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ARTICLE | Clinical News

Genmab's Darzalex meets in Phase III for first-line MM

August 28, 2017 11:10 PM UTC

Genmab A/S (CSE:GEN; Pink:GMXAY) reported top-line data from a pre-planned interim analysis of the Phase III ALCYONE (MMY3007) trial showing that Darzalex daratumumab (HuMax-CD38) plus Velcade bortezomib, melphalan and prednisone (VMP) as first-line treatment of multiple myeloma (MM) met the primary endpoint of improving progression-free survival (PFS) vs. VMP alone (HR=0.5, 95% CI: 0.38, 0.65, p<0.0001). Median PFS in the Darzalex arm has not been reached, while the estimated median PFS in the VMP arm was 18.1 months. Based on the interim results, an IDMC has recommended unblinding the data.

The open-label, international trial enrolled 706 patients with newly diagnosed MM who were ineligible for autologous stem cell transplantation (ASCT). Secondary endpoints in the trial include time to disease progression, overall survival (OS), overall response rate (ORR) and duration of response...

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Genmab A/S

Johnson & Johnson

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CD38