Merck and Endocyte Announce Independen?t DSMB Recommends Vintafolid?e PROCEED Phase III Trial be Stopped
Merck (known as MSD outside the US and Canada) and Endocyte, Inc. have announced that the Data Safety Monitoring Board (DSMB) of the PROCEED trial has completed a pre-specified, interim futility analysis and the DSMB recommended that the trial be stopped because vintafolide did not demonstrate efficacy on the pre-specified outcome of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer.
The DSMB did not identify any safety concerns for the patients enrolled in the trial. Based on the DSMB recommendation and while further review of the data is conducted, the companies have taken steps to notify investigators that screening and randomization of participants in the trial will be suspended.
PROCEED is a Phase III randomized, double-blind clinical trial, evaluating vintafolide in combination with pegylated liposomal doxorubicin (PLD) compared to PLD plus placebo for the treatment of folate receptor-positive, platinum-resistant ovarian cancer. The primary endpoint of the trial was PFS as measured by RECIST v 1.1 (Response Evaluation Criteria In Solid Tumor) criteria in patients with all target tumor lesions positive as assessed by etarfolatide imaging agent.
Related News
-
News Understanding the Benefits and Advances of Cleanroom Technology
In an industry where precision and sterility are crucial concerns, cleanrooms play a vital role in maintaining the integrity of pharmaceutical products like drugs, vaccines, and other medical products. So, what is a cleanroom?
-
News AbbVie secures GBP£1.2 billion deal for Gilgamesh’s psychedelic programme
AbbVie has penned a significant agreement to acquire the bretisilocin programme from Gilgamesh Pharmaceuticals for up to £1.2 billion, marking a bold step in the pharmaceutical giant's quest to develop treatments for psychiatric disorders. -
News Gates Foundation commits US$2.5 billion to women’s health research
The Bill & Melinda Gates Foundation has announced a substantial US$2.5 billion commitment to accelerate research and development focused exclusively on women's health through 2030.
-
News Mid-year review: notable FDA drug approvals of 2025
As we fly past the halfway point of 2025, the pharmaceutical landscape reliably continues to evolve with innovative therapies addressing critical medical needs. The FDA has already approved 17 groundbreaking medications this year, each representin... -
News US FDA announces new priority vouchers for accelerated review times
The US FDA announced a new priority program for drug developers – the Commissioner’s National Priority Voucher (CNPV) program aims to enhance the health interests of the US by allowing drug developers to redeem a voucher, shortening th... -
News Google-backed start-up raises US$600 million to support AI drug discovery and design
London-based Isomorphic Labs, an AI-driven drug design and development start-up backed by Google’s AI research lab DeepMind, has raised US$600 million in its first external funding round by Thrive Capital. The funding will provide further power t... -
News AstraZeneca to invest US$2.5 billion in Beijing R&D centre
Amid investigations of former AstraZeneca China head Leon Wang in 2024, AstraZeneca have outlined plans to establish its sixth global strategic R&D centre in China. Their aim is to further advance life sciences in China with major research and manufact... -
News Experimental drug for managing aortic valve stenosis shows promise
The new small molecule drug ataciguat is garnering attention for its potential to manage aortic valve stenosis, which may prevent the need for surgery and significantly improve patient experience.