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

New Data Set Up Padcev For Potential Expanded Use

Regulatory Discussions Planned

 
• By Ian Haydock

Positive top-line data from a second pivotal trial cohort are set to support regulatory filings for the ADC in patients whose cancer has progressed after immunotherapy but are ineligible for cisplatin.

Bladder cancer medical concept as an anatomical organ symbol with microscopic malignant cells spreading in the human body as a health care 3D illustration.
Padcev Moves Forward In Bladder Cancer • Source: Shutterstock

Astellas Pharma, Inc. and Seagen Inc. (formerly Seattle Genetics) have announced positive top-line results from a second cohort of patients in a pivotal Phase II trial with Padcev (enfortumab vedotin) in advanced urothelial cancer, paving the way for a planned US filing for a supplemental indication.

The EV-201 trial found durable responses with monotherapy in patients with locally advanced or metastatic disease previously treated with an...

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

Novartis’s Cosentyx Suffers Rare Phase III Fail

 
• By Kevin Grogan

Multi-blockbuster falls short in a giant cell arteritis study.

In Brief: Organon To Pull Plug On OG-6219 Program After Phase II Endometriosis Trial Failure

 
• By Sushmita Panda

Once hailed as a potential game changer, OG-6219 gets the axe after failing in a Phase II endometriosis-related pain trial.

In Brief: 4DMT Fast-Tracks Long-Acting Wet AMD Therapy Trials, Cuts 25% Of Workforce

 
• By Sushmita Panda

4D Molecular Therapeutics has fast-tracked its Phase III trials for 4D-150 in wet AMD, with top-line data from one now expected in H1 2027 and another underway ahead of schedule. The company is also cutting a quarter of its staff as it focuses on its late-stage pipeline and to help fund the trials.

In Brief: Atai-Beckley Deal Marches On After Phase II Psychedelic Win

 
• By Manas Mishra

The psychedelic therapy firms pass a key condition for their planned merger after the antidepressant BPL-003 meets the main endpoints of a Phase IIb trial.

More from R&D

In Brief: Atai-Beckley Deal Marches On After Phase II Psychedelic Win

 
• By Manas Mishra

The psychedelic therapy firms pass a key condition for their planned merger after the antidepressant BPL-003 meets the main endpoints of a Phase IIb trial.

BerGenBio Plumps For Oncoinvent From Long List Of 50 Suitors

 
• By Kevin Grogan

The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 
• By Sushmita Panda

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.