Roche Holdings AG RHHBY announced that the Phase 3 ALINA study evaluating Alecensa (alectinib), compared with platinum-based chemotherapy, met its primary endpoint of disease-free survival (DFS) at a prespecified interim analysis.
Alecensa demonstrated a statistically significant and clinically meaningful improvement in DFS as adjuvant therapy in people with completely resected stage IB anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
Also Read: Who Are Other Players Gaining From Roche's Accidental Lung Cancer Data Update.
Overall survival (OS) data were immature at the time of this analysis. No unexpected safety findings were observed.
Results from the ALINA study will be presented at an upcoming medical meeting and submitted to health authorities globally, including the FDA and the European Medicines Agency.
Alecensa is now approved in over 100 countries as an initial (first-line) treatment for ALK-positive, metastatic NSCLC, including in the United States, Europe, Japan, and China.
Last week,
Roche inadvertently disclosed the second interim analysis of Phase 3 SKYSCRAPER-01 study, evaluating tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for PD-L1-high locally advanced or metastatic non-small cell lung cancer.
Price Action: RHHBY shares closed at $36.63 on Thursday.
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