1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Astellas' Phase III Front-Line AML Study Of Xospata Fails

Standard Of Care Has Shifted Since Trial's Initiation

 
• By Alaric DeArment

One expert said the company should focus efforts on developing the drug for maintenance treatment of AML.

Acute myeloid leukemia a 3d-Render
Astellas said its Phase III study of Xospata in front-line AML did not show an overall survival benefit. • Source: Shutterstock

Development of Astellas Pharma, Inc.’s Xospata (gilteritinib) in acute myeloid leukemia (AML) may benefit from taking into account dramatic shifts since 2018 in the standard of care, following the failure of a Phase III clinical trial in newly diagnosed patients ineligible for intensive chemotherapy. The company had been hoping to expand Xospata into a new indication earlier in the treatment landscape.

However, the introduction of AbbVie Inc. and Roche Holding AG’s Venclexta (venetoclax), which is fully approved for a similar setting to the one in which the trial was...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
• By Kevin Grogan

One Phase III trial hits but a second study misses by a mile.

In Brief: Neurocrine Details New Data For Schizophrenia Drug Moving To Phase III

 
• By Sushmita Panda

Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.

Merck & Co./Daiichi Pull Patritumab Deruxtecan BLA On Disappointing OS

 
• By Jessica Merrill

Patritumab deruxtecan is the lead antibody drug conjugate in a $22bn deal signed between the two partners, with the decision marking a disappointing setback

Senti’s Computer-Logic Inspired Cell Therapy Shows Early Promise

 
• By Andrew McConaghie

The biotech believes its logic-gated cell therapies can get round the need for ‘clean targets’ which limit CAR-Ts and ADCs.

More from R&D

In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

 
• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

GSK’s Bet On Spero’s Oral cUTI Antibiotic Poised To Pay Off With New Phase III Data

 
• By Joseph Haas

Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.

Roivant Staying ‘Patient’ On Deals, Leaving Investors Waiting

 
• By Jessica Merrill

CEO Matt Gline talked to Scrip in an interview about dealmaking and the road back to commercialization.