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Merck/Endocyte Mulling Vintafolide’s Future After Failure In Ovarian Cancer

 
• By Lisa LaMotta

Endocyte is potentially propelled back to a Phase I company after its nearest commercial prospect flops and its collaboration with Merck is expected to disintegrate now that the drug missed PFS in ovarian cancer.

Endocyte Inc. and partner Merck & Co. Inc. have another shot with vintafolide with a lung cancer trial due to report on overall survival in the fall – but the compound took a major hit when a data safety monitoring board stopped a Phase III ovarian cancer trial due to lack of efficacy.

The drug, a conjugate of folic acid that targets folate receptors on the surface of cancer cells and is linked to the cytotoxic agent desacetylvinblastine hydrazide, was being studied in folate-positive platinum-resistant ovarian cancer patients – a small subset of the overall ovarian cancer population. The incidence of ovarian cancer in the U.S

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More from Clinical Trials

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

More from R&D

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.