Multiple Myeloma

Until recently, patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation (ASCT), the multiagent regimen with lenalidomide (Revlimid) and dexamethasone was the standard of care. Results of the prespecified interim analysis of the MAIA trial demonstrated the benefit of adding daratumumab (Darzalex) to this combination therapy (Facon T, et al. N Engl J Med. 2019;380:2104-2115).

A dizzying array of new chimeric antigen receptor (CAR) T-cell therapies targeting the B-cell maturation antigen (BCMA) designed specifically for the treatment of multiple myeloma was presented at the 2018 American Society of Hematology (ASH) annual meeting. BCMA-targeted CAR T-cell therapies are designed to improve T-cell persistence, depth of response, and tolerability. Response rates reported at ASH 2018 range from 70% to 100%, depending on the patient population and the use of previous regimens.

San Diego, CA—In a first-in-human study of a novel bispecific T-cell engager (BiTE), AMG 420, when administered at a daily dose of 400 mcg, this novel drug induced responses in 7 of 10 patients with heavily pretreated multiple myeloma in a phase 1 clinical trial, according to results presented at ASH 2018.

San Diego, CA—Selinexor has shown promising activity in very heavily pretreated patients with penta-refractory multiple myeloma. In the pivotal STORM Part 2 study, oral selinexor in combination with low-dose dexamethasone induced responses in 26.2% of patients.

San Diego, CA—The results of a phase 2 clinical trial presented at ASH 2018 suggest that early therapeutic intervention is beneficial in patients with high-risk smoldering multiple myeloma.

San Diego, CA—A dizzying array of new chimeric antigen receptor (CAR) T-cell therapies targeting the B-cell maturation antigen (BCMA) designed specifically for the treatment of multiple myeloma was presented at ASH 2018. BCMA-targeted CAR T-cell therapies are designed to improve T-cell persistence, depth of response, and tolerability. Response rates reported at ASH 2018 range from 70% to 100%, depending on the patient population and the use of previous regimens.

San Diego, CA—Interim analysis of an international phase 3 clinical trial supports the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone as the new standard of care in patients with newly diagnosed multiple myeloma who are transplant-ineligible.

On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients with MM and is the first to be approved for the split-dosing regimen. This new regimen gives patients and healthcare providers the option to split the first dose of Darzalex over the course of 2 consecutive days, which has the benefit of shortening the duration of the first infusion.

San Diego, CA—In patients with multiple myeloma (MM), the use of drug therapy as maintenance has been shown to prolong the length of time the disease is controlled. Specifically, use of maintenance therapy may affect overall survival, particularly when it is used after an autologous stem-cell transplant (ASCT).