RIO DE JANEIRO - Johnson & Johnson (NYSE: JNJ) announced today that DARZALEX FASPRO®, when used in combination with lenalidomide as a maintenance therapy, has shown to significantly improve minimal residual disease (MRD)-negativity rates in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant (ASCT). The findings come from the Phase 3 AURIGA study, which demonstrated that the combination more than doubled MRD-negativity rates at 12 months and improved 30-month progression-free survival (PFS) rates compared to lenalidomide alone.
The study's results, presented at the 2024 International Myeloma Society Annual Meeting, indicate a 50.5 percent MRD-negativity rate for the combination therapy versus 18.8 percent for lenalidomide alone. Moreover, the 30-month PFS rate was 82.7 percent for patients receiving DARZALEX FASPRO® plus lenalidomide, against 66.4 percent for those on lenalidomide maintenance alone.
Dr. Ashraf Badros, from the University of Maryland School of Medicine, noted the significant improvement in MRD-negativity conversion rates and the promising PFS data, suggesting that this regimen could potentially improve longer-term outcomes for transplant-eligible patients with NDMM.
Additionally, the AURIGA study showed that the D-R arm had higher complete response rates and a superior >6-month sustained MRD-negative rate compared to the R arm. Grade 3/4 treatment-related adverse events were reported in 74 percent of patients treated with D-R and 67.3 percent with R, with infections and neutropenia being the most common.
Further supporting data from the Phase 3 PERSEUS study and Phase 3 CASSIOPEIA study were also presented, indicating benefits of DARZALEX FASPRO®-based regimens across different patient populations and treatment phases.
DARZALEX FASPRO® is a subcutaneous formulation of daratumumab, a CD38-directed antibody, approved for multiple myeloma treatment in various settings. The AURIGA, PERSEUS, and CASSIOPEIA studies' safety profiles were consistent with known information for DARZALEX® and DARZALEX FASPRO®.
The results from these studies are based on a press release statement and have not been independently verified. They contribute to the growing body of evidence supporting the use of DARZALEX FASPRO® in the treatment of multiple myeloma.
In other recent news, Johnson & Johnson announced significant clinical advancements in multiple myeloma treatment. The Phase 3 CEPHEUS study demonstrated that DARZALEX FASPRO®, in combination with other drugs, improved patient outcomes. The Phase 1b RedirecTT-1 study also revealed promising efficacy for a novel bispecific antibody combination therapy in treating relapsed or refractory multiple myeloma. Furthermore, the TRIMM-2 study showed encouraging results with an overall response rate of 82 percent.
In legal developments, Johnson & Johnson's subsidiary, Red River Talc LLC, filed for a prepackaged Chapter 11 bankruptcy as part of an $8 billion settlement strategy to resolve ongoing ovarian cancer claims related to cosmetic talc litigation in the U.S. A new trial was ordered in Oregon in a case involving a $260 million verdict against Johnson & Johnson concerning claims that its talc powder caused mesothelioma.
In financial analysis, Goldman Sachs reiterated its Buy rating on shares of CG Oncology, following new data presented by Johnson & Johnson. Additionally, the company announced significant findings from their Phase 2 SKIPPirr study, indicating a substantial reduction in infusion-related reactions in patients with advanced non-small cell lung cancer. Lastly, Johnson & Johnson announced the retirement of D. S. Davis from its board of directors and the retirement of Executive Vice President and Chief Human Resources Officer, Dr. Peter M. Fasolo, with Kristen Mulholland named as his successor. These are recent developments at Johnson & Johnson.
InvestingPro Insights
Johnson & Johnson's latest breakthrough in multiple myeloma treatment with DARZALEX FASPRO® aligns well with the company's strong position in the pharmaceutical industry. According to InvestingPro data, J&J boasts a substantial market capitalization of $390.7 billion, underscoring its significant presence in the healthcare sector.
The company's financial health appears robust, with a revenue of $86.58 billion over the last twelve months as of Q2 2024, and a healthy revenue growth of 5.13% during the same period. This growth is particularly noteworthy given J&J's status as a mature company in the pharmaceutical industry.
An InvestingPro Tip highlights that J&J is a "Prominent player in the Pharmaceuticals industry," which is evident from its continued innovation in treatments like DARZALEX FASPRO®. This aligns with another InvestingPro Tip indicating that "Analysts predict the company will be profitable this year," suggesting that such breakthroughs contribute to J&J's financial success.
For investors considering J&J's stock, it's worth noting that the company has an attractive dividend yield of 3.07% and has raised its dividend for 53 consecutive years, as per another InvestingPro Tip. This demonstrates J&J's commitment to shareholder returns, which may be particularly appealing given the positive clinical results and potential market expansion for DARZALEX FASPRO®.
InvestingPro offers 11 additional tips for J&J, providing a more comprehensive analysis for those interested in delving deeper into the company's investment potential.
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