The Janssen Pharmaceutical Companies of Johnson & Johnson announced today overall survival (OS) results from the Phase 3 ALCYONE study (Abstract #859), which showed the addition of DARZALEX (daratumumab) to bortezomib, melphalan and prednisone (D-VMP) improved OS in patients with newly diagnosed, transplant-ineligible multiple myeloma, with a 40 percent reduction in the risk of death compared to VMP alone.

These updated data from the ALCYONE study also demonstrated that the addition of DARZALEX to VMP resulted in higher rates of minimal residual disease (MRD) negativity.1 These data are the first OS results from the ALCYONE study and are being featured during an oral session at the 2019 American Society of Hematology (ASH) Annual Meeting in Orlando. The data were simultaneously published in The Lancet.

'As a physician treating patients with multiple myeloma, I want to achieve the deepest response in the frontline setting to hopefully provide long-term benefit,' said Maria-Victoria Mateos, M.D., Ph.D., Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL, Salamanca, Spain, and a study investigator. 'This longer follow-up from the ALCYONE study is encouraging because we see that adding daratumumab to VMP in the frontline setting can provide an important overall survival advantage compared with a current standard of care.'

Results of a prespecified interim analysis, after a median duration of follow-up of more than three years, showed an estimated 42-month OS rate of 75 percent for DARZALEX-VMP versus 62 percent for VMP, with a statistically significant improvement in OS observed for DARZALEX-VMP versus VMP alone (hazard ratio [HR]=0.60; 95 percent confidence interval [CI], 0.46-0.80; P=0.0003).1 Of note, median OS was not assessed in either group and follow-up is ongoing. In addition, DARZALEX-VMP resulted in a median progression-free survival (PFS) of 36.4 months versus 19.3 months with VMP alone after a median follow-up of 40.1 months (HR=0.42; 95 percent CI, 0.34-0.51; P

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