Roche’s Tecentriq, in combination with chemotherapy, hit its co-primary endpoint of progression-free survival in a Phase III trial for non-small cell lung cancer patients. But, the Swiss pharma giant said the combination has so far failed to achieve statistical significance in overall survival, a co-primary trial endpoint.
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Roche’s Tecentriq, in combination with chemotherapy, hit its co-primary endpoint of progression-free survival in a Phase III trial for non-small cell lung cancer patients. But, the Swiss pharma giant said the combination has so far failed to achieve statistical significance in overall survival, a co-primary trial endpoint.
In comparison to chemotherapy alone, the combination of Tecentriq (atezolizumab) plus chemotherapy (cisplatin or carboplatin plus pemetrexed) successfully reduced the worsening of NSCLC in patients. It also reduced the risk of patient death, Roche said. The Tecentriq/ chemo combination was being developed as a first-line defense in the treatment of advanced non-squamous non-small cell lung cancer (NSCLC).
But, when it came to overall survival, the numbers were not what Roche had been hoping to see in the Phase III IMpower 132 trial. Roche said there was a numerical improvement in overall survival, but it was not statistically significant. The overall survival data was part of an interim analysis of the combination therapy and Roche said it will continue with the study. Final overall survival data is expected to be collected next year, the company said.
NSCLC is the most common type of lung cancer. It accounts for about 85 percent of all cases. The five-year survival rate for patients diagnosed in the United States with any stage of lung cancer is estimated to be 18 percent. Overall survival is a key selling point for lung cancer treatments. Roche has been hoping its PD-L1 inhibitor can cut into some of the market share held by Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo.
News of the failure to hit the OS endpoint by this part of the trial was disappointing to some investors. Merck’s stock dipped about 1 percent to $232.35. Merck is awaiting a U.S. Food and Drug Administration (FDA) decision regarding approval of a new indication for Keytruda. In April the company said it was seeking regulatory approval for Keytruda, an anti-PD-1 therapy, in combination with Eli Lilly’s Alimta and platinum chemotherapy as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer following stellar results from the Phase III Keynote-189 clinical trial.
Deutsche Bank analyst Tim Race told Reuters that there is a general expectation that investors will see the interim results of the IMpower 132 study as a confirmation of “their fears for Tecentriq’s relative efficacy” in relation to their rival immunotherapy treatments.
While the OS data was not where Roche hoped it might be by the time of the interim analysis, the company said the safety data for the Phase III IMpower132 study, which included 578 people, has remained consistent with the known safety profile of Roche’s keystone immuno-oncology drug.
“The IMpower132 study showed Tecentriq plus chemotherapy prolonged the time people with this type of advanced lung cancer lived without their disease worsening. We will discuss these results with health authorities,” Sandra Horning, Roche’s chief medical officer and head of Global Product Development, said in a statement.
While Tecentriq provided mixed results in the lung cancer trial this week, Roche announced that Tecentriq combined with Avastin earned Breakthrough Therapy Designation from the FDA as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer. The designation is based on data from a Phase Ib study.
