{"id":39288,"date":"2020-11-11T07:26:37","date_gmt":"2020-11-11T07:26:37","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=39288"},"modified":"2020-12-11T09:05:51","modified_gmt":"2020-12-11T09:05:51","slug":"press-release-results-on-regn-cov2-a-monoclonal-antibody-combination-used-in-uk-recovery-study","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/39288","title":{"rendered":"DSMB stops REGN-COV2 (casirivimab\/imdevimab) monoclonal antibody study in people with high-flow oxygen or ventilation: implications for UK RECOVERY study"},"content":{"rendered":"<div><\/div>\n<p><span lang=\"EN-US\"><strong><img loading=\"lazy\" decoding=\"async\" class=\" alignright\" src=\"https:\/\/i-base.info\/wp-content\/uploads\/2020\/03\/COVID-19-graphic.png\" width=\"231\" height=\"142\" \/>Simon Collins, HIV i-Base<\/strong><\/span><\/p>\n<p><strong><span lang=\"EN-US\">On 30 October 2020, the DSMB for a study of REGN-COV2 (casirivimab\/imdevimab \u2013 a combination of two monoclonal antibodies against COVID-19), recommended stopping use in participants needing high-flow oxygen or ventilation due to a potential safety signal and an unfavourable risk\/benefit profile in this group. [1]<\/span><\/strong><\/p>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The trial is designed to enrol patients in four independently randomised cohorts:<\/span><\/p>\n<\/div>\n<div>\n<ul>\n<li class=\"HTBBODYtext\"><span lang=\"EN-US\">Cohort 1: patients on low-flow oxygen\u00a0<\/span><\/li>\n<li class=\"HTBBODYtext\">Cohort 1A: patients not requiring oxygen<\/li>\n<li class=\"HTBBODYtext\">Cohort 2: patients on high-flow oxygen<\/li>\n<li class=\"HTBBODYtext\">Cohort 3: patients on mechanical ventilation<\/li>\n<\/ul>\n<\/div>\n<p>Continued enrolment is allowed in participants in earlier infection, and in a separate outpatient study.<\/p>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">This notice came only two days after a press release from the manufacturer reporting a second set of positive results from a phase 2\/3 study. [2]<\/span><\/p>\n<\/div>\n<p><span lang=\"EN-US\">This reported both reductions in viral load and <\/span>hospital visits in 524 participants with mild to moderate COVID-19 randomised to active treatment or placebo, both with standard of care.<\/p>\n<p>Participants were prospectively categorised by whether or not they had already generated an antibody response to COVID-19 (38% positive, 51% negative and 11% unclear\/unknown).<\/p>\n<p>The results are similar to earlier results on an initial 275 participants released by press statement last month. [3]<\/p>\n<p>The new results (n=524) included:<\/p>\n<div>\n<ul>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">Mean change from baseline in viral load was 0.68 log<sub>10<\/sub>copies\/mL lower at day 7 reduction with REGN-COV2 vs placebo (combined dose groups; p&lt;0.0001).<\/span><\/li>\n<li class=\"HTBBODYindent\">A 1.08 log greater reduction with REGN-COV2 vs placebo by day 5.<\/li>\n<li class=\"HTBBODYindent\">In the overall patient group with detectable virus at baseline, the average daily reduction in viral load through day 7 was a 0.36 log10 copies\/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p=0.0003).<\/li>\n<li class=\"HTBBODYindent\">Higher baseline viral load and\/or no detectable antibodies at baseline was associated with greater benefit from REGN-COV2.<\/li>\n<\/ul>\n<p>The results in the total analysis (n=799) included:<\/p>\n<\/div>\n<div>\n<ul>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">On a primary clinical endpoint, REGN-COV2 reduced COVID-19 related medical visits by 57% through day 29 (2.8% combined dose groups; 6.5% placebo; p=0.024).\u00a0<\/span><\/li>\n<li class=\"HTBBODYindent\">Treatment with REGN-COV2 reduced COVID-19 related medical visits by 72% in patients with one or more risk factor (including being over 50 years of age; body mass index greater than 30; cardiovascular, metabolic, lung, liver or kidney disease; or immunocompromised status) (combined dose groups; nominal p=0.0065).<\/li>\n<\/ul>\n<\/div>\n<p>The results have been reported to the US FDA and will be compiled and submitted for publication.<\/p>\n<p>REGN-COV2 is being developed in the US by Regeneron Pharmaceuticals and is currently in studies for hospitalised and non-hospitalised COVID-19 and as prophylactic prevention.