Applications submitted in the U.S. and EU seeking approval of Darzalex Faspro / Darzalex as subcutaneous monotherapy for high-risk smoldering multiple myeloma

The applications are supported by data from the ongoing Phase III AQUILA study (NCT03301220) of Darzalex Faspro as monotherapy for the treatment of adult patients with high-risk smoldering multiple myeloma.

Smoldering multiple myeloma is an early precursor of active multiple myeloma, where abnormal cells can be detected in the bone marrow, but patients are typically asymptomatic. Fifteen percent of all cases of newly diagnosed multiple myeloma are classified as smoldering multiple myeloma, and half of those diagnosed with high-risk disease will progress to active multiple myeloma within two years. Currently, smoldering multiple myeloma is not generally treated until active multiple myeloma develops. Instead, the standard approach is observation to track the disease for signs of biochemical progression and/or end organ damage, when treatment tends to be initiated. Recent evidence suggests that those at high-risk for progression to active multiple myeloma could benefit from earlier therapeutic intervention.

“There remains an unmet need for early interventions and treatments that are both effective and well tolerated in people living with smoldering multiple myeloma at high-risk of progressing to active multiple myeloma,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D. Global Therapeutic Area Head, Oncology, Innovative Medicine, Johnson & Johnson. “Darzalex has changed the standard of care in multiple myeloma, and with these submissions to the FDA and EMA, this therapy could become the first approved treatment for patients with high-risk smoldering multiple myeloma, potentially shifting the treatment paradigm.”

The first data from the AQUILA study, evaluating the safety and efficacy of Darzalex Faspro  compared to active monitoring in participants with high-risk smoldering multiple myeloma, will be presented at the 2024 American Society of Hematology (ASH) Annual Meeting, taking place in San Diego from December 7-10.

About the AQUILA Study; AQUILA (NCT03301220) is a randomized, multicenter Phase III study investigating Darzalex Faspro versus active monitoring in patients (n=390) with high-risk smoldering multiple myeloma. The primary endpoint is progression free survival and secondary endpoints include time to progression, overall response rate and overall survival. Patients in the study were diagnosed with smoldering multiple myeloma in the last five years and were excluded if they had prior exposure to approved or investigational treatments for smoldering multiple myeloma or multiple myeloma.

About Smoldering Multiple Myeloma; Smoldering multiple myeloma is an asymptomatic precursor state to multiple myeloma. Patients with smoldering multiple myeloma have higher levels of abnormal plasma cells in the bone marrow and an elevated monoclonal protein (M-protein) level in the blood, but they do not yet exhibit the symptoms commonly associated with active multiple myeloma, particularly end-organ damage. Fifteen percent of all cases of newly diagnosed multiple myeloma are classified as smoldering multiple myeloma, and half of those diagnosed with high-risk disease will progress to active multiple myeloma within two years.

About DARZALEX FASPRO and DARZALEX
Darzalex Faspro (daratumumab and hyaluronidase-fihj) received  FDA approval in May 2020 and is approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible. It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. Darzalex Faspro is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s Enhanze  drug delivery technology. Darzalex  (daratumumab) received FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant-eligible and ineligible. Darzalex s the first CD38-directed antibody approved to treat multiple myeloma. Darzalex -based regimens have been used in the treatment of more than 518,000 patients worldwide and more than 68,000 patients in the U.S. alone. In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.