Genentech, Inc., a Roche Group company, indicated its IMpower131 Phase III clinical trial of Tecentriq (atezolizumab) with carboplatin and Abraxane met its co-primary endpoint of progression-free survival (PFS) in lung cancer. Although a statistically significant overall survival (OS) benefit wasn’t seen and the study will continue, these results gives Genentech a lead for potentially becoming first-line treatment for squamous non-small cell lung cancer (NSCLC).
Although specific data was not released, the company said that it met its co-primary endpoint of PFS, cutting the risk of the disease growing worse or death compared to the group receiving chemotherapy alone. Safety was consistent with the individual medicines and no new safety problems were observed.
IMpower131 is a Phase III, open-label, multicenter, randomized trial to study the efficacy and safety of Tecentriq with carboplatin and nab-paclitaxel, or Tecentriq in combination with carboplatin and paclitaxel versus carboplatin and nab-paclitaxel alone in patients with stage IV squamous NSCLC who haven’t been previously treated with chemotherapy. The study involves 1,021 people.
The American Cancer Society estimates that 234,000 people in the U.S. will be diagnosed with lung cancer this year, and NSCLC accounts for 85 percent of all lung cancers.
"Squamous non-small cell lung cancer is difficult to treat and there have been limited new treatment options over the last few decades," said Sandra Horning, Genentech’s chief medical officer and head of Global Product Development, in a statement. "We will share the IMpower131 results with global health authorities and we look forward to seeing more mature overall survival data."
Jefferies published a note today, suggesting Tecentriq’s potential blockbuster status. "IMpower131 is an important study for Roche," it noted. "Squamous cell NSCLC, which accounts for about 25 to 30 percent of NSCLC, is a more complicated disease than non-squamous NSCLC and there are fewer treatment options. Roche has previously noted that it could be first to market in the 1L (first-line) squamous NSCLC setting if IMpower131 produced a superior result. We currently model $1.1 billion of peak sales for Tecentriq in this 1L squamous setting and have previously highlighted that a positive result from the trial could see 1 to 3 percent upside to EPS and valuation."
The lung cancer market is a competitive one, with Merck & Company and Bristol-Myers Squibb Company dominating, but Roche could elbow them aside, particularly if further study of Tecentriq shows improved overall survival. IMpower 131 is one of five Phase III readouts that Roche and Genentech have planned this year in lung cancer, with another three gathering data in clinical trials.
In its fourth-quarter financial reporting, Daniel O’Day, chief executive officer of Roche Pharmaceuticals, said that the ongoing clinical trials, "will dimensionalize the first-line lung cancer space in 2018. I’m convinced there will be multiple options for different patient types in this setting which accounts for around 45 percent of the lung cancer setting. I’m also convinced that we’ll play a very important role there."
Tecentriq is a monoclonal antibody that binds with PD-L1, meaning that it’s a checkpoint inhibitor. There are at least five checkpoint inhibitors on the market now, including Merck’s Keytruda (pembrolizumab), Bristol-Myers’ Opdivo (nivolumab), Tecentriq, Pfizer Inc.’s Bavencio (avelumab) and AstraZeneca Pharmaceuticals LP’s Imfinzi (durvalumab). Although it doesn’t target PD-1 or PD-L1, Bristol-Myers’ Yervoy (ipilimumab) is also considered a checkpoint inhibitor, targeting CTLA-4.
With that kind of competition, there’s no guarantee that even if Tecentriq is approved for first-line squamous NSCLC that it will be successful in the marketplace, but it’s a start.
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