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DARZALEX® (daratumumab) subcutaneous formulation shows 51 percent reduction in risk of progression to active multiple myeloma for patients with high-risk smouldering multiple myeloma

December 9, 2024 – Clinical Trials – Johnson and Johnson Innovative Medicine, findings, multiple myeloma

First subcutaneous anti-CD38 therapy to demonstrate potential to prevent end-organ damage, and extend
progression-free survival and overall survival based on findings from Phase 3 AQUILA study

8 December 2024 – BEERSE, BELGIUM – Janssen-Cilag International NV, a Johnson & Johnson company, today announced data from the Phase 3 AQUILA study showing that DARZALEX® (daratumumab) subcutaneous (SC) formulation significantly delayed progression from high-risk smouldering multiple myeloma (SMM) to active multiple myeloma (MM) and extended overall survival compared to the current standard of care of active monitoring. The data were presented for the first time as an oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting (Abstract #773), taking place in San Diego, California, United States from 7-10 December, as part of the Press Programme and were selected for the Best of ASH session.

“Patients with high-risk smouldering multiple myeloma, which has no approved treatment, have a high probability of progressing to active multiple myeloma – a life-threatening stage of the disease,” said Meletios A. Dimopoulos, M.D., Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine and presenting author.* “Findings from AQUILA highlight the potential of early intervention with daratumumab SC to delay disease progression, extend overall survival and prevent end-organ damage associated with active multiple myeloma.”

In the AQUILA study, 194 patients received daratumumab SC and 196 patients were actively monitored per current standard of care treatment for high-risk SMM. At a median follow-up of 65.2 months (range, 0-76.6), patients who received daratumumab SC showed statistically significant improved progression-free survival (PFS; defined as progression to active MM, as assessed according to the International Myeloma Working Group diagnostic criteria for MM [SLiM-CRAB], or death) vs patients who underwent active monitoring; 63.1 percent in the daratumumab arm vs 40.8 percent in the active monitoring arm remained alive and progression-free at 60 months (Hazard Ratio [HR], 0.49; 95.0 percent Confidence Interval [CI], 0.36- 0.67; p<0.001). Amongst patients who were retrospectively categorised as having high-risk SMM, per the current Mayo 2018 criteria (20/2/20), median PFS was not reached in the daratumumab arm and was 22.1 months in the active monitoring arm (HR, 0.36; 95.0 percent CI, 0.23-0.58). Overall survival was also extended with daratumumab SC, with 5-year survival rates of 93.0 percent vs 86.9 percent for active monitoring (HR, 0.52; 95.0 percent CI, 0.27-0.98).

“Smouldering multiple myeloma represents a critical gap in care, with patients currently limited to treatment-free active monitoring upon diagnosis,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Hematology, Johnson & Johnson Innovative Medicine. “The AQUILA study offers a compelling case for shifting the treatment paradigm towards early disease interception for high-risk patients, showing treatment with fixed-duration daratumumab SC reduces end-organ damage and disease progression. These results underscore our commitment to addressing unmet needs and changing the way we manage multiple myeloma in its earliest stages.”

Additionally, patients who received daratumumab SC saw a higher overall response rate of 63.4 percent compared to 2.0 percent with active monitoring (p<0.001).1 Median time to first-line MM treatment was not reached for patients receiving daratumumab SC compared to 50.2 months with active monitoring (HR, 0.46; 95 percent CI, 0.33-0.62; nominal p<0.0001).

“We are encouraged by the findings from the AQUILA study, which may help to underscore the critical role of early disease intervention and potential to improve outcomes for patients with high-risk smouldering multiple myeloma,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.

“This proactive approach further highlights our goal of evolving the standard of care for patients at every stage of the disease.” Grade 3/4 treatment-emergent adverse events (TEAEs) occurred in 40.4 percent of patients treated with daratumumab SC and 30.1 percent of patients actively monitored. The most common (≥5 percent in either group) Grade 3/4 TEAE was hypertension (5.7 percent vs 4.6 percent, respectively). The frequency of TEAEs leading to discontinuation of daratumumab SC was low (5.7 percent), as was the incidence of fatal TEAEs in both groups (0.5 percent vs 2.0 percent, respectively). Last month, Johnson & Johnson submitted an Extension of Indication application to the European Medicines Agency and a supplemental Biologics License Application to the U.S. Food and Drug Administration for daratumumab SC and DARZALEX FASPRO®, respectively, for the treatment of adult patients with high-risk SMM based on the Phase 3 AQUILA data.

About Johnson & Johnson Innovative Medicine: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Visit: www.innovativemedicine.jnj.com/emea. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea.