Swiss drug major Roche Group (RHHBY) and its U.S. unit Genentech announced Monday positive results from Phase III IMpower010 study evaluating Tecentriq (atezolizumab) in people with early lung cancer.
According to the companies, Tecentriq in the trial met its primary endpoint of disease-free survival or DFS at the interim analysis in people with resectable early stage lung cancer compared to best supportive care or BSC.
Tecentriq showed a statistically significant improvement in DFS as adjuvant therapy following surgery and chemotherapy in all randomised Stage II-IIIA populations with non-small cell lung cancer or NSCLC.
It is the first Phase III study that shows a cancer immunotherapy helped people with early lung cancer live longer without their disease returning.
The companies will submit the IMpower010 study data to health authorities globally as soon as possible, including the U.S. Food and Drug Administration and the European Medicines Agency. The data will also be presented at an upcoming medical meeting.
Follow-up will continue with planned analyses of DFS in the overall intent-to-treat or ITT population, which at the time of analysis did not cross the threshold, and overall survival data, which were immature at the time of interim analysis.
Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, said, “With these landmark results, Tecentriq has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning. We’re excited by the clinical benefit adjuvant Tecentriq may bring to lung cancer patients, particularly in the PD-L1-positive population.”
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