Darzalex Faspro Combination Therapy Achieves 84.3% Progression-Free Survival Rate in Phase 3 PERSEUS Trial for Newly Diagnosed Multiple Myeloma

▎WuXi

Edited by Kant Content Team

Today, Johnson & Johnson and Genmab announced positive data from the PERSEUS Phase 3 clinical trial, which examined the efficacy and safety of their CD38 antibody Darzalex Faspro (daratumumab) in combination with standard therapy compared to standard therapy alone for the first-line treatment of newly diagnosed multiple myeloma patients. Analysis shows,Darzalex Faspro Combination Therapy Significantly Improves Patients' Progression-Free Survival (PFS).Detailed data were published in the abstract of the 2023 American Society of Hematology (ASH) Annual Meeting.

Analysis shows that at 47.5 months, the PFS of patients (n=355) receiving Darzalex Faspro in combination with standard therapy significantly improved compared to those (n=354) receiving standard therapy alone.Neither group reached the median PFS, but the hazard ratio for disease progression between the two groups was 0.42, with a p-value <0.0001, favoring the combination therapy.The estimated 48-month progression-free survival rate was 84.3% in the combination therapy group and 67.7% in the standard therapy group.Other secondary endpoints, including complete response rate and minimal residual disease (MRD) negativity, were also statistically significant, while overall survival data are not yet mature.

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PFS Analysis Results of the PERSEUS Trial (Image Source: Reference [1])

The safety profile was consistent with previous studies, with a higher number of treatment-related discontinuations occurring in patients receiving standard therapy. According to the industry media Endpoints,Johnson & Johnson and Genmab said they hope the data will support the therapy as a new standard of care for first-line treatment of multiple myeloma.

Darzalex Faspro was jointly developed by Janssen and Genmab,It is the first anti-CD38 antibody that can be administered via subcutaneous injection, reducing the treatment time for patients from several hours to just a few minutes.

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