Eli Lilly’s antibody combo posted impressive new data.
Eli Lilly’s COVID-19 antibody combo already boasts an FDA authorization for patients at a high risk of developing severe disease, but now the company has even stronger data backing the duo.
In trial data released Wednesday, the company said its bamlanivimab-etesevimab duo slashed the risk of hospitalization and death by a whopping 87% versus placebo. Investigators tested a combination of 700 mg of bamlanivimab and 1400 mg of etesevimab in a trial comprising 769 patients total.
It’s the starkest reduction in hospitalizations and deaths for a COVID-19 therapeutic seen so far, and in a “fairly sizable” sample size, Lilly’s COVID-19 therapeutics platform leader Janelle Sabo said in an interview.
Lilly’s combo previously posted a 70% reduction in hospitalizations and deaths at higher doses of 2800 mg each. The new trial used the doses now authorized by the FDA in newly diagnosed patients at high risk of severe disease—the same population the combo is approved to treat.
The new trial reinforces other data Lilly has seen to date and shows the FDA’s authorization covers the right doses in the right patients, Sabo added.
The combo scored its emergency nod last month on the heels of the earlier data. Lilly has partnered with Amgen to help produce up to 1 million doses of the cocktail this year.
Patients over 65, or those under 65 but who are overweight or have multiple health problems, qualify as high-risk for treatment with the drug. For patients under 65, it’s “about looking at the combination of weight” and other factors, Sabo said.
In the new study, investigators tracked four hospitalizations and zero deaths among patients who received the Lilly antibody combo. That compared with 11 hospitalizations and four deaths for patients on placebo.
In the two phase 3 cohorts so far, zero patients who received the antibody combination have died, while 14 patients died on placebo. Thirteen of those placebo deaths were deemed to be related to COVID-19.
After its FDA authorization, Lilly inked another supply deal with the U.S. government covering 100,000 doses for $210 million. The doses will be delivered before the end of the month, and the government has the option to purchase 1.1 million more doses through Nov. 25 depending on demand.
While monoclonal antibodies have been available for months, initial uptake lagged expectations. Early data showed that only 1 in 20 eligible patients were getting an antibody therapeutic, Sabo said, but that has been improving to around 1 in 7.
“We still can do better,” Sabo said. “We have an obligation to continue to create awareness of therapeutics” alongside the national vaccine push that’s underway.
Originally published by
Eric Sagnowsky | March 10, 2021
Fierce Pharma
