Dive Brief:
- In clinical trials, atezolizumab shrank PD-L1-positive, refractory lung cancer tumors.
- Atezolizumab is a monocolonal antibody that is designed to bind to PD-L1, one of the key mediators for immune suppression.
- Currently, Roche has 11 phase III trials for using atezolizumab to treat various types of cancer.
Dive Insight:
Last year, Roche received breakthrough therapy designation for atezolizumab. That status has allowed the company to receive more intensive guidance from the FDA, including the involvement of more senior agency personnel and a rolling review of its New Drug Application (NDA).
In addition to positive mid-stage results for atezolizumab in lung cancer, in July Roche reported atezolizumab shrank tumors in patients with advanced or metastatic urothelial bladder cancer. In addition, Roche is also testing atezolizumab as part of combination therapy with another immunotherapy drug (from Amgen) for treatment of triple-negative breast cancer and colorectal cancer with liver metastases.
One of the most interesting findings during clinical trials has been that tumor responsiveness is largely correlated with the amount of PD-L1 that is expressed on the tumor.