11 December 2018 - - The US Food and Drug Administration approved Tecentriq (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations, US-based Genentech said.

Genentech is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY),

This approval is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer compared to Avastin and chemotherapy (median overall survival [OS] = 19.2 versus 14.7 months; hazard ratio [HR] = 0.78; 95% CI: 0.64-0.96; p=0.016) in the intention-to-treat wild-type (ITT-WT) population.

The safety profile of the Tecentriq combination was consistent with that observed in previous studies.

Genentech is working with the FDA on postmarketing commitments to better understand and characterize the potential effects of Tecentriq-related anti-drug antibodies and neutralizing antibodies across all of our studies.

An analysis of ADAs in the IMpower150 study showed no impact on the efficacy of Tecentriq.

Tecentriq is also approved by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK genetic alterations.

For those who qualify, Genentech offers patient assistance programs for people taking Tecentriq through Genentech Access Solutions.

IMpower150 is a multicenter, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and paclitaxel) with or without Avastin in people with Stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease.

It enrolled 1,202 people, of whom 1,045 were in the ITT-WT subpopulation, which excluded those people with EGFR and ALK mutations.

Access Solutions is part of Genentech's commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay.

The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine.

To date, the team has helped more than 1.5m patients access the medicines they need.

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Avastin is a prescription-only medicine that is a solution for intravenous infusion.

It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis.

Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).

Founded more than 40 years ago, Genentech is a biotechnology company that discovers, develops, manufactures and commercialises medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.