J&J Reports Positive Phase 3 Results for Darzalex Faspro in Smouldering Multiple Myeloma

Johnson & Johnson (J&J) has unveiled promising results from a phase 3 clinical trial evaluating its subcutaneous CD38-directed antibody, Darzalex Faspro, for treating smouldering multiple myeloma (SMM). SMM is considered an early precursor of active multiple myeloma (MM), a more aggressive form of the disease. The findings were revealed at the American Society of Hematology (ASH) annual meeting and published in The New England Journal of Medicine.

In the United States, over 35,000 individuals are anticipated to receive a diagnosis of MM this year, with SMM cases making up 15% of these new diagnoses. Traditionally, SMM is not treated until it progresses to active MM. However, emerging evidence indicates that early therapeutic intervention could benefit patients with a high risk of progression to active MM.

The phase 3 AQUILA trial assessed Darzalex Faspro in 390 patients with high-risk SMM, comparing the drug to active monitoring. The study demonstrated significant improvements in progression-free survival. At a median follow-up of 65.2 months, 63.1% of patients treated with Darzalex Faspro remained progression-free at 60 months, significantly higher than the 40.8% in the active monitoring group.

For patients retrospectively identified as having high-risk SMM, median progression-free survival was not reached in those treated with Darzalex Faspro, in stark contrast to 22.1 months for those under active monitoring. The treatment also extended overall survival, with five-year survival rates of 93% compared to 86.9% in the active monitoring group. Additionally, the overall response rate for patients receiving Darzalex Faspro was 63.4%, compared to just 2% for those under observation.

These findings were announced shortly after J&J filed regulatory applications with both the European Medicines Agency and the US Food and Drug Administration. The applications seek approval for the use of Darzalex Faspro as a standalone treatment for adults with high-risk SMM, drawing on the data from the AQUILA trial.

Jordan Schecter, vice president and disease area leader for multiple myeloma at J&J Innovative Medicine, expressed optimism regarding the trial's findings. He noted that the study underscores the importance of early disease intervention and its potential to improve outcomes for patients with high-risk SMM.

The data from this study mark a significant advancement in understanding and potentially treating smouldering multiple myeloma. The promising results indicate that early intervention with Darzalex Faspro could alter the disease course for high-risk patients, potentially delaying progression to active multiple myeloma and improving overall survival rates. As the medical community continues to explore treatment options for SMM, J&J's findings provide a foundation for future therapeutic strategies and regulatory considerations.