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Genmab Announces Results In Phase III CASSIOPEIA Study Of Daratumumab

Genmab A/S (GMXAY.PK) announced the study met its primary endpoint for Part 1 of the Phase III CASSIOPEIA study (MMY3006) of daratumumab in combination with bortezomib, thalidomide and dexamethasone or VTD versus VTD alone as frontline treatment for patients who are candidates for autologous stem cell transplant (ASCT).

The first part of the study met the primary endpoint of number of patients that achieved a sCR, which was reported in 28.9% of patients treated with daratumumab in combination with VTD, compared to 20.3% of patients who received VTD alone with an odds ratio of 1.60 (95% CI: 1.21 - 2.12, p = 0.001). In the second part of the study, all responders have been re-randomized to receive either maintenance treatment with daratumumab monotherapy or observation (no treatment).

Overall, the safety profile of daratumumab in combination with VTD is consistent with the known safety profile of the VTD regimen used in patients receiving ASCT and the known safety profile for daratumumab.

Further analysis of the safety and efficacy data is ongoing and Janssen Biotech, Inc., which licensed daratumumab from Genmab in 2012, will discuss the potential for regulatory submissions for this indication with health authorities and IFM/HOVON plans to submit additional data for presentation at an upcoming medical conference and for publication in a peer-reviewed journal.

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