BioCentury
ARTICLE | Clinical News

Darzalex combo meets PFS endpoint in first-line MM

December 14, 2018 8:59 PM UTC

Genmab A/S (CSE:GEN; Pink:GMXAY) and Janssen Biotech Inc. said Darzalex daratumumab plus Revlimid lenalidomide and dexamethasone met the primary endpoint of improving progression-free survival (PFS) in the Phase III MAIA trial to treat newly diagnosed multiple myeloma. Median PFS has not yet been reached in the Darzalex arm at a median follow-up of 28 months vs. 31.9 months for Revlimid and dexamethasone alone (HR=0.56, 95% CI: 0.43, 0.73, p<0.0001). Data were presented at the American Society of Hematology (ASH) meeting in San Diego.

The partners said the data will support a future sBLA to FDA for the Darzalex combo in the indication...

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