Phase 3 Trial of Libtayo® (cemiplimab) as Monotherapy for First-Line Advanced Non-small Cell Lung Cancer Stopped Early Due to Highly Significant Improvement in Overall Survival
Regeneron Pharmaceuticals, Inc. (REGN)
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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Source: PR Newswire
TARRYTOWN, N.Y. and PARIS, April 27, 2020 /PRNewswire/ --Libtayo decreased the risk of death by 32.4% compared to chemotherapyRegeneron and Sanofi plan regulatory submissions in 2020Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the primary endpoint of overall survival (OS) was met in a Phase 3 trial comparing the PD-1 inhibitor Libtayo® (cemiplimab) to platinum-doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) that tested positive for PD-L1 in =50% of tumor cells. Based on a recommendation by the Independent Data Monitoring Committee to stop the trial early, the trial will be modified to allow all patients to receive Libtayo for this investigational use. The data will form the basis of regulatory submissions in the U.S. and European Union (EU) in 2020."While demonstrating a survival benefit in first-line NSCLC has been challenging for immunotherapies, the one FDA-approved anti-PD-1 monotherapy
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REGN
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- 5/2/24 - Beat
REGN
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- 5/3/24 - Form 4
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- 5/2/24 - Form 10-Q
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