Donanemab Ph3 results are out
Lilly's donanemab Ph3 TRAILBLAZER ALZ-2 full results are out. A few really interesting observations from my perspective:
1. By 76 weeks, nearly 4 in 5 patients have complete brain amyloid clearance. That brings up the question of when to stop the therapy. Donanemab clears the existing amyloid, but it doesn't stop the amyloid production, so there's argument for not stopping the treatment. It will be interesting to see Lilly or others will attempt to address this question and the question of whether and when to re-initiate the therapy. These questions are not just of scientific curiosity but also of clinical and societal relevance, given its safet profile and high costs.
2. The disease slowing benefit is much stronger in MCI than in mild and moderate patients. This is a good argument for intervening earlier.
3. Interestingly, there is also a disease slowing benefit in moderate patients, though from the percentage point of view, the effect is not as strong as in MCI and mild patients. This could be an argument for not stopping the treatment simply because patients progress into moderate stage.
Overall, 23 out of 24 gated outcomes reached statistical significance. The drug's efficacy is indisputable. How the practicing neurologists and patients/caregivers view the safety profile will be key to its commercial success!