Addition of Darzalex™ Improves Outcomes in Newly Diagnosed Multiple Myeloma

Addition of Darzalex™ to either Revlimd or Velcade based treatment regimens delays recurrence and prolongs survival.

Adding Darzalex to Standard Myeloma Regimens Improves Treatment Outcomes

by Dr. C.H. Weaver M.D. updated 11/5/2018

The standard treatment of newly diagnosed multiple myeloma consists of systemic treatment regimes using combinations of chemotherapy, immunotherapy and precision cancer medicines followed by high dose chemotherapy and autologous stem cell transplant (ASCT). Many patients however are ineligible or unable to undergo ASCT and are treated with systemic therapy alone.

Research studies suggest that the addition of Darzalex (daratumumab) to standard systemic treatment regimens further improves survival and delays the time to cancer progression.

About Darzalex™ (daratumumab)

Darzalex™ is a monoclonal antibody that has been produced in a laboratory to bind to a protein often found on the surface of multiple myeloma cancer cells, called CD38. The binding of Darzalex™ has direct killing effects on the myeloma cells, as well as stimulating the immune system to attack the cancer cells. Darzalex™ is approved for the treatment of multiple myeloma in combinations with different types of treatment regimens among patients whose cancer has progressed following therapy and based on the studies below also provides substantial benefit as initial treatment.

Addition of Darzalex to Revlimid (lenalidomide) and Dexamethasone

The Phase III MAIA clinical study enrolled 737 newly diagnosed patients with multiple myeloma who were not candidates for high dose chemotherapy and ASCT to receive treatment with Revlimid and dexamethasone with or without Darzalex and directly compared.

The study was designed to assess the time to myeloma progression and is reported to demonstrate a 45% reduction in myeloma progression or death for Darzalex treated patients. On average Revlimid/Dexamethasone treated patients survived ~32 months without myeloma progression. Darzalex/Revlimid/Dexamethasone treated patients survive beyond 32 months with an average survival time not yet reached.

Addition of Darzalex™ to Velcade (bortezomib), Melphalan, and Prednisone (VMP)

Darzalex plus VMP reduces disease progression or death by 50%, among patients with newly diagnosed multiple myeloma who are not eligible to undergo a stem cell transplant.

Researchers have reported the results of a clinical trial designed to evaluate the addition of Darzalex™ to VMP among patients who had not yet received prior treatment, and were not eligible for a stem cell transplant. Patients in the trial were at least 65 years of age and were divided into two groups: one group was treated with Darzalex™ plus VMP (D-VMP), and the other group was treated with VMP only. Data was retrieved at a median follow-up of 16.5 months following initiation of treatment.

  • Patients treated with D-VMP had a 50% reduction in their risk of death or disease progression, compared to those treated with VMP only.
  • Treatment benefit of D-VMP remained among all treatment groups: for patients 75 years of age and older; for patients with later-stage multiple myeloma; and for patients whose genetic analysis determined that they were at a high risk for a cancer recurrence.
  • At this time, overall survival data are too immature to determine true overall survival differences between the two groups of patients.

The addition of Darzalex™ to VMP or Revlimid/Dexamethasone for the treatment of newly diagnosed ASCT ineligilble multiple myeloma patients significantly reduces their risk of death or disease progression and represents an effective treatment option.

Reference:

  1. https://ir.genmab.com/news-releases/news-release-details/genmab-announces-positive-topline-results-phase-iii-maia-study
  2. Mateos M-V, Dimopoulos M, Cavo M, et al. Phase 3 randomized study of Darzalex™ plus bortezomib, melphalan, and prednisone (D-VMP) versus bortezomib, melphalan, and prednisone (VMP) in newly diagnosed multiple myeloma (NDMM) patients (pts) ineligible for transplant (ALCYONE). Proceedings from the 59th annual meeting and exhibition of the American Society of Hematology; Atlanta, GA; December 9-12, 2017; Late-breaking abstract #4. Retrieved from

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