Roche announced that its investigational cancer immunotherapy MPDL3280A (anti-PDL1) shrank tumors in a Phase I open-label study.
MPDL3280A is an investigational monoclonal antibody that interferes with a protein called PD-L1. The protein is expressed on tumor cells and tumor-infiltrating tumor cells. By inhibiting PD-L1, the antibody allows for the opportunity for T cells to activate and attack tumor cells.
The investigational drug was assessed in the multi-center, single-arm, open-label Phase 1 trial involving 68 people with previously treated metastatic bladder cancer. Anti-PDL1 was able to shrink tumors in 43 percent of patients whose tumors were characterized as PD-L1. Objective response rate jumped to 52 percent in patients with PD-L1 positive tumors at 12 weeks. Furthermore, a complete response or no radiographic response of tumor was reported in 7 percent of PD-L1 positive patients.
“Bladder cancer is the ninth most common cancer worldwide, for which there have been no new treatment advances in nearly 30 years,” said Sandra Horning, chief medical officer and head of Global Product Development Roche. “We are evaluating MPDL3280A in a broad range of tumors, and have begun pivotal studies that include a companion diagnostic test in lung and bladder cancers.”
The FDA has previously awarded first Breakthrough Therapy designation to MPDL3280A as treatment for bladder cancer. The designation is intended to speed development and review of drugs that have the potential to address serious diseases and unmet medical needs.
Bladder cancer claims an estimated 145,000 deaths around the world every year. Metastatic urothelial bladder cancer is linked to poor prognosis and limited treatment options. Men are observed to be three times more likely to be affected by bladder cancer compared with women.
The company said it will present complete results of the study at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.