Date: 2016-03-21
Type of
information: Initiation of development program
phase: 1b
Announcement: initiation of development program
Company: Genentech, a member of Roche Group (USA - CA - Switzerland)
Product: atezolizumab (MPDL3280A) and daratumumab
Action
mechanism:
- immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. Anti-PDL1 antibody MPDL3280A is an investigational monoclonal antibody 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. By inhibiting PD-L1, MPDL3280A may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells. MPDL3280A is being studied in clinical trials to understand whether blocking PD-L1 will help the immune system respond to cancer.
- Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma. It targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells and may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD.
- In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
Disease: multiple myeloma
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This multicenter, open-label, Phase I study will evaluate the safety and pharmacokinetics of atezolizumab alone or in combination with lenalidomide in participants with multiple myeloma who have relapsed or who have undergone autologous stem cell transplantation (ASCT). The planned duration of this study is approximately 36 months (NCT02431208).
Latest
news:
- • On March 21, 2016, Genmab announced that daratumumab will be investigated in early stage clinical studies in combination with atezolizumab (anti-PD-L1 antibody), in multiple myeloma. The study will be conducted under a clinical trial collaboration agreement between Genmab's licensing partner for daratumumab, Janssen Biotech and Genentech. Genentech will amend an ongoing Phase Ib study to assess atezolizumab in combination with daratumumab, with daratumumab and lenalidomide, and with daratumumab and pomalidomide in relapsed/refractory multiple myeloma (NCT02431208). The study is expected to start enrolling patients later this year.
Is
general: Yes
