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.<\/p>\n
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.<\/p>\n
The decision to stop the trial early was based on a recommendation by the Independent Data Monitoring Committee. <\/p>\n
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.<\/p>\n
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.<\/p>\n
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. <\/p>\n
The drug is also approved for the treatment of cutaneous squamous cell carcinoma (CSCC), and basal cell carcinoma (BCC).<\/p>\n
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.<\/p>\n
REGN closed Wednesday’s trading at $580.95, down 0.95%. In pre-market trading Thursday, the stock is up 3.28% at $600. <\/p>\n