Johnson & Johnson's Darzalex Faspro Subcutaneous Formulation Demonstrates 37% Reduction in Death Risk in Phase 3 Myeloma Trial

Compiled by Fan Dongdong

Johnson & Johnson Presents Positive Data from Darzalex Myeloma Trial at the American Society of Hematology (ASH) Annual MeetingRecently, Johnson & Johnson announced positive data from a Darzalex myeloma trial at the American Society of Hematology (ASH) Annual Meeting. The trial results demonstrated that combining Darzalex Faspro with Celgene’s Pomalyst and the steroid dexamethasone slowed disease progression in multiple myeloma patients, reducing the risk of death by 37% compared to the combination of Pomalyst and dexamethasone alone.

In the Phase III APOLLO study, patients treated with Darzalex experienced a significant extension in survival time, with a median overall survival of 12.4 months without disease progression, compared to only 6.9 months for those receiving Pomalyst and the steroid dexamethasone alone. Furthermore, the Darzalex-based regimen prolonged the time to disease progression in patients refractory to Revlimid (9.9 months vs. 6.5 months). Compared with the doublet therapy, the Darzalex-based regimen yielded a complete response rate more than six times higher (25% vs. 4%) and a minimal residual disease (MRD) negativity rate four times higher (9% vs. 2%).

The positive results from the Apollo trial may lead to additional approved indications for Darzalex, such as in patients with relapsed or refractory disease. The active pharmaceutical ingredient of Darzalex is daratumumab, a monoclonal antibody targeting CD38. First approved in the United States in 2015 and in the European Union in 2016 as monotherapy for multiple myeloma, it became the first anti-CD38 monoclonal antibody approved worldwide for the treatment of multiple myeloma.

In May this year, the subcutaneous formulation of the drug, Darzalex Faspro, was approved for use in multiple treatment regimens for multiple myeloma, including for newly diagnosed patients, transplant-ineligible patients, and those with relapsed or refractory disease. Darzalex Faspro offers significant convenience in administration; as a fixed-dose formulation administered via subcutaneous injection, it can be delivered in approximately 3 to 5 minutes, whereas the intravenous formulation of Darzalex requires several hours for administration.

In November, Johnson & Johnson announced that it had submitted regulatory applications to the U.S. FDA and the European Medicines Agency (EMA), respectively, seeking approval for the subcutaneous (SC) formulation of Darzalex, in combination with pomalidomide and dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

Meanwhile, Darzalex Faspro is also seeking approval for new indications beyond the field of myeloma. At the American Society of Hematology Annual Meeting, trial data were presented for the drug in combination with Takeda’s Velcade, cyclophosphamide, and dexamethasone (VCd). The data showed that Darzalex Faspro cleared disease from the blood in 53% of patients with newly diagnosed light-chain amyloidosis (AL), compared to only 18% of patients who did not receive Darzalex.

Although light-chain amyloidosis is the most common type of amyloidosis, it remains a rare disease, with approximately 30,000 to 45,000 patients currently in the United States and Europe. In the United States, there are about 4,500 newly diagnosed cases of light-chain amyloidosis each year. These positive trial data support the FDA approval of Darzalex Faspro for this indication; if approved, the drug would become the first approved therapy.

Reference Source:

1.Johnson & Johnson shores up Darzalex's myeloma lead with another subcutaneous win

2.ASH 2020 Day 2 – Relapsed/Refractory Multiple Myeloma