After Second Look Oncopeptides' Melflufen Wins Head-To-Head Myeloma Trial, But Difference In OS Triggers FDA Hold

  • Oncopeptides AB ONPPF has some good news and some bad news from the updated results from Phase 3 OCEAN study of Pepaxto (melflufen) plus dexamethasone in patients with relapsed / refractory multiple myeloma who have received 2 – 4 prior lines of therapy.
  • The good news is that while preparing the clinical study report and regulatory documents, Oncopeptides discovered that the independent review committee lacked access to all the information in the clinical database.
  • The discovery led to the blinded reassessment of the full 495-patient database by the independent review committee.
  • In the final analysis, melflufen met the primary endpoint of superior Progression-Free Survival (PFS) compared to Bristol-Myers Squibb Co’s BMY Pomalyst (pomalidomide) among patients with drug-resistant multiple myeloma.
  • Data from 29 patients had to be reassessed, and the p-value on the primary slid from 0.0640 to 0.0311.
  • The bad news is that the overall survival (OS) hazard ratio (HR) was 1.104 in favor of Pomalyst.
  • Oncopeptides believes its survival results are “primarily explained by substantial HR differences between pre-specified subgroups in both directions.
  • The FDA has slapped a partial clinical hold on all trials involving the drug.
  • Price Action: The company shares tanked 22.5% to SEK74.8 on the Stockholm Stock Exchange in afternoon trading in reaction to clinical hold.
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