1. Scrip
  2. >>Therapy Areas
  3. >>Anticancer

Phase III Analyses Prompt Partial Clinical Hold On Oncopeptides' Melflufen Studies

OCEAN OS Data Favors Active Comparator

 
• By John Davis

Oncopeptides AB’s melflufen (Pepaxto) has met the primary PFS endpoint in the Phase III OCEAN study, designed to extend its reach into earlier-stage multiple myeloma patients, but overall survival data favors the comparator in patient subgroups, and melflufen in others, leading to regulators pausing clinical trials to review the results.

multiple myeloma
• Source: Alamy

Oncopeptides AB’s plans to develop its lead product, Pepaxto (melflufen, also known as melphalan flufenamide), for earlier-stage multiple myeloma patients could be temporarily held up by a partial clinical hold put on clinical studies requested by the US Food and Drug Administration, following updated analyses from the Phase III OCEAN study. 

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 Anticancer

Bristol’s Opdivo + Yervoy Gets FDA Liver, Colorectal Cancer Nods

 
• By Joseph Haas

Bristol Myers Squibb notched two approvals in one week for its immuno-oncology combination, pitting the regimen head-to-head with Keytruda in a subset of CRC and with two combos in HCC.

Novartis $23bn US Investment Is Music To Trump’s Ears

 
• By Kevin Grogan

The Swiss major follows Lilly and J&J in committing to a significant spend on US manufacturing.

Ferring’s Faith In Bladder Cancer Gene Therapy Starts To Pay Off

 
• By Kevin Grogan

Adstiladrin sales hit €70m in first full year on the market

Vocal For ‘Glocal’: How Menarini Is Adapting To Outperform In The Asia Pacific

 
• By Anju Ghangurde

Menarini's Asia-Pacific CEO talks to Scrip about how the Italian group is tailoring its portfolio and pricing approach to local markets making strong strides in primary care and consumer health, while also charting a distinct path in rare diseases and oncology. The China market is also a key focus including as a potential source of innovation as is partnering, where the group has a rich history.

More from Therapy Areas

Ferring’s Faith In Bladder Cancer Gene Therapy Starts To Pay Off

 
• By Kevin Grogan

Adstiladrin sales hit €70m in first full year on the market

Multiple Tactics Likely Needed To Control Obesity Drug Costs

 
• By Alaric DeArment

ICER’s new white paper pointed to estimates that the GLP-1 drugs may result in more than $100bn in annual spending, highlighting the need to rein in costs.

Cartesian Maps Out CAR-T Strategy With Simpler Logistics In Mind

 
• By Alaric DeArment

The company announced positive Phase IIb data for Descartes-08 in myasthenia gravis, with especially strong efficacy among patients without prior biologic treatment.