Multiple Myeloma

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.

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).

The 3-drug regimen should be considered a new standard of care. The 61% improvement in PFS is “unprecedented in randomized studies that compare novel treatments for relapsed or refractory multiple myeloma,” reported Antonio Palumbo, MD.
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.
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 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.
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.
Monoclonal antibodies may be to multiple myeloma what rituximab has been to lymphoma, according to myeloma experts who expressed enthusiasm over these emerging agents at an education session at ASH 2014.
Pomalidomide plus low-dose dexamethasone is “likely to be a cost-effective use of healthcare resources,” according to researchers from the United Kingdom, who presented a pharmacoeconomic analysis at ASH 2014.
The weekly administration of carfilzomib may be equivalent to the current practice of twice-weekly injections, according to an abstract presented at ASH 2014 by Antonio Palumbo, MD, of the University of Turin, Italy, and colleagues.
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