New Data Set Up Padcev For Potential Expanded Use

Regulatory Discussions Planned

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

More from Clinical Trials

Early Blood Cancer Data Impresses As Incyte Plots Post-Jakafi Strategy

 
• By 

First results for a first-in-class mutCALR-targeted therapy in essential thrombocythemia presented at EHA point to a lucrative future for the early-stage product.

Who Dares Wins? Roche Moves Parkinson’s Candidate Into Phase III Despite Near Miss

 

Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Henlius CEO Details PD-L1 ADC’s Path To 1L Mono/Combo Therapy

 

Henlius is investigating the optimum dose for its PD-L1-targeting antibody-drug conjugate HLX43 to support potential first-line use, its CEO explains to Scrip.

More from R&D

UCB Follows Fellow European Pharmas With Major US Investment

 
• By 

The Belgian drugmaker is boosting its biologics capacity over the pond.

AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

 

After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.

In Brief: Starton Moves Low-Dose Lenalidomide To Phase IIa For Multiple Myeloma

 

Study to add to safety and tolerability data for infused formulation and may help identify optimal dose for future pivotal trial.