Eli Lilly offered the latest indication that drugmakers may finally be honing in on how and when to use anti-beta amyloid mAbs as top-line results from the Phase II TRAILBLAZER-ALZ trial showed the agent significantly reduced plaques while also slowing the decline in cognitive and functional measures in patients with early symptomatic Alzheimer's disease (AD). In addition to tacking more than $20 billion on to the company's market cap, investor exuberance spilled over into other names like Roche and notably Biogen as speculation ran wild about what impact the readout may have on the ongoing review of the latter's aducanumab.
To provide FirstWord readers with rapid feedback on what to make of the donanemab findings, we are hosting an expert call with a key opinion leader (KOL) this week.
Key topics that will be discussed during the call include, among other things… what stands out most about the top-line TRAILBLAZER-ALZ readout; how impressed are you by donanemab's performance in the trial; how convinced are you that the results on cognition and daily function are real; how reliable is the Integrated Alzheimer's Disease Rating Scale (iADRS); does a 32% reduction in the decline on iADRS strike you as clinically meaningful; what are you most interested in seeing when the full dataset is revealed; thoughts on donanemab's safety profile, and notably the respective 27% overall and 6% symptomatic rates of amyloid-related imaging abnormalities - oedema (ARIA-E); how optimistic are you that donanemab will eventually be approved; how optimistic are you that TRAILBLAZER-ALZ could support an accelerated approval; what are the biggest question marks you have about donanemab; are there any key lessons to be learned from the way TRAILBLAZER-ALZ was designed and/or enrolled that other AD drugmakers should be especially mindful of; does this readout increase the chances that the FDA will approve aducanumab; should this readout increase the chances that the FDA will approve aducanumab; and do you see any read-through from donanemab to other anti-beta amyloid mAbs like Roche's gantenerumab or Eisai's (Biogen-partnered) lecanemab?
Ask the expert!
Furthermore, we invite FirstWord Pharma readers to submit their own questions for consideration. Please click here to do so. We can't guarantee that all questions submitted will be asked due to time constraints, but we will do our utmost to cover the important issues relating to the development and potential commercialisation of mAbs against beta amyloid and other AD therapies.
We endeavour to provide feedback from KOLs as quickly as possible. Interview content will be published for FirstWord Pharma PLUS subscribers to read. To be notified when the interview content is available please click here.
As always, FirstWord Pharma would very much like to receive your feedback and suggestions.
To read more KOL Views articles, click here.