Lilly leaves investors itching for more details

 Lilly and Almirall’s atopic dermatitis contender lebrikizumab has prevailed in its pivotal trials, Advocate 1 and 2. But, other than the groups saying “more than half” of patients achieved 75% skin clearance, or Easi-75, details were thin on the ground. Investors will have to wait for an undisclosed 2022 medical meeting to see whether lebri has held its own in a cross-trial comparison against Sanofi and Regeneron’s Dupixent. The signs are good: in Dupixent’s pivotal trials, 51 and 44% of patients receiving the drug every other week met Easi-75 on a non-placebo-adjusted basis. It will also be important to see how lebri performed on its second co-primary endpoint, the proportion of patients with an IGA score of 0 or 1. Another factor is how different dosing regimens of lebri fared: patients received the drug every two or four weeks, potentially giving lebri a convenience advantage over Dupixent. Finally, safety will be on the agenda as it is hoped that lebri could sidestep the issue of conjunctivitis, which occurred in 10% of patients in Dupixent’s monotherapy trials. Lilly said today that conjunctivitis was one of the most common adverse events seen with lebri, so actual numbers will be keenly awaited.  

Awaiting detailed data: what lebri needs to do in phase 3
Endpoint	Dupixent ph3*	Lebri ph2**
IGA 0 or 1	27-28 points	19-30 points
EASI-75	32-36 points	32-37 points
EASI-90	23-28 points	25-33 points
Note: all values placebo-adjusted; *monotherapy ph3 trials (Solo-1 & Solo-2); **250mg every 4wks & 250mg every 2wks, all secondary endpoints. Source: Dupixent label & JAMA Dermatology.

 

Lebri's phase 3 trials
Study name/ID	Details	Data
Advocate 1, NCT04146363	Placebo-controlled, lebri monotherapy every 2/4 wks	Topline data released; positive
Advocate 2, NCT04178967	Placebo-controlled, lebri monotherapy every 2/4 wks	Topline data released; positive
Adhere, NCT04250337	Placebo-controlled, lebri + topical corticosteroids every 2 wks	Completes Aug 2021
Adore, NCT04250350	Adolescents, single-arm, lebri every 2 wks	Completes Apr 2022
Adjoin, NCT04392154	Long-term extension, lebri every 2/4 wks	Completes May 2024
Source: Evaluate Pharma & clinicaltrials.gov. https://www.evaluate.com/vantage/articles/news/snippets/lilly-leaves-investors-itching-more-details