Knowledge from the AQUILA research assist using fixed-duration subcutaneous Darzalex Faspro as an early remedy possibility in high-risk smoldering myeloma: © inventory.adobe.com.
A poster offered on the 2025 Society of Hematologic Oncology Annual Assembly confirmed that subcutaneous Darzalex Faspro (daratumumab and hyaluronidase-fihj) considerably lowered the chance of illness development or dying in contrast with lively monitoring in sufferers with high-risk smoldering a number of myeloma.
With a median follow-up of 65.2 months, the median progression-free survival (PFS) was not reached with Darzalex Faspro versus 41.5 months with monitoring, correlating with a 51% discount within the danger of progressive illness or dying. Per Worldwide Myeloma Working Group SLiM diagnostic standards, investigators famous development to a number of myeloma in 25.8% (50 of 194 sufferers) and 33.2% (65 of 196 sufferers) of every respective arm. Development to a number of myeloma occurred in 6.2% (12 of 194 sufferers) and 17.3% (34 of 196 sufferers) of sufferers in every arm.
Investigators highlighted a PFS profit with Darzalex Faspro throughout all pre-specified subgroups. An particularly pronounced profit occurred amongst sufferers with high-risk standing; the median PFS was not reached with Darzalex Faspro versus 22.1 months with monitoring on this group.
“Darzalex Faspro demonstrated a good security profile, with a low charge (5.7%) of remedy discontinuation because of treatment-emergent uncomfortable side effects. Sufferers maintained their health-related high quality of life throughout Darzalex Faspro remedy in contrast with lively monitoring,” lead research writer, Dr. Meletios Athanasios Dimopoulos, professor and chairman of the Division of Scientific Therapeutics on the Nationwide and Kapodistrian College of Athens Faculty of Medication in Greece, wrote within the poster with coauthors. “Outcomes from the part 3 AQUILA research strongly assist early intervention with subcutaneous Darzalex Faspro monotherapy for a set period in sufferers with high-risk smoldering a number of myeloma, representing a possibility to delay or keep away from end-organ injury and development to a number of myeloma though preserving high quality of life and increasing survival.”
Within the open-label, multicenter part 3 AQUILA research, 390 sufferers had been randomly assigned to obtain subcutaneous Darzalex Faspro at 1800 milligrams each week on cycles 1 and a pair of, each two weeks on cycles 3 to six, and each 4 weeks thereafter for a most of 36 months (194 sufferers) or lively monitoring, which consisted of no disease-specific remedy with aspect impact monitoring for as much as 36 months (196 sufferers). Through the research’s follow-up part, investigators evaluated efficacy till development and assessed survival each 6 months till the research’s conclusion.
The trial’s major finish level was impartial assessment committee. Key secondary finish factors included goal response charge (ORR), time to first-line remedy for a number of myeloma, PFS on first-line remedy, and total survival (OS).
Sufferers 18 years and older with a confirmed smoldering a number of myeloma analysis per Worldwide Myeloma Working Group standards for now not than 5 years, and an ECOG efficiency standing of 0 or 1 had been eligible for enrollment on the trial.
The median age was 63 years within the Darzalex Faspro arm and 64.5 years within the lively monitoring arm, and most from every respective arm had been girls (51% versus 52.6%). In every arm, most sufferers had an ECOG efficiency standing of 0 (85.1% versus 81.6%), fewer than thre danger elements for development to a number of myeloma (79.4% versus 79.6%), and intermediate-risk (39.7% versus 38.8%) or high-risk standing (37.1% versus 43.9%).
Knowledge confirmed an ORR of 63.4% with Darzalex Faspro versus 2% with lively monitoring. Amongst sufferers who obtained Darzalex Faspro, an excellent partial response or higher occurred in 29.9%, and eight.8% had a whole response or higher.
The median time to initiating subsequent frontline remedy was not reached within the Darzalex Faspro arm and 50.2 months within the monitoring arm. The 60-month PFS charge on frontline remedy was 85.9% and 78% in every respective arm. The 60-month OS charges had been 93% and 86.9%, respectively; information confirmed a powerful optimistic pattern towards longer OS with Darzalex Faspro.
Investigators famous no new security indicators amongst those that obtained Darzalex Faspro. Within the Darzalex Faspro and monitoring arms, 96.9% versus 82.7% had uncomfortable side effects of any grade, 40.4% versus 30.1% had grade 3 or larger uncomfortable side effects, 29% versus 19.4% had severe uncomfortable side effects, and 1% versus 2% had grade 5 uncomfortable side effects. The most typical grade 3 or larger aspect impact in every arm was hypertension (5.7% versus 4.6%), and the incidence of second major malignancies was comparable between arms (9.3% versus 10.2%).
Well being-related high quality of life outcomes with Darzalex Faspro gave the impression to be constant throughout a number of measures and domains. Comparable imply adjustments between baseline and week 112 occurred in each remedy arms.
The European Fee permitted subcutaneous Darzalex Faspro for this smoldering a number of myeloma inhabitants in July 2025 primarily based on findings from the AQUILA trial. Moreover, the FDA’s Oncologic Advisory Drug Committee voted in favor of Darzalex Faspro’s profit/danger profile for these with high-risk smoldering a number of myeloma in Might 2025.
References
- “Part 3 AQUILA research of daratumumab monotherapy versus lively monitoring in sufferers with high-risk smoldering a number of myeloma,” by Dr. Meletios Athanasios Dimopoulos. Introduced on the 2025 Society of Hematologic Oncology Annual Assembly (SOHO); Sept. 3-6, 2025; Houston, TX. MM-691.
- “European Fee approves DARZALEX (daratumumab) as the primary licensed remedy for sufferers with high-risk smouldering a number of myeloma,” by Johnson & Johnson. Information launch; July 23, 2025.
- “Might 20-21, 2025 Assembly of the Oncologic Medicine Advisory Committee (ODAC) – Day 1. Streamed stay Might 20, 2025,” by U.S. Meals and Drug Administration. https://www.youtube.com/stay/iSGFdhMgh1E
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