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Four years late, 50% success rate, Lilly’s solanezumab stays in PhIII

 
• By Daniel Chancellor

The earliest possible date that solanezumab is likely to reach the US Alzheimer’s market is now the end of 2017, four years later than Eli Lilly had initially hoped when it started its EXPEDITION clinical trial program. Assuming approval in mild Alzheimer’s disease, with additional off-label use in MCI patients, Datamonitor forecasts solanezumab to achieve sales of $4.0 billion across the seven major markets (the US, Japan, France, Germany, Italy, Spain and the UK) in 2021.

The earliest possible date that solanezumab is likely to reach the US Alzheimer’s market is now the end of 2017, four years later than Eli Lilly had initially hoped when it started its EXPEDITION clinical trial program. Assuming approval in mild Alzheimer’s disease, with additional off-label use in MCI patients, Datamonitor forecasts solanezumab to achieve sales of $4.0 billion across the seven major markets (the US, Japan, France, Germany, Italy, Spain and the UK) in 2021.

That is because Lilly is to test its experimental Alzheimer’s antibody in another Phase III trial, targeting mild patients only. Discussions with the FDA dissuaded Lilly from seeking immediate approval...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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ASCO: Trodelvy First-Line TNBC Data Seen As Potentially Practice-Changing

 
• By Alaric DeArment

Gilead chief medical officer Dietmar Berger said in an interview that the company plans to quickly take the results to regulators and foresees broad first-line use of the drug.

ASCO: Merck’s Zilo-V Shows Activity, But Numbers Still Small

 
• By Alaric DeArment

The drug boosted overall responses on top of the R-GemOx backbone, but the discussant pointed out that patients in waveLINE-003 were not very heavily pretreated.

Summit’s Ivonescimab Shows Significance On PFS, But Not Overall Survival

 
• By Joseph Haas

In a study intended to show similar benefit in western patients, PD-1/VEGF-targeting ivonescimab met a progression-free survival endpoint, but missed on OS.