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. 

The announcement of the clinical hold, on 8 July, was accompanied by a sharp decline in the company share’s price...

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

J&J’s Trispecific Antibody For Myeloma Offers Improved Safety, Potency Over Bispecifics

 
• By Alaric DeArment

The drugmaker presented data from its Phase I study of JNJ-79635322 at ASCO and EHA showing a 100% response rate in BCMA- and GPRC5D-naïve patients.

ASCO: Pushing The Frontiers Of ADCs

 
• By Mary Jo Laffler

Antibody-drug conjugates are a major part of the oncology pipeline, and data presented at the American Society of Clinical Oncology meeting highlight the emergence of new technologies.

Immuneering Could Partner Atebimetinib Or Go It Alone After Phase IIa Success

 
• By Alaric DeArment

CEO Ben Zeskind said all options are on the table after atebimetinib showed impressive results in pancreatic cancer.

Enliven Raises $230m To Fund Scemblix Leukemia Challenger

 
• By Andrew McConaghie

The company believes its drug could eventually displace Novartis’s Scemblix in first-line chronic myeloid leukemia treatment, but for now is preparing for a second-/third-line pivotal study.

More from Therapy Areas

Scholar Rock Shows Muscle-Building PoC In Obesity

 
• By Jessica Merrill

The company said it intends to maintain a focus on rare neuromuscular disease with apitegromab but could consider partnering in obesity.

Spyre Takes Aim At Roche And J&J In Inflammatory Diseases

 
• By Andrew McConaghie

The US firm was already looking to compete in ulcerative colitis, but now expands its ambitions by moving into rheumatoid arthritis as well.

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By Kevin Grogan

Wales-based group launches with $140m series A.