Date: 2013-05-16
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, 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 (“removing the stop sign”) 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: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On May 16, 2013, Roche has announced that the company will present important new data on its anti-PDL1 antibody MPDL3280A (also known as RG7446) at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 31 to June 4, 2013, in Chicago. Data on MPDL3280A will be presented in five oral presentations and one poster presentation: • A study of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic tumours. Abstract #3000. • Biomarkers and associations with the clinical activity of PD-L1 blockade in a MPDL3280A study. Abstract #3001. • Clinical activity, safety and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Abstract #8008. • Clinical activity, safety and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic melanoma (mM). Abstract #9010. • Clinical activity, safety and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with metastatic renal cell carcinoma (mRCC). Abstract #4505. • Clinical activity, safety, and biomarkers of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic CRC, gastric cancer (GC), SCCHN, or other tumours. Abstract #3622. Based on the results of these studies, Roche and Genentech are initiating pivotal studies investigating MPDL3280A in non-small cell lung cancer (NSCLC). These studies will incorporate an investigational companion diagnostic. Roche and Genentech are also exploring additional studies of MPDL3280A in other cancer types, alone and in combination with other medicines, including Avastin (bevacizumab) and Zelboraf (vemurafenib). Selected efficacy data to be presented at ASCO are included in the tables below. In addition to these data, updated data in other tumours (abstract #3622) will be presented. Overall Response Rates1 Overall Phase 1 experience (Abstract #3000) 21% (29/140) Metastatic Non-Small Cell Lung Cancer (Abstract #8008) 22% (9/41) Metastatic Melanoma (Abstract #9010) 29% (11/38) Renal Cell Carcinoma (Abstract #4505) 13%2 (6/47) 1) Efficacy evaluable subjects dosed prior to August 1, 2012; data cutoff February 1, 2013. 2) Renal cell carcinoma data not yet mature Overall Response Rates1 All-comers2 PD-L1 positive3 PD-L1 negative3 Overall Phase 1 experience (Abstract #3000) 21% (29/140) 36% (13/36) 13% (9/67) 1) Efficacy evaluable subjects dosed prior to August 1, 2012; data cutoff February 1, 2013. 2) All-comers includes patients with unknown PD-L1 status 3) PD-L1 status based on Roche PD-L1 IHC Among the 29 responders, 26 continued to respond at the last assessment (time on study of 3 to 15+ months). No maximum tolerated dose, dose-limiting toxicities or treatment-related deaths were observed during dose escalation. The majority of adverse events were transient Grade 1/2 events. The most common events included increased liver enzymes (AST or ALT), inflammation of the large intestine (colitis), and high blood glucose (hyperglycemia). Selected safety data to be presented at ASCO are shown below: Grade 3/4 Adverse Events Regardless of Attribution* – All Dose Cohorts (n=171) Grade 3/4 Adverse Events % (n) All Grade 3/4 Events 43% (73/171)* Hyperglycemia 5% (9/171) Fatigue 4% (7/171) Increased ALT 3% (5/171) Dyspnea 3% (5/171) Hypoxia 3% (5/171) *Adverse events regardless of whether they were assessed as being due to, disease, other factors or MPDL3280A. Data cut off Feb 1, 2013.
