Positive Results Announced for Lung Cancer Drug

Genentech recently announced positive phase 3 results for Tecentriq (atezolizumab) in patients with lung cancer.

The study, OAK, met its co-primary endpoints and found that Tecentriq improved overall survival compared with docetaxel chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer, whose cancer progressed on or after platinum-based chemotherapy, according to a press release.

The co-primary endpoints were improved overall survival in patients randomized to treatment in the study and in a group of patients whose tumors expressed PD-L1 group. Researchers measured PD-L1 expression in tumor cells (TC) and tumor-infiltrating cells (IC) through an experimental immunohistochemistry test based on the SP142 antibody.

Tumors that had PD-L1 expression showed an immunohistochemistry score of TC1/2/3 or IC1/2/3, according to Genentech. Secondary endpoints were: objective response rate, progression-free survival, duration of response, and safety.

There were 1225 patients included in OAK randomized to receive an intravenous infusion of either docetaxel or Tecentriq every 3 weeks. The primary efficacy analysis was based on 850 patients, and the secondary analysis will include all patients, they reported.

No new adverse events were experienced by patients during the study. Previously known serious events are:

• pneumonitis
• hepatitis
• colitis
• hormone gland problems
• neuropathy
• meningoencephalitis
• inflammation of the eyes
• severe infections
• severe infusion reactions

More common side effects include tiredness, decreased appetite, nausea, urinary tract infection, fever, and constipation, according to Genentech. Currently, there are eight phase 3 clinical studies evaluating Tecentriq monotherapy or combination therapy in patients with lung cancer.

The drug was already granted Breakthrough Therapy Designation by the FDA for the treatment of patients with PD-L1 positive non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy.

Tecentriq already received FDA-approval for the treatment of locally advanced or metastatic urotherlial carcinoma that progressed during or after treatment with platinum-based chemotherapy, or worsened within 1 year of platinum-based chemotherapy prior to, or after, surgery, according to 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,” said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech “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.”