Adding Darzalex to Standard of Care May Improve Survival in Newly Diagnosed Multiple Myeloma

Results from a recent study strongly support a treatment regimen of Darzalex with Revlimid and dexamethasone as a new standard of care for patients with transplant-ineligible newly diagnosed multiple myeloma.

After almost five years of follow-up, the addition of Darzalex (daratumumab) to Revlimid (lenalidomide) and dexamethasone reduced the risk of death by 32%, compared with dexamethasone alone in patients with newly diagnosed multiple myeloma who are transplant ineligible, according to updated data from the MAIA trial presented at the 2021 European Hematology Association annual meeting.

“These results strongly support upfront (Darzalex) with (Revlimid) and dexmathasone as a new standard of care for patients with transplant-ineligible newly diagnosed multiple myeloma,” Dr. Thierry Facon, professor of hematology in the Department of Hematology at Lille University Hospital in France, said during a presentation of the data. Currently, the standard of care for this patient population is Revlimid and dexamethasone.

The estimated five-year overall survival (the length of time that a patient is alive after diagnosis or treatment; OS) rate was 66.3% in the Darzalex, Revlimid and dexamethasone group compared with 53.1% in the Revlimid plus dexamethasone group, “which will likely lead to a substantial improvement in median OS in this patient population,” Facon said.

Facon noted that the significant progression-free survival (the length of time during and after treatment of a disease that the patient lives without recurrence; PFS) benefit of Darzalex, Revlimid and dexamethasone compared with Revlimid plus dexamethasone was maintained, with a 47% reduction in the risk for disease progression or death. Median PFS was not reached with the addition of Darzalex, compared with 34.4 months with Revlimid plus dexamethasone.

The estimated five-year PFS rate was 52.5% with Darzalex, Revlimid and dexamethasone, compared with 28.7% with Revlimid plus dexamethasone. “These data provide a new PFS benchmark in patients with newly diagnosed multiple myeloma who are transplant ineligible,” Facon explained.

Also of note, Facon added, these PFS and OS results were achieved in a patients aged 75 to 90 years.

In the MAIA trial, the researchers enrolled 737 patients (median age, 73 years) with newly diagnosed multiple myeloma who were ineligible for autologous stem-cell transplantation (ASCT) to receive either Darzalex plus Revlimid and dexamethasone or Revlimid and dexamethasone (standard of care), alone, until disease progression or unacceptable side effects.

PFS served as the major focus of the study, with other areas including OS, PFS2 (time from enrollment to second disease progression or death), overall response rate, compete response (the disappearance of all target lesions, CR) and stringent CR and minimal residual disease.

Patients were enrolled in the trial from March 2015 to January 2017.

The overall response rate was 92.9% in patients assigned Darzalex plus Revlimid and dexamethasone compared with 81.6% in those assigned standard of care.

Lastly, there were no new safety signals observed with continuous therapy and follow-up. The most common serious or life-threatening side effects in patients assigned Darzalex plus Revlimid and dexamethasone or those assigned standard of care included low neutrophil counts (54.1% versus 37%, respectively), pneumonia (19.2% versus 10.7%), anemia (16.8% versus 21.6%) and low levels of lymphocytes (16.5% versus 11.2%).

Of note, a lower percentage of serious treatment-related side effects occurred after 24 months, compared with the first 24 months, in both treatment groups.

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