▎WuXiEdited by Kant Content Team

Today, the American Society of Hematology (ASH) announced abstracts of some studies to be presented at the 2024 annual meeting. Among them, a product developed by Johnson & Johnson...Anti-CD38 Antibody Darzalex (Daratumumab) Meets Primary Endpoint in Phase 3 Clinical Trial Named Aquila, Significantly Delaying Disease Progression in High-Risk Smoldering Multiple Myeloma (SMM) Patients.

SMM is the pre-symptomatic stage of multiple myeloma (MM) and may progress to active multiple myeloma. Currently, there are no approved treatment options. However, recent studies show that patients at high risk of progression to MM may benefit from early treatment. Darzalex is a humanized monoclonal antibody targeting CD38, already approved for treating relapsed/refractory MM and used in combination with standard therapy as a first-line treatment for newly diagnosed MM patients. The Aquila study aims to determine whether Darzalex is more effective than active monitoring in delaying the progression of MM.

The abstract data shows,At a median follow-up of 65.2 months, Darzalex significantly improved progression-free survival (PFS, HR=0.49; 95% CI, 0.36-0.67; P<0.0001) compared to active monitoring. The median PFS in the Darzalex group has not yet been reached, while it was 41.5 months in the active monitoring group.; ExpectedThe 60-month progression-free survival rates were 63.1% and 40.8%, respectively.Preset analysis showed that the objective response rate (ORR) was 63.4% in the Darzalex group and only 2.0% in the active monitoring group (P<0.0001). As of the data cutoff date, 64 patients (33.0%) in the Darzalex group and 102 patients (52.0%) in the active monitoring group had started first-line MM treatment.

In the Darzalex group and the active monitoring group, the incidence rates of grade 3/4 treatment-emergent adverse events (TEAEs) were 40.4% and 30.1%, respectively. The most common grade 3/4 TEAE was hypertension (5.7% in the Darzalex group; 4.6% in the active monitoring group). The frequency of discontinuation due to TEAEs was low, and the incidence of fatal TEAEs was also low in both groups (1.0% in the Darzalex group; 2.0% in the active monitoring group).

The abstract points out that Darzalex monotherapy was well-tolerated and demonstrated statistically significant and clinically meaningful benefits in preventing or delaying the progression to active MM in patients with high-risk SMM compared to active monitoring.

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