{"id":39268,"date":"2020-11-11T07:25:22","date_gmt":"2020-11-11T07:25:22","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=39268"},"modified":"2020-11-13T12:38:06","modified_gmt":"2020-11-13T12:38:06","slug":"monoclonal-antibody-study-stopped-early-bamlanivimab-shows-lack-of-benefit-in-people-hospitalised-with-covid-19","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/39268","title":{"rendered":"Monoclonal antibody stopped in ACTIV-3 study: bamlanivimab shows lack of benefit in people hospitalised with COVID-19"},"content":{"rendered":"
Simon Collins, HIV i-Base<\/span><\/strong><\/div>\n

On 26 October 2020, a press statement from Eli Lilly reported that it had stopped further recruitment of the monoclonal antibody <\/span>bamlanivimab (LY3819253) into a study of people hospitalised with COVID-19. [1, 2]<\/strong><\/p>\n

A press release issued by the US NIAID who sponsor the ACTIV-3 study included more details – and although this compound has been stopped, the ACTIV-3 study will continue. [3]<\/p>\n

This study is designed to investigate promising compounds as treatment for late-stage COVID-19. All participants receive standard of care that includes remdesivir.<\/p>\n

The decision to stop bamlanivimab followed a predefined efficacy review by the Data and Safety Monitoring Board (DSMB) on the first 300 participants (stage 1), based on clinical benefits after five days on an ordinal scale. Recruiting a further 700 participants only occurs (stage 2) depends on seeing an early signal of efficacy.<\/p>\n

The DSMB review showed that bamlanivimab was \u201cunlikely to help\u201d people with hospitalised COVID-19 \u201crecover from this advanced stage of their disease\u201d. There were no significant safety issues.<\/p>\n

No further details have been released yet on the study or these early results.<\/p>\n

Other studies with bamlanivimab, in different populations, are continuing. These include:<\/p>\n

\n
    \n
  1. ACTIV-2 in people recently diagnosed in mild to moderate COVID-19, also sponsored by the US NIH (also overseen by the same DSMB). [4]<\/li>\n
  2. BLAZE-1, an ongoing phase 2 trial in people recently diagnosed with earlier stage non-hospitalised COVID-19, also in combination with etesevimab. Interim results were just published in NEJM. [5, 6]<\/li>\n
  3. BLAZE-2, an ongoing\u00a0phase 3 study of bamlanivimab as prophylaxis in residents and staff living in care facilities. [7]<\/li>\n<\/ol>\n<\/div>\n
    \n
    \n

    comment<\/span><\/h3>\n<\/div>\n
    \n

    Although the results are disappointing the study itself shows the importance of being able to rapidly identify likely futility with this particular monoclonal antibody.<\/strong><\/p>\n<\/div>\n

    The ACTIV-3 study is an adaptive platform study that is designed to study multiple investigational compounds compared to placebo and further drugs are due to be added shortly.<\/strong><\/p>\n

    References<\/p>\n<\/div>\n

    \n
      \n
    1. Lilly statement regarding NIH\u2019s ACTIV-3 clinical trial.
      \n<\/span>https:\/\/www.lilly.com\/news\/stories\/statement-activ3-clinical-trial-nih-covid19<\/a><\/li>\n
    2. ACTIV-3: Therapeutics for Inpatients With COVID-19 (TICO).
      \n      https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04501978<\/a><\/li>\n
    3. NIH Statement. NIH-sponsored ACTIV-3 trial closes LY-cov555 sub-study. (26 October 2020).
      \n      https:\/\/www.niaid.nih.gov\/news-events\/statement-nih-sponsored-activ-3-trial-closes-ly-cov555-sub-study<\/a><\/li>\n
    4. ACTIV-2: A study for outpatients with COVID-19.
      \n      https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04518410<\/a><\/li>\n
    5. A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in participants with mild to moderate COVID-19 illness.
      \n      https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04427501<\/a><\/li>\n
    6. Chen P. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19. NEJM,\u00a0DOI: 10.1056\/NEJMoa2029849. (28 October 2020).
      \n      https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2029849<\/a><\/li>\n
    7. A Study of LY3819253 (LY-CoV555) in preventing SARS-CoV-2 infection and COVID-19 in nursing home residents and staff.
      \n      https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04497987<\/a><\/li>\n<\/ol>\n

      This report was first posted on 28 October 2020.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

      Simon Collins, HIV i-Base On 26 October 2020, a press statement from Eli Lilly reported that it had stopped further recruitment of the monoclonal antibody bamlanivimab (LY3819253) into a study of people hospitalised with COVID-19. [1, 2] A press release …<\/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-39268","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\/39268","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=39268"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/39268\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=39268"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=39268"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=39268"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}