Tecentriq is a monoclonal antibody designed to bind to an immune checkpoint protein called programmed death-ligand 1 (PD-L1). The expression of this protein is upregulated in tumor cells, and is a strategy for tumor cells to evade the antitumor immune response.
The OAK study is a Phase 3, global, multicenter, open-label, randomized, controlled study evaluating the effectiveness and safety of Tecentriq compared to Taxotere (docetaxel, a well-established chemotherapy drug) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), in whom the disease continued to progress even in cases where patients were treated with platinum-based chemotherapy.
The study enrolled 1,225 patients who received either Taxotere (75 mg/m2 by intravenous infusion) or Tecentriq (1,200 mg by intravenous infusion) every three weeks.
Genentech reported that the study’s primary endpoints were reached. Specifically, Tecentriq was found to significantly improve the overall survival for patients with locally advanced or metastatic NSCLC.
“These results add to the growing body of evidence that supports the role of Tecentriq as a potential new treatment for specific types of advanced NSCLC,” Dr. Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release.
“This is very encouraging news for people living with this disease because lung cancer is the leading cause of cancer deaths around the world. We hope to bring this treatment option to patients as soon as possible,” she said.
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Tecentriq as a therapy for patients with PD-L1 positive NSCLC, and whenever the disease continues to progress during or after platinum-based chemotherapy. This FDA designation is also extended to patients carrying an EGFR mutation-positive or ALK-positive tumor.
Genentech, a member of the Roche group, is currently undergoing a total of eight Phase 3 lung studies evaluating Tecentriq alone or in combination with other treatments in patients with early and advanced stages of lung cancer.
Tecentriq is the only anti-PD-L1 cancer immunotherapy approved by the FDA. It is currently approved as a therapy for a type of bladder cancer called urothelial carcinoma.