Janssen Announces China Approval of New Quadruplet Regimen with DARZALEX FASPRO® for Newly Diagnosed Multiple Myeloma Patients Eligible for Transplant

(Source: Shanghai Observer)

Johnson & Johnson announced today that its innovative therapeutic drug, Darzalex Faspro (subcutaneous injection), has officially received approval from the National Medical Products Administration to expand its indications. It will be used in combination with bortezomib, lenalidomide, and dexamethasone to treat newly diagnosed adult patients with multiple myeloma who are eligible for autologous stem cell transplantation. This means that patients at the newly diagnosed stage now have the opportunity to receive a four-drug combination regimen based on the subcutaneous injection formulation of daratumumab, providing a new treatment option that significantly improves prognosis.

This approval was based on the results of the Phase III PERSEUS study. The study compared two treatment regimens in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation: a four-drug combination regimen (DVRd) based on subcutaneous injection of daratumumab for induction and consolidation therapy, followed by maintenance therapy with subcutaneous injection of daratumumab in combination with lenalidomide; and induction and consolidation therapy with bortezomib, lenalidomide, and dexamethasone (VRd), followed by maintenance therapy with lenalidomide.

Research data with a median follow-up of 47.5 months showed a significant improvement in the primary endpoint, progression-free survival (PFS). Compared with the VRd regimen, the DVRd regimen reduced the risk of disease progression or death by 58%. In terms of depth of response, the DVRd regimen also demonstrated significant advantages: the overall minimal residual disease (MRD) negativity rate (detection sensitivity 10⁻⁵) reached 75.2%, higher than 47.5% in the VRd group (p < 0.0001); 87.9% of patients achieved complete response or better, higher than 70.1% in the VRd group (p < 0.0001); importantly, the proportion of patients achieving sustained MRD negativity for ≥12 months was 64.8%, significantly higher than 29.7% in the VRd group.

President of Johnson & Johnson Innovative Medicine China, Huang Chen, stated: "The treatment regimen approved this time brings significant clinical benefits to newly diagnosed multiple myeloma patients, reaffirming our commitment to bring transformative solutions to more frontline treatment patients. At the same time, we hope that the new treatment regimen based on the subcutaneous injection formulation of daratumumab will continue to improve treatment outcomes and establish a new standard of care. At Johnson & Johnson, we are always committed to helping multiple myeloma patients achieve functional cures, and the important progress made today is a crucial step toward this goal. We promise to continuously build an end-to-end patient health management system – from early screening, innovative treatments, to long-term management – safeguarding the full-cycle health of patients, so that innovative results not only treat diseases but also heal the body and mind."

Patients with multiple myeloma exhibit significant variability in clinical manifestations, and frontline treatment is the critical phase for achieving the deepest remission and prolonged survival. There is an urgent need for innovative therapies that can significantly delay disease progression. With robust evidence, a quadruplet regimen based on the subcutaneous formulation of daratumumab offers a transformative new option for clinical practice, demonstrating potential to enhance remission depth and extend the duration of response among patients eligible for autologous stem cell transplantation.

The overall safety profile of the DVRd regimen is consistent with the known safety characteristics of daratumumab subcutaneous injection formulation and the VRd regimen. The most common hematological adverse reactions (incidence rate ≥20%) include neutropenia, thrombocytopenia, and anemia. The most common non-hematological adverse reactions include peripheral neuropathy, fatigue, peripheral edema, fever, upper respiratory tract infection, SARS-CoV-2 infection, constipation, diarrhea, back pain, insomnia, asthenia, and rash.

Original Title: "Johnson & Johnson Announces Approval of New Four-Drug Combination Regimen for DARZALEX FASPRO in China, Bringing Benefits to Newly Diagnosed Multiple Myeloma Patients"

Editor-in-Chief: Rong Bing, Source of Title Image: Shanghai View Title Image

Source: Author: Tang Weijie, Wen Hui Bao