The results of Regeneron’s monoclonal antibody combination arm of the RECOVERY trial have been announced, finding that the antibody combination reduces deaths for hospitalised COVID-19 patients who have not mounted their own immune response
This Roundup accompanied an SMC Briefing.
Dr Kovilen Sawmynaden, Principal Scientist, LifeArc, said:
“From these findings, the treatment appears to represent a real opportunity to treat those patients without existing antibodies, such as immunocompromised patients (e.g. people receiving cancer treatment or organ transplants) within a hospital setting.
Up until now, monoclonal antibodies have shown little benefit as treatment once patients have been hospitalised, so it would be good to see if this replicates in larger/other patient groups.
Due to the quantities (8 grams total) this treatment can only be given by IV injection in a hospital setting and not via a simple injection in the arm. This will probably limit its use.”
Dr Penny Ward, Faculty of Pharmaceutical Medicine, Visiting Professor in Pharmaceutical Medicine, Kings College London, said:
“It is very good news that the Regeneron antibody cocktail has performed well in the RECOVERY trial, although the results reported in the press release call into question their previous analysis of the convalescent plasma portion of the trial which did not show any benefit. As both convalescent plasma might be expected to have a similar impact (assuming adequate levels of neutralising antibody in the infusate) as the combination artificial MAb combination, it would seem appropriate now to revisit the data for convalescent plasma and apply the same analysis. Regrettably, the press release does not supply information on other baseline features of the seronegative vs seropositive portion of the patient population which should include age, gender, time from symptom onset and preCOVID health status which might provide additional insight for efficient use of this product, and additionally confirm that this effect was observed in addition to the contribution of corticosteroid. I look forward to seeing the detailed data in the submitted publication.”
Prof Fiona Watt, Executive Chair, Medical Research Council, said:
“The flagship RECOVERY trial once again leads the way in showing the importance of well-designed clinical trials to identify life-saving treatments. This very important finding means, for patients hospitalised with COVID-19 who do not make their own antibodies to the virus, being treated with antibody-based drugs to the spike protein can reduce their risk of death and time spent in hospital. Patients who have made their own antibodies to the virus do not benefit from the new treatment, which is also important information given the cost of drugs.”
Dr Jane Osbourn OBE, Former Chair of the BIA COVID-19 Antibody Taskforce, said:
“It is great to see an antibody combination therapy saving lives and reducing disease burden; likely more on the way in coming months and years and this is an area U.K. expertise can drive to further discover and develop.”
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“The press release on this trial gives some helpful information, though it would be better to have the full pre-print to comment.
“About 30% of patients admitted to hospital in the period of this trial had not mounted a measurable antibody response of their own to the virus. It is not clear whether they were all unvaccinated or not but we do know that some people with a poor immune status (“immunocompromised”) do not easily produce such antibodies and require two doses of a vaccine.
“The absolute magnitude of benefit in mortality is not large, and it means that a large (possibly 20) number of people have to be treated with the extremely expensive drug for a single death to be prevented.
“The costs of these drugs tends to be very high, and the calls for cheaper vaccines might be repeated for these drugs, which are essentially only available in very rich countries.
“It is very good to know that drugs, targeted at the virus itself, can affect the outcome in patients in hospital. If there is a small group of people whose response to a vaccine is poor or non-existent, and who become ill after infection with the virus, can be readily identified and treated it will have some benefit in practice, but its benefits should not be overstated. Reducing mortality in such people from 30% to 24% is good, but even this benefit may be less when the drug is used in practice. The majority of those whose condition is severe and who will die, will still die when given the drug. The benefit to those who survive is clear though and doing large well-conducted trials of this type is the way to find whether benefits are real and what their magnitude really is.”
All our previous output on this subject can be seen at this weblink:
Dr Kovilen Sawmynaden: “LifeArc is a medical research charity. We are part of the BIA Antibody Taskforce to identify potential neutralising antibodies for Sars-Cov-2, donating our time and efforts on this project. We do not have a connection with the RECOVERY trial.”
Dr Jane Osbourn: “Jane is Chief Scientific Officer of Alchemab Therapeutics and they have published some work on COVID-19 antibodies.”
Prof Fiona Watt: “MRC helped fund the study.”
Prof Stephen Evans: “No conflicts of interest. I am funded (one day per week) by LSHTM. They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them. I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI. I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs. I am a participant in the Oxford/Astra Zeneca trial, and on 13th January 2021 learnt I had received the active vaccine.”
None others received.