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So Far, Still So Good For Seattle Genetics/Astellas’ Bladder Cancer ADC

 
• By Alexandra Shimmings

Updated data from the Phase II EV-201 study of Seattle Genetics/Astellas Pharma’s novel ADC are strong enough to warrant accelerated approval, its investigators claim. An accelerated submission to the US FDA is due later this year.

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

Updated data from the first cohort of the Phase II EV-201 study of Seattle Genetics Inc./Astellas Pharma Inc.’s antibody-drug conjugate enfortumab vedotin continue to impress, with a confirmed 44% objective response rate and a median survival time of 11.7 months in a heavily pre-treated advanced urothelial cancer population.

Principal investigator Daniel Petrylak at Yale Cancer Center, who presented at the American Society of Clinical Oncology meeting in Chicago on 3 June, said enfortumab vedotin (EV) was the first novel product to show clinical activity in patients who have progressed after platinum chemotherapy and a PD-1/L1 inhibitor, the

More from ASCO

TIL The CARs Come Home: How Cell Therapy’s Solid Tumor Future Is Shaping Up

 
• By Alaric DeArment

Iovance’s Amtagvi won FDA accelerated approval in February, and Adaptimmune’s afami-cel may not be far behind, but cell therapies for solid tumors come with some extra challenges.

Anti-TROP2 ADCs Lung Cancer Futures Likely Lie In Earlier-Stage Disease

 
• By Alaric DeArment

The discussant at ASCO’s NSCLC session said the field would need to “manage expectations” as the drugs do not appear to beat chemotherapy in all-comers. 

ASCO 2024 Wrap-Up Podcast

 
• By Alaric DeArment

Scrip reporter Alaric DeArment is joined by the Datamonitor Healthcare oncology analysts to review key highlights from the recent American Society of Clinical Oncology annual meeting.   

China Biotech Podcast: BIOSECURE Act Updates ASCO Highlights

 
• By Brian Yang and Dexter Jie Yan

US-based Citeline writer Sarah Karlin-Smith joins Brian Yang and Dexter Yan in China to discuss the US BIOSECURE Act and the recent BIO meeting in San Diego, while Dexter Yan discusses China-related ASCO highlights, in this mixed Chinese- and English-language episode.

More from Conferences

Cash-Strapped Chinese Biotechs A Growing Draw For Western Pharma Partnering

 
• By Alaric DeArment

Nauman Shah, head of business development for J&J Innovation, sat down at the BIO CEO & Investor Conference to talk about his trip to China and the state of the biotech scene there.

Lexicon Has A Lot Riding On LX9211 Phase IIb Readout In Pain

 
• By Jessica Merrill

CEO Mike Exton talked to Scrip about moving the company forward after a disappointingly disruptive 2024.

Reflections From Biotech Leader John Maraganore

 
• By Jessica Merrill

The founder and director of City Therapeutics and founding CEO of Alnylam discussed pressing issues facing the biotech sector in a fireside chat at the recent BIO CEO & Investor Conference.