21 Dec Phase 3 Darzalex Trial Demonstrated Meaningful Improvement in Patients with Newly Diagnosed Multiple Myeloma
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The Phase 3 ALCYONE study data showed DARZALEX (daratumumab) in combination with bortezomib, melphalan, and prednisone (VMP) significantly improved clinical outcomes, including reducing the risk of disease progression or death by 50 percent, in newly diagnosed patients with multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT) at a median follow-up of 16.5 months (Hazard Ratio [HR] = 0.50; 95 percent CI [0.38-0.65], p<0.0001).
The median progression-free survival (PFS) for DARZALEX-VMP had not yet been reached, compared to an estimated median PFS of 18.1 months for patients who received VMP alone. In addition to reducing the risk of disease progression or death, DARZALEX significantly improved the overall response rate (ORR) as compared to VMP alone, including more than doubling rates of stringent complete response, significantly improved rates of very good partial response or better and complete response or better (CR).
The most common (≥10 percent) Grade 3/4 treatment-emergent adverse events (TEAEs) for DARZALEX-VMP vs. VMP were neutropenia (40 percent vs. 39 percent), thrombocytopenia (34 percent vs. 38 percent), anemia (16 percent vs. 20 percent) and pneumonia (11 percent vs. 4 percent). One patient in each arm discontinued treatment due to pneumonia, and 0.9 percent of patients discontinued DARZALEX due to an infection. Twenty-eight percent of patients experienced infusion reactions (IRs) due to DARZALEX.. In the DARZALEX-VMP arm, 42 percent of patients experienced a serious adverse event (SAE), compared to 33 percent in the VMP arm.
The study findings were as a late-breaking abstract (Abstract #LBA-4) at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, and simultaneously published in the New England Journal of Medicine (NEJM).
MedicalResearch.com: What should readers take away from your report?
Response: These Phase 3 results for DARZALEX demonstrated clinically meaningful improvements with a manageable safety profile for these patients. Selecting the right treatment regimen is critical for patients who are newly diagnosed, especially if they are transplant ineligible, as these patients tend to be older and more frail. These findings strongly support this DARZALEX frontline regimen as a new standard of care.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: On November 21, 2017 Janssen announced that is has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for DARZALEX. If approved, this would be the fifth indication for DARZALEX in the U.S. and its first in the frontline setting.
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Latebreaking ASH 2017 abstract
4 Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma Patients Ineligible for Transplant
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