A Phase III trial evaluating Libtayo® (cemiplimab) monotherapy in advanced cervical cancer has been stopped early due to a positive result on overall survival.
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The approval was based on a Phase III trial in which Libtayo reduced risk of death by 43 percent in non-small cell lung cancer patients with ≥50 percent PD-L1 expression in their tumours.
In trials Libtayo® caused clinically meaningful and durable responses, resulting in the drug being fully approved for advanced basal cell carcinoma resistant to other treatments.
In vitro neutralisation assays show REGEN-COV and AZD7442 are effective against the new SARS-CoV-2 variants, while other antibody therapies, including Eli Lilly’s bamlanivimab, were not.
Interim data from the Phase III trial evaluating REGEN-COV™ as a passive vaccine to prevent COVID-19 finds it reduces overall infection rate, viral load and length of infection.
The additional doses of casirivimab and imdevimab, two monoclonal antibodies, will be used in non-hospitalised COVID-19 patients.
REGN-COV2 will be evaluated alongside standard-of-care in a Phase III study as part of the COVID-19 RECOVERY trial.
After Kevzara (sarilumab) did not meet its primary or secondary endpoints in a Phase III trial, Sanofi and Regeneron have said they do not expect to conduct further studies on the drug against COVID-19.
As the world rushes to identify the best coronavirus treatments and vaccines, John Cahill rounds up the latest developments in potential COVID-19 therapies.
Led by Sanofi and Regeneron, clinical trials to examine Kevzara (sarilumab) as an effective COVID-19 treatment will begin in the US.
UK Biobank has announced a major initiative to sequence the full genomes of 50,000 UK Biobank volunteer participants...