observed to date occurring in more than 5 percent of patients were decreased appetite (12 percent), fatigue (12 percent), nausea (12 percent), fever (pyrexia; 9 percent) and weakness (asthenia; 7 percent). The FDA has also recently granted breakthrough designation for MPDL3280A in metastatic bladder cancer. MPDL3280A is also evaluated in a broad range of tumours, and has begun pivotal studies that include a companion diagnostic test in lung and bladder cancers.
