Approval of a Darzalex Faspro therapy combo is sought in Europe

Treatment would address adults with eligible multiple myeloma conditions

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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Johnson & Johnson has applied to the European Medicines Agency (EMA) for approval of its under-the-skin formulation of Darzalex (daratumumab), called Darzalex Faspro (daratumumab and hyaluronidase-fihj), in combination with a standard triple-therapy regimen for treating adults with newly diagnosed multiple myeloma who are eligible for a stem cell transplant.

The application is supported by four-year data from the Phase 3 PERSEUS trial (NCT03710603), which enrolled 709 adults with newly diagnosed multiple myeloma who were eligible for a standard autologous stem cell transplant, according to a company press release.

Patients were treated with standard induction therapy (before transplant) and consolidation therapy (after transplant) with a combination of Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone, known as VRd. Maintenance therapy with Revlimid followed. Half of the patients also received Darzalex Faspro as an add-on to standard induction, consolidation, and maintenance therapies.

The PERSEUS study met its main goal, with the Darzalex Faspro combo group (D-VRd) showing a 58% lower risk of disease progression or death after a median follow-up of 47.5 months, or around four years.

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“The impressive results from the PERSEUS study highlight the potential of this daratumumab subcutaneous-based regimen to transform patient outcomes and provide an effective therapy option in newly diagnosed, transplant-eligible multiple myeloma,” said Craig Tendler, MD, vice president of clinical development, diagnostics, and global medical affairs at Johnson & Johnson Innovative Medicine, which markets Darzalex.

“We are committed to advancing innovative regimens, such as D-VRd, as we strive towards the elimination of this complex disease. We now look forward to working with the EMA on the review of this submission,” Tendler said.

Other findings from the trial

Darzalex is an antibody-based therapy targeting the surface protein CD38, which is found in high numbers in multiple myeloma cells. By binding to CD38, Darzalex causes myeloma cells to die.

In the U.S., Darzalex is approved either alone or as an add-on therapy for newly diagnosed or hard-to-treat myeloma patients. The under-the-skin (subcutaneous) formulation of Darzalex was designed to reduce treatment burden and side effects.

Additional data from PERSEUS showed that a higher proportion of patients treated with the Darzalex Faspro combo achieved complete responses or better (87.9% vs. 70.1%) and remained negative for minimal residual disease, or MRD (75.2% vs. 47.5%). In MRD, a number of cancer cells remain in a patient’s body after treatment, which can potentially cause disease relapse and progression.

A total of 64.8% of patients in the Darzalex Faspro group achieved sustained MRD-negativity for at least one year, compared with 29.7% of those on standard care.

The Darzalex Faspro combo appeared as safe as what was seen with Darzalex Faspro and the standard therapy regimen.

“Despite significant advances, multiple myeloma remains an incurable disease affecting more than 35,000 people each year in Europe alone,” said Edmond Chan, MD, therapeutic lead of hematology for the Europe, Middle East, and Africa region at Johnson & Johnson Innovative Medicine.

“We know response to first-line therapy is vital to improve patients’ long-term outcomes,” Chan said, “which is why we are proud of today’s submission and the potential of this daratumumab subcutaneous-based … therapy to achieve deep and durable responses in patients with newly diagnosed multiple myeloma.”