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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...

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