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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. 

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