Genentech recently announced positive results from the pivotal Phase 3 OAK study (NCT02008227) demonstrating that its cancer immunotherapy Tecentriq (atezolizumab) is more effective than the chemotherapy Taxotere for increasing patients’ median overall survival.
The findings were presented at the European Society of Medical Oncology (ESMO) 2016 Annual Meeting Oct. 7-11 in Copenhagen.
Tecentriq is a monoclonal antibody designed to bind to an immune checkpoint protein called programmed death-ligand 1 (PD-L1), which is increased in cancer cells and allows tumor cells to evade immune system responses. By blocking PD-L1 action, Tecentriq halts the tumor strategy and lets the immune system respond by activating crucial immune cells called T-cells.
The results showed that patients with non-small cell lung cancer (NSCLC) treated with Tencentriq can live an average of 4.2 months longer than those treated with Taxotere.
The OAK study enrolled 1,225 NSCLC patients who experienced cancer progression even after one or more treatments of platinum-based chemotherapies in second-line and third-line treatments. Patients with squamous and non-squamous disease types were included regardless of their PD-L1 status. Adverse side effects were consistent with those observed in previous Tecentriq studies.
“Tecentriq is the first and only anti-PD-L1 cancer immunotherapy to help people with metastatic NSCLC live significantly longer than chemotherapy regardless of their PD-L1 expression level or their disease histology,” Dr. Sandra Horning, Genentech’s chief medical officer and head of global product development, said in a press release. “Even people whose disease had low or no observed PD-L1 expression still showed a significant benefit from the medicine.”
The U.S. Food and Drug Administration (FDA) had previously granted Breakthrough Therapy Designation for Tecentriq to treat people with PD-L1-positive NSCLC whose disease has progressed during or after platinum-based chemotherapy.
Genentech’s Biologics License Application (BLA) for NSCLC was granted FDA priority review with an action date of Oct. 19, 2016.