Genentech's Tecentriq-Avastin-Chemo Combo Dazzles in Late-Stage Study
Published: Dec 07, 2017 By Mark Terry
Genentech a Roche company, announced positive results from its Phase III clinical trial of Tecentriq (atezolizumab) and Avastin (bevacizumab) with carboplatin and paclitaxel chemotherapy in patients with previously untreated, advanced non-squamous non-small cell lung cancer (NSCLC).
Patients received Tecentriq and Avastin in addition to standard chemotherapy showed a 38 percent reduction in the risk of the disease getting worse or death compared to those who only received Avastin and chemotherapy. In addition, the 12-month landmark progression-free survival (PFS) rate doubled in the patients receiving Tecentriq and Avastin plus chemotherapy. It was a 37 percent PFS compared to 18 percent for the Avastin-chemotherapy group.
The overall response rate (ORR), or tumor shrinkage, which was a secondary endpoint, was greater in individuals with Tecentriq and Avastin plus chemotherapy compared to the Avastin-chemotherapy group, 64 percent compared to 48 percent.
“This Tecentriq study is the first positive Phase III combination trial that showed a cancer immunotherapy reduced the risk of the disease getting worse when used as an initial treatment in a broad group of people with advanced non-squamous NSCLC,” said Sandra Horning, Genentech’s chief medical officer and head of Global Product Development, in a statement. “The IMpower150 study represents an important advance in lung cancer treatment, and we will submit these results to regulatory authorities around the world to potentially bring a new standard of care to people living with this disease as soon as possible.”
There have been some concerns over safety issues with oncology combination cocktails, but the company indicates that the safety profile for Tecentriq and Avastin and chemotherapy was consistent with their individual safety profiles, and no new safety signals were observed.
It was only two days ago that the U.S. Food and Drug Administration (FDA) approved Genentech’s Avastin for adults with glioblastoma that progressed after prior therapy. It had already received provisional approval under the FDA’s accelerated approval program.
That decision was based on EORTC 26101, an independent Phase III trial conducted by the European Organization for Research and Treatment of Cancer (EORTC). It looked at adding Avastin to Iomustine chemotherapy in 432 patients with previously treated glioblastoma.
Horning said in a statement, “Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat. Delaying disease progression and reducing the need for corticosteroids over the course of treatment are considered important goals for those impacted by this devastating disease where patients have limited treatment options.”
The shift to full approval was based on a complete analysis of evidence of the drug in glioblastoma, which included the EORTC 26101 trial. In the EORTC trial, the drug did not meet the primary endpoint, which was overall survival and progression-free survival. It did increase the time to disease program or death compared to chemotherapy alone. To date, Avastin has been approved in the U.S. for nine uses across six different types of cancer.
Avastin is an intravenous biologic antibody that binds to vascular endothelial growth factor (VEGF), which has a key role in the lifecycle of the tumor in growing and maintaining blood vessels. The drug interferes with the tumors’ blood supply.
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein. By inhibiting PD-L1, Tecentriq is believed to allow T cells to be reactivated.