Christie’s COVID-19 treatment raises fairness, safety questions
Former New Jersey Gov. Chris Christie’s treatment for COVID-19 raises questions about the fairness of decisions to grant access to investigational therapies, as well as the safety of exposing patients to untested drug combinations.
Instead of being treated with a mAb product from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) that is being tested at the facility where he was hospitalized, Christie received a mAb cocktail that Eli Lilly and Co. (NYSE:LLY) is testing in COVID-19 patients who have less severe symptoms.
Christie received Lilly’s investigational mAb product after he was denied compassionate use access to Regeneron’s mAb — the drug that President Donald Trump received — according to a source at the Morristown Medical Center where he was treated who requested not to be identified because they were not authorized to speak to the media.
Christie was offered the opportunity to enroll in a trial of REGN-COV2. The medical center is a trial site for a trial of the mAb cocktail, Regeneron spokesperson Alexandra Bowie confirmed to BioCentury.
He declined because the randomized trial includes a placebo arm, and he was unwilling to accept the chance that he would receive a placebo, the source told BioCentury.
Christie’s office did not respond to an inquiry from BioCentury.
Bowie told BioCentury in an email that the company does not “comment on individual patient care or compassionate use requests (including who may or may not have submitted one), beyond what the patient may disclose themselves.”
Lilly spokesperson Molly McCully told BioCentury by email that “as a matter of policy, Lilly does not comment or speculate about individual patient information.” She added: “Lilly is willing to consider individual patient Expanded Access for our antibody therapy on a case-by-case basis. In exceptional circumstances, Lilly may support expanded access to patients — at the request of their physician — who meet pre-determined clinical criteria and who are unable to participate in a clinical trial.”
The Lilly combination mAb product is in short supply. The company expects to have 50,000 doses available this year and to ramp up supply “substantially” in 1Q21.
In a statement announcing his recovery from COVID-19, Christie thanked “the manufacturers of Remdesivir and the Eli Lilly monoclonal antibody cocktail for giving me access to their extraordinary treatments.”
Christie received a combination of two mAbs that is being studied for patients whose circumstances are different from his, and that has not been studied with Veklury remdesivir from Gilead Sciences Inc. (NASDAQ:GILD).
The cocktail he received, a combination of bamlanivimab (LY-CoV555) and etesevimab LY-CoV016 from Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877; Shanghai:688180), is being studied in patients with mild to moderate COVID-19 who have not been hospitalized. Christie was treated in a hospital ICU.
An interim analysis of the BLAZE-1 trial of bamlanivimab and etesevimab showed that the combination therapy “reduced viral load, symptoms and COVID-related hospitalization and ER visits,” according to a Lilly press release.
The combination of the cocktail with Veklury is not currently being tested.
An NIH data safety monitoring board (DSMB) has raised safety concerns about the combination of Veklury and bamlanivimab,
Following a safety alert from a DSMB, on Oct. 14 NIH’s National Institute of Allergy and Infectious Diseases announced that it had halted a trial of the combination of bamlanivimab and Veklury. The study was paused after the DSMB reported it had “reached a predefined boundary for safety at day five” — a safety threshold set based on the difference between adverse events in the bamlanivimab plus Veklury arm and control arms. NIAID is scheduled to consider continuing the pause or resuming the trial at an Oct. 26 meeting.