Project Team EUnetHTA assessment (PTRCR19)
Project Lead: European Network for Health Technology Assessment (EUnetHTA)
Authors:
1) Mirjana Huic (AIHTA, Austria)
2) Swiss Network for HTA (SNHTA, Switzerland)
Publication: June 2021
Language: German
The clinical evidence for bamlanivimab as monotherapy and in combination with etesevimab consists of a published 5-arm RCT with an adaptive study design (part of the patient population from phase 2 of BLAZE-1) with final results from 592 patients with mild-to-moderate SARS-CoV2 disease in an ambulant setting. In addition, unpublished results are available from the 3-arm phase 3 part of BLAZE-1 in high-risk patients with mild to moderate SARS-CoV2 disease. There are currently several registered ongoing clinical trials evaluating bamlanivimab as monotherapy and in combination with etesevimab compared to standard of care or other investigational neutralising monoclonal antibodies in the outpatient setting. The unpublished results must be interpreted with caution until a peer-reviewed publication is available. A conclusive assessment is not possible based on the current data.