<\/p>\n<p>REGN-COV2 was also recently added as a new option in the UK RECOVERY study. [4]<\/p>\n<p>In August, Regeneron partnered with Roche Pharmaceuticals to increase production of REGN-COV2. [5]<\/p>\n<div>\n<h3 class=\"HTBBODYtext\"><span lang=\"EN-US\">comment<\/span><\/h3>\n<\/div>\n<div>\n<div>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">Further clinical details about the DSMB decision were not included in the press release.<\/span><\/strong><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">Although the virological results hint at a positive effect of the dual antibodies, any publication in a company press release needs to interpreted with caution.\u00a0Without more details it is difficult to comment further.<\/span><\/strong><\/p>\n<\/div>\n<\/div>\n<div>\n<p class=\"HTBreferences\"><span lang=\"EN-US\">References<\/span><\/p>\n<\/div>\n<div>\n<div>\n<ol>\n<li class=\"HTBreferences\"><span lang=\"EN-US\">REGN-COV2 independent data monitoring committee recommends holding enrollment in hospitalized patients with high oxygen requirements and continuing enrollment in patients with low or no oxygen requirements. (30 October 2020).<br \/>\n<\/span><a href=\"https:\/\/investor.regeneron.com\/news-releases\/news-release-details\/regn-cov2-independent-data-monitoring-committee-recommends\" rel=\"noopener noreferrer\">https:\/\/investor.regeneron.com\/news-releases\/news-release-details\/regn-cov2-independent-data-monitoring-committee-recommends<\/a><\/li>\n<li class=\"HTBreferences\">Regeneron&#8217;s covid-19 outpatient trial prospectively demonstrates that REGN-COV2 antibody cocktail significantly reduced virus levels and need for further medical attention. (29 October 2020.<br \/>\n<a href=\"https:\/\/newsroom.regeneron.com\/news-releases\/news-release-details\/regenerons-covid-19-outpatient-trial-prospectively-demonstrates\" rel=\"noopener noreferrer\">https:\/\/newsroom.regeneron.com\/news-releases\/news-release-details\/regenerons-covid-19-outpatient-trial-prospectively-demonstrates<\/a><\/li>\n<li class=\"HTBreferences\">Regeneron&#8217;s REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalized COVID-19 patients. (29 September 2020).<br \/>\n<a href=\"https:\/\/investor.regeneron.com\/news-releases\/news-release-details\/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and\" rel=\"noopener noreferrer\">https:\/\/investor.regeneron.com\/news-releases\/news-release-details\/regenerons-regn-cov2-antibody-cocktail-reduced-viral-levels-and<\/a><\/li>\n<li class=\"HTBreferences\">The RECOVERY study. RECOVERY COVID-19 phase 3 trial to evaluate Regeneron\u2019s REGN-COV2 investigational antibody cocktail in the UK. (14 September 2020).<br \/>\n<a href=\"https:\/\/www.recoverytrial.net\/news\/recovery-covid-19-phase-3-trial-to-evaluate-regeneron2019s-regn-cov2-investigational-antibody-cocktail-in-the-uk\" rel=\"noopener noreferrer\">https:\/\/www.recoverytrial.net\/news\/recovery-covid-19-phase-3-trial-to-evaluate-regeneron2019s-regn-cov2-investigational-antibody-cocktail-in-the-uk<\/a><\/li>\n<li>\n<div>Roche press release.\u00a0Roche and Regeneron collaborate to significantly increase global supply of REGN-COV2 investigational antibody combination for COVID-19. (19 August 2020).<\/div>\n<div><a href=\"https:\/\/www.roche.com\/media\/releases\/med-cor-2020-08-19.htm\" rel=\"noopener noreferrer\">https:\/\/www.roche.com\/media\/releases\/med-cor-2020-08-19.htm<\/a><\/div>\n<\/li>\n<\/ol>\n<p><em>This report was first posted on 30 October 2020.<\/em><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 30 October 2020, the DSMB for a study of REGN-COV2 (casirivimab\/imdevimab \u2013 a combination of two monoclonal antibodies against COVID-19), recommended stopping use in participants needing high-flow oxygen or ventilation due to a potential safety &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[283,278],"tags":[],"class_list":["post-39288","post","type-post","status-publish","format-standard","hentry","category-covid-19-investigational-drugs","category-covid-19"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/39288","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=39288"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/39288\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=39288"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=39288"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=39288"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}