Dr Yee on Daratumumab/Lenalidomide With Ixazomib/Dexamethasone in Multiple Myeloma

“[We saw] high overall response rates which translated to a [12-month] PFS [rate] of 92.4%.”

Andrew Yee, MD, the clinical director of the Center for Multiple Myeloma at Massachusetts General Hospital and an assistant professor of medicine at Harvard Medical School, discussed findings from a phase 2 study (NCT04009109) of lenalidomide (Revlimid) plus ixazomib (Ninlaro),​dexamethasone, and daratumumab (Darzalex) for the treatment of patients with newly diagnosed multiple myeloma, which were presented during the 22nd Annual International Myeloma Society Meeting and Exposition.

The intended patient population of the phase 2 study was approximately 188 patients, but accrual was affected by the COVID-19 pandemic, Yee began. The study was able to enroll 79 patients, all of whom received the same treatment regimen of 12 cycles of daratumumab at 1800 mg via a conventional schedule, lenalidomide at 15 mg on days 1 through 21, ixazomib at 4 mg on days 1, 8, and 15, and weekly dexamethasone, he continued. After 1 year, patients were randomly assigned to maintenance therapy with lenalidomide or daratumumab plus lenalidomide and ixazomib, he added. The primary end point was progression-free survival (PFS), he noted.

Following 1 year of treatment, patients (n = 79) achieved an overall response rate of 92.4% (95% CI, 84.2%-97.2%), Yee said. The very good partial response (VGPR) or better and complete response (CR) or better rates were 69.6% (95% CI, 58.3%-79.5%) and 22.8% (95% CI, 14.1%-33.6%), respectively. The CR and VGPR rates were 15.2% and 46.8%, respectively. Three patients achieved a stringent CR and 18 experienced a partial response.

Additionally, the high response rate translated into a 12-month PFS rate of 92% (95% CI, 86.1%-98.4%), Yee said, noting that this finding was similar to that of standard-of-care approaches with significantly lower rates of neutropenia.

Yee concluded that these findings show that the regimen can be adapted for use in older, more frail patients to make for a more favorable patient experience, without compromising efficacy.