Genentech is planning to seek regulatory approval for a blended lung cancer treatment following positive interim results from a late-stage trial that showed a combination of Tecentriq and Avastin plus chemotherapy enabled patients to live longer.
Genentech, Inc. is planning to seek regulatory approval for a blended lung cancer treatment following positive interim results from a late-stage trial that showed a combination of Tecentriq and Avastin plus chemotherapy enabled patients to live longer.
Genentech, a Roche subsidiary, announced results of the Phase III IMpower 150 study late Sunday night. The pharma company said that early data shows the trial is on track to meet its co-primary endpoints of overall survival and showed that the combination helped people with advanced non-squamous non-small cell lung cancer (NSCLC) live significantly longer in comparison to patients who only received Avastin and chemotherapy treatments of carboplatin and paclitaxel. Genentech said the trial data showed a survival benefit “was observed across key subgroups, including those with varying levels of PD-L1 expression.”
Sandra Horning, Genentech’s chief medical officer and head of Global Product Development, said the interim results from the IMpower 150 study adds to the “growing body of evidence” that shows the combination of Tecentriq and Avastin can be an effective tool in combatting some cancers. In February Genentech announced the combination of Tecentriq and Avastin was significantly beneficial to patients with advanced or metastatic renal cell carcinoma (mRCC) who have not received prior systemic active or experimental therapy.
In December Genentech reported results from the IMpower150 study showed that the Tecentriq combination therapy reduced the risk of the worsening of disease or death by 38 percent in comparison to a combination of Avastin and chemo. This PFS benefit was observed across key subgroups, including those with varying levels of PD-L1 expression.
Horning said the company intends to submit the data to regulatory agencies to bring the lung cancer treatment to patients. Genentech is also eying another potential lung cancer approval in squamous non-small cell lung cancer. Last week Genentech reported the combination of Tecentriq with carboplatin and Abraxane from the IMpower 131 trial met its co-primary endpoint of progression-free survival (PFS) in patients with that type of lung cancer, which has proven to be difficult to treat. If the U.S. Food and Drug Administration approves the combination treatment from IMpower 150 and IMpower 131 it will certainly give Genentech a bigger slice of a market that is dominated by Merck and Bristol-Myers Squibb.
Genentech did note one shortfall in the IMpower 150 study. The company said that the interim analysis that leaving Avastin out of the equation did not help with the overall survival benefits.
“At this interim analysis, the study found that substituting Avastin with Tecentriq in the combination with carboplatin and paclitaxel did not show a statistically significant OS benefit in people with advanced NSCLC compared to a combination of Avastin plus carboplatin and paclitaxel,” Genentech said.
Genentech has eight ongoing Phase III lung cancer studies that are evaluating Tecentriq alone or in combination with other medicines. Following the positive IMpower150 and IMpower131 studies, three more Phase III lung cancer studies are expected to report this year, the company said.
According to the American Cancer Society, it is estimated that more than 234,000 Americans will be diagnosed with lung cancer in 2018, and NSCLC accounts for 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages.
