Janssen and Genentech are initiating two studies to determine the safety and tolerability of daratumumab (DARZALEX®) in combination with atezolizumab, an investigational monoclonal antibody.
Janssen will sponsor a Phase 1b, open-label, multi-center clinical trial that will investigate the potential of daratumumab in combination with atezolizumab in patients with solid tumors.
Genentech is the sponsor of an ongoing Phase 1b, open-label, multi-center clinical trial that will assess the following in patients with relapsed or refractory multiple myeloma:
These studies are expected to start dosing patients within a year. This is the first time that Janssen's monoclonal antibody daratumumab (that targets CD38) is being teamed up with monoclonal antibody that targets the PDL-1 protein. It is believed that the PDL-1 protein can prevent the immune system from doing it's job, so new treatments are looking for ways to block this PDL-1 protein and "take the breaks off" the immune system.
Said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen Research & Development:
"This is the first time we're exploring daratumumab in solid tumors, and we look forward to better understanding how combining these two immunotherapies may potentially benefit patients with multiple myeloma and solid tumors, who are urgently in need of new options."
In November 2015, daratumumab was approved by 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, or who are double-refractory to a PI and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
A Phase I study using atezolizumab, administered with or without lenalidomide, is currently accepting patients 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. It is sponsored by Genentech and will accept about 46 patients. There are eight active trial sites. For more information on this trial, visit SparkCures here.
about the author
Lizzy Smith was diagnosed with myeloma in 2012 at age 44. Within days, she left her job, ended her marriage, moved, and entered treatment. "To the extent I'm able, I want to prove that despite life's biggest challenges, it is possible to survive and come out stronger than ever," she says.