Therapy Showing Promise in Phase 3 Study in Advanced Non-Small Cell Lung Cancer

Therapy Showing Promise in Phase 3 Study in Advanced Non-Small Cell Lung Cancer

Patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on platinum-based chemotherapy show significant improvement in overall survival when treated with the anti-PD-L1 immunotherapy Tecentriq (atezolizumab), compared Taxotere (docetaxel) treatment, according to the results of a Phase 3 clinical trial recently announced by Genentech.

“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,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, 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.”

A key factor in cancer development is the ability of cancer cells to evade the body’s immune defenses. They do so by expressing specific ligands at the cell surface, such as PD-L1, that binds to the PD-1 receptor at the surface of immune cells, hindering the immune system’s ability to recognize and kill the cancer cells. By inhibiting this pathway, Tecentriq is able to induce a stronger immune response against cancer cells.

Tecentriq is received approval by the U.S. Food and Drug Administration (FDA) to treat patients with locally advanced or metastatic urothelial carcinoma, a common type of bladder cancer. It is currently being assessed in patients with early and advanced stages of lung cancer in eight Phase 3 studies, either alone or in combination with other treatments.

The OAK Phase 3 trial (NCT02008227) is a global, multicenter, open-label, and randomized study designed to evaluate the safety and efficacy of Tecentriq versus Taxotere in patients with locally advanced or metastatic NSCLC whose disease progressed on or after treatment with platinum-based chemotherapy.

The study enrolled 1,225 patients who were randomized to receive an intravenous infusion of either Tecentriq (1200 mg) or Taxotere (75 mg/m2) every three weeks. Those in the Tecentriq arm continued receiving treatment until clinical benefit was no longer observed or until unacceptable toxicity. Patients were categorized based on the expression of PD-L1 either on the tumor cells or on tumor-infiltrating cells.

Its primary endpoints were overall survival in all patients and in a selected PD-L1 selected subgroup. Secondary endpoints included objective response rate (ORR), duration of response, progression-free survival, and safety.

In the primary efficacy analysis, based on the first 850 randomized patients, the study met its primary endpoints, showing a statistically significant and clinically meaningful improvement in overall survival, compared to Taxotere chemotherapy. Genentech plans to present the study’s full results at an upcoming medical meeting.

Tecentriq was designated a Breakthrough Therapy by FDA to treat patients with PD-L1 positive NSCLC whose disease progressed on or after platinum-based chemotherapy, and its Biologics Licence Application for NSCLC was granted Priority Review. A decision is expected on or about Oct. 19.