IMW 2019: Daratumumab-Based Therapy Improves Response in Newly Diagnosed Myeloma
Posted: Thursday, September 19, 2019
Lenalidomide, bortezomib, and dexamethasone (RVd) plus the CD38 monoclonal antibody daratumumab induced higher response rates and greater depth of response, including stringent complete response and minimal residual disease negativity, than RVd alone, according to the results of the phase II GRIFFIN trial. The primary analysis of the randomized portion of this trial was presented at the 2019 International Myeloma Society’s 17th International Myeloma Workshop (IMW) in Boston (Abstract OAB-87).
Included in the GRIFFIN trial were 207 patients with autologous stem cell transplant (ASCT)-eligible newly diagnosed multiple myeloma. They were stratified by International Staging System (ISS) stage and creatinine clearance.
The study met its primary endpoint of stringent complete response rate by the end of consolidation, noted Peter Voorhees, MD, of Levine Cancer Institute, Charlotte, North Carolina, and colleagues. With the addition of daratumumab to RVd, the stringent complete response rate was 42.4% versus 32.0% with RVd alone (P = .1359) at the preset two-sided alpha of 0.2. The four-drug regimen yielded higher overall response (99% vs. 92%), at least very good partial response (91% vs. 73%), and at least complete response (52% vs. 42%) rates versus RVd. “And the rate of minimal residual disease negativity among patients achieving at least a complete response was higher with [daratumumab]-RVd (59% vs. 24%),” the investigators reported.
There was no difference in the rate of grade 3 or 4 infections between arms, nor new safety signals. The patients’ median age was 60 years; 48%, 37%, and 14% of patients had ISS stage I, II, and III disease, respectively. All patients received four induction cycles, stem cell mobilization, high-dose therapy, ASCT, two consolidation cycles, and maintenance with lenalidomide with and without daratumumab for 24 months.
Disclosure: The study authors’ disclosure information can be found at imw2019boston.org.
