RARITAN, N.J. - Johnson & Johnson (NYSE:JNJ) has disclosed positive outcomes from the Phase 3 CARTITUDE-4 study, which revealed a significant improvement in overall survival for patients with relapsed or lenalidomide-refractory multiple myeloma treated with CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) compared to standard therapies.
The trial evaluated CARVYKTI® against pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (DPd) in patients after one prior line of therapy.
The study's interim analysis indicated that CARVYKTI®, a one-time infusion and BCMA-targeted CAR-T cell therapy, significantly enhanced patient survival compared to the standard treatments. Safety data from the analysis were consistent with the therapy's approved label.
Dr. Jordan Schