Scientists from Regeneron recently uploaded a study write up in the preprint server medRxiv showcasing significantly positive results associated with the company’s monoclonal antibody cocktail known as REGN-CCOV or the combination of casirivimab and imdevimab. The industry-based study team found in a retrospective analysis of patients with immunodeficiencies given the monoclonal antibody cocktail as part of a compassionate use program associated with rapid viral clearance and clinical improvement in evaluable patients. TrialSite notes the initial findings are certainly promising.
Led by David M. Weinreich, SVP Late-Stage Clinical Development and Medical Affairs and Corresponding Author, the study team shared the results of their yet to be peer-reviewed retrospective, descriptive data analysis based on real world, de-identified patient data from patients who received the monoclonal antibody cocktail under emergency compassionate use from September 2, 2020, to March 29, 2021.
The study team-based protocols and process on the important Declaration of Helsinki, aligning with the International Council for Harmonization (ICH) Good Clinical Practice guidelines and applicable regulatory requirements. The authors report that they employed the use of the institutional review board of WCG.
Out of 174 patients that were approved for emergency compassionate use program 95 (54.6%) had primary and/or secondary immunodeficiency-associated antibody disorders. Of this group 85 received intravenous REGN-COV and the authors report data was available for 64 of the patients. Of those, 64 patients with available data, 37 (43.5%) had COVID-19 duration for ≥21 days prior to treatment.
In this subset 64.9% were male with a mean age of 49.1 years (median 52.0 years; min-max 1-75), 27% were ≥ 65 years, and 27/37 (73%) were inpatients.
The Regeneron-sponsored team shared that the median time from diagnosis of COVID-19 to REG-COV administration was 60.5 days. They report three patients (8.1%) had primary immunodeficiency-associated antibody disorders while 34 patients (91.9%) were diagnosed with secondary causes of immunodeficiency-associated antibody disorders—whether malignant or drug induced.
Furthermore, they report the most common causes of this status include the following:
∙ Anti-CD20 (rituximab)
∙ Acute lymphocytic leukemia
∙ Follicular lymphoma
∙ Diffuse B-cell lymphoma
∙ Other non-Hodgkin’s lymphomas
Regeneron reports that in the study population 37 with COVID-19 for either 21 days or more beyond treatment the company was able to secure data for 29 patients. Out of this cohort 23 of them or 79.3% had qualitative physician assessment at follow-up while 22 (75.9%) had oxygenation measured, and 14 (37.8%) had evaluable RT-PCR measurement after the monoclonal antibody cocktail regiment.
Positively the team found that 96.6% of patients (28/29; 95% confidence interval [CI]: 80.4-99.8) evidenced improvement in one or more of these measures following compassionate use of the investigational cocktail.
22 of the 23 patients who went through a physician assessment at follow up improved (95.7%; 95% CI: 76.0-99.8). Moreover, of those patients that experienced oxygenation 22 (100%; 95% CI: 81.5-100) has an improved oxygenation status (either greater oxygen saturation or less oxygen requirement.
11 (78.6%) of the 15 patients going through an evaluable RT-PCR test during follow-up reported negative COVID-19 test.
The Regeneron-funded team reports that this retrospective analysis reveals REGN-COV is associated with rapid viral clearance and/or clinical improvement in the evaluable patients—that is, those who had immunodeficiency-associated antibody disorders and heightened risk of persistent COVID-19.
∙ David Stein, Director Clinical Trials Management
∙ Ernesto Oviedo-Orta, Infectious Disease Lead
∙ Wendy A Kampman, Global Medical Franchise Lead
∙ Jennifer McGinniss, Director Medical Analytics
∙ George Betts, Head, Global Medical Operations
∙ Margaret McDermott, Medical Study Operations
∙ Beth Holly, SVP, Associate General Counsel
∙ Jonathan M. Lancaster, SVP Global Affairs
∙ Ned Braunstein, SVP Regulatory Affairs
∙ George D. Yancopoulos, President, Chief Science Officer, Regeneron
∙ David M. Weinreich, MD, MBA, SVP Late Stage Clinical Development and Medical Affairs, Corresponding Author