Large differences in phase 3 overall survival spark FDA hold on Oncopeptides' multiple myeloma drug

The FDA has put all studies of Oncopeptides’ melflufen on partial hold after a blinded reassessment of phase 3 data found large differences in overall survival in pre-specified subgroups.

Oncopeptides presented top-line data from a phase 3 trial comparing its peptide-drug conjugate to Bristol Myers Squibb’s Pomalyst in multiple myeloma in May. The analysis by the independent review committee found melflufen was no better than Pomalyst in terms of progression-free survival (PFS), but the investigator assessment showed the Oncopeptides drug was superior.