Regeneron Pharmaceuticals Inc. (REGN) and Sanofi’s (SNY) phase III trial of Libtayo combined with chemotherapy has been stopped early due to significant improvement in overall survival in patients with first-line advanced non-small cell lung cancer.
In the phase III trial, dubbed EMPOWER-Lung 3, a first-line combination treatment of Libtayo and platinum-doublet chemotherapy was compared to platinum-doublet chemotherapy alone in squamous or non-squamous advanced non-small cell lung cancer patients, irrespective of PD-L1 expression. The trial had enrolled 466 patients.
The decision to stop the trial early was based on a recommendation by the Independent Data Monitoring Committee.
In the EMPOWER-Lung 3 trial, Libtayo combined with chemotherapy increased median overall survival from 13 to 22 months, leading to a 29% reduction in the risk of death.
The EMPOWER-Lung 3 data are planned to form the basis of regulatory submissions in the U.S. and European Union when the companies seek to expand the label of Libtayo.
Libtayo as monotherapy was approved for the first-line treatment of patients with non-small cell lung cancer whose tumors have high PD-L1 expression as recently as February of this year. In trial settings, Libtayo as monotherapy reduced the risk of death by 32% compared to chemotherapy.
The drug is also approved for the treatment of cutaneous squamous cell carcinoma (CSCC), and basal cell carcinoma (BCC).
Libtayo registered annual sales of about $348 million in 2020, up 80% over 2019. The drug’s sales in the first quarter of 2021 were $69 million compared to $62 million in the year-ago quarter.
REGN closed Wednesday’s trading at $580.95, down 0.95%. In pre-market trading Thursday, the stock is up 3.28% at $600.
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