Multiple Myeloma

San Diego, CA—The addition of venetoclax (Venclexta) to bortezomib (Velcade) and dexamethasone yields high response rates in patients with relapsed or refractory multiple myeloma, especially in patients with disease that is not refractory to bortezomib and who received 1 to 3 previous lines of therapy, according to findings presented by Philippe Moreau, MD, Department of Hematology, Nantes University Hospital, France, at the 2016 American Society of Hematology meeting.

Interim results from a phase 1b study indicate that the investigational monoclonal antibody isatuximab, in combination with lenalidomide and dexamethasone, achieves responses in >50% of patients with relapsed or refractory multiple myeloma, including those with disease refractory to immunomodulatory drugs (IMiDs).

Adding the recently approved daratumumab (Darzalex), a human, CD38-directed monoclonal antibody, to a standard regimen of bortezomib (Velcade) and dexamethasone improved progression-free survival (PFS) by >60% compared with the standard regimen in patients with relapsed or refractory multiple myeloma, according to Antonio Palumbo, MD, Chief of the Multiple Myeloma Unit, University of Torino, Italy.

Daratumumab in combination with lenalidomide and dexamethasone achieved a 63% reduction in progression-free survival (PFS) compared with lenalidomide and dexamethasone alone in patients with multiple myeloma who had received at least 1 previous line of therapy, according to study results presented at the 2016 European Hematology Association Annual Congress meeting.

With the accelerated FDA approval in December 2015 of the anti-CD38 monoclonal antibody daratumumab (Darzalex) for patients with multiple myeloma who received ≥3 previous therapies, studies of the drug presented at ASH 2015 were of great interest.

The immunostimulatory monoclonal antibody elotuzumab (Empliciti), which was approved by the FDA in December 2015, is being studied in combination with immunomodulatory drugs and proteasome inhibitors in patients with relapsed or refractory multiple myeloma. Results presented at ASH 2015 show continued benefit from these regimens.

With the recent FDA approval of the first oral proteasome inhibitor ixazomib (Ninlaro), patients with relapsed or refractory multiple myeloma who have received previous treatment now have access to an all-oral regimen. The FDA-indicated triplet regimen of ixazomib, lenalidomide (Revlimid), and dexamethasone (Decadron) significantly improved progression-free survival (PFS) compared with the doublet of lenalidomide and dexamethasone, reported Philippe Moreau, MD, University of Nantes, France, at ASH 2015.

The year 2015 saw an explosion of new drugs approved by the FDA and new indications for drugs already on the market for multiple myeloma. Overall, 4 new drugs from 2 new classes were approved in 2015, changing the standard of care for patients with this disease.