RIO DE JANEIRO - Johnson & Johnson (NYSE:JNJ) has announced significant clinical improvements in the treatment of newly diagnosed multiple myeloma patients who are ineligible for transplant. The findings from the Phase 3 CEPHEUS study, presented at the International Myeloma Society Annual Meeting, demonstrate that DARZALEX FASPRO®, when used in combination with other drugs, improves patient outcomes.
The CEPHEUS study compared the efficacy and safety of DARZALEX FASPRO® combined with bortezomib, lenalidomide, and dexamethasone (D-VRd) against a regimen without DARZALEX FASPRO® (VRd). The study met its primary endpoint, with a 60.9 percent MRD-negativity rate for D-VRd compared to 39.4 percent for VRd. Additionally, D-VRd significantly reduced the risk of disease progression or death by 43 percent compared to VRd.
The trial enrolled 396 patients across 13 countries and has been ongoing for a median of 58.7 months. The results show that the D-VRd regimen nearly doubled the proportion of patients achieving sustained MRD-negativity of at least 12 months compared to VRd. The median progression-free survival (PFS) for D-VRd has not been reached, indicating potential long-term benefits, whereas it was 52.6 months for VRd.
Dr. Saad Z. Usmani of the Memorial Sloan Kettering Cancer Center highlighted the clinical importance of the study, noting the strong predictor of improved long-term outcomes associated with MRD negativity. He emphasized the potential of the DARZALEX FASPRO®-based quadruplet to become a new standard in this treatment setting.
The safety profile of D-VRd was consistent with the known safety profiles of its components. Common adverse events included neutropenia, thrombocytopenia, anemia, peripheral neuropathies, diarrhea, and COVID-19.
Johnson & Johnson's Global Head of Oncology, Dr. Robin Carson, expressed optimism about the potential of DARZALEX FASPRO®-based quadruplet regimen to serve as a foundational frontline therapy across all patient types during first-line treatment.
The study's findings are based on a press release statement and add to the growing body of evidence supporting the use of DARZALEX FASPRO® in multiple myeloma treatment.
In other recent news, Johnson & Johnson has reported promising results from its Phase 1b RedirecTT-1 study and TRIMM-2 study, both focused on treating relapsed or refractory multiple myeloma. The results indicate high overall response rates and manageable safety profiles for the combination therapies being tested. In legal developments, the company's subsidiary, Red River Talc LLC, has 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. Furthermore, an Oregon judge has ordered a new trial in a case involving a $260 million verdict against Johnson & Johnson concerning claims that its talc powder caused mesothelioma. Goldman Sachs has reiterated its Buy rating on shares of CG Oncology, following new data presented by Johnson & Johnson. The company also 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 recent clinical success with DARZALEX FASPRO® aligns well with its strong market position and financial health. According to InvestingPro data, the company boasts a substantial market capitalization of $390.74 billion, underlining its significant presence in the pharmaceutical industry.
An InvestingPro Tip highlights that J&J is a "prominent player in the Pharmaceuticals industry," which is evident from its innovative treatments like DARZALEX FASPRO®. This market leadership is further supported by the company's robust financials, with a reported revenue of $86.58 billion over the last twelve months as of Q2 2024.
Another relevant InvestingPro Tip notes that J&J "has maintained dividend payments for 54 consecutive years." This impressive track record of consistent dividends, coupled with a current dividend yield of 3.07%, showcases the company's financial stability and commitment to shareholder returns. This could be particularly appealing to investors looking for both growth potential from innovative treatments and steady income.
The company's strong financial position is also reflected in its profitability. J&J reported a gross profit of $60.11 billion over the last twelve months, with a healthy gross profit margin of 69.43%. This financial strength provides the company with the resources to continue investing in groundbreaking research and development, such as the CEPHEUS study.
For investors interested in a deeper analysis, InvestingPro offers 11 additional tips for Johnson & Johnson, providing a comprehensive view of the company's financial health and market position.
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