FDA approves dara-VTd for transplant eligible, newly diagnosed multiple myeloma

The United States (US) Food & Drug Administration (FDA) have approved the use of daratumumab (dara), in combination with bortezomib (V), thalidomide (T) and dexamethasone (dara-VTd) for the treatment of transplant eligible patients with newly diagnosed multiple myeloma (NDMM). The approval is based on part one of the CASSIOPEIA trial results which were presented earlier this year at the American Society of Clinical Oncology (ASCO) meeting by Professor Philippe Moreau, and were simultaneously published in The Lancet.¹

CASSIOPEIA, part one²

Data given as dara-VTd versus VTd

In the phase III CASSIOPEIA trial, patients received either dara-VTd (n= 543) or VTd (n= 542) as induction therapy, followed by autologous stem cell transplant (ASCT) and consolidation with dara-VTd or VTd alone.

In part one of the trial, the primary endpoint was post-consolidation stringent complete response (sCR).³ sCR was improved in the dara-VTd arm (29% vs 20%, odds ratio: 1.6, p= 0.001). Additionally, dara-VTd provided higher rates of measurable residual disease (MRD)-negativity at the rate of 10^-5 (64% vs 44%, p< 0.0001). Eighteen-month progression-free survival (PFS) was also improved with dara-VTd (93% vs 85%, hazard ratio: 0.47, p< 0.0001) and median overall survival (OS) was not reached in either arm.

To read these results in more detail, click here.

CASSIOPEIA, part two^1,3

Patients who achieve a response to induction and consolidation will subsequently be re-randomized to maintenance therapy with daratumumab (16mg/kg every eight weeks for up to two years) or observation. The primary endpoint of part two is post-maintenance PFS.^1,2