Multiple myeloma regulatory updates (June 2019)

Daratumumab in combination with bortezomib, thalidomide and dexamethasone (D-VTd)

The United States (U.S.) Food & Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for D-VTd in patients with transplant eligible, newly diagnosed multiple myeloma (NDMM).¹ Results from the phase III CASSIOPEIA trial, recently presented during the American Society of Clinical Oncology (ASCO) meeting in Chicago, US, showed a clinical benefit of D-VTd compared to the traditional triplet, VTd, alone. A stringent complete response (sCR) rate of 28.9% was reported in patients treated with D-VTd compared to 20.3% with VTd. Rates of minimal residual disease (MRD) negativity (10^-5) were also higher in the D-VTd arm at 63.7% compared to 43.5% in the VTd arm. The regimen had a manageable safety profile. Overall survival data is immature.²

Read the breakdown of the CASSIOPEIA results here.

ALLO-715: allogeneic CAR T-cell product

Allogeneic CAR T-cell therapy has taken another step forwards with the U.S. FDA granting ALLO-715 an Investigational New Drug (IND) application. The phase I UNIVERSAL study will use ALLO-715, an anti B-cell maturation antigen (BCMA)-targeting allogeneic CAR T-cell therapy, in patients with relapsed/refractory multiple myeloma (RRMM).^3,4

Read more about allogeneic CAR T-cell therapy here.

Venetoclax partial hold lifted by the U.S. FDA for CANOVA trial

On 24 June 2019 the U.S. FDA removed the partial hold that had been placed on the phase III CANOVA trial (NCT03539744) which is comparing venetoclax + dexamethasone to pomalidomide + dexamethasone in patients with RRMM who have the t(11;14) genetic abnormality. This trial protocol has been adapted with risk mitigation measures in place. Enrollment in the CANOVA trial will now continue, despite other trials using venetoclax in multiple myeloma remaining on hold.^5-6

Read more about the BELLINI trial here; the results of which prompted the FDA hold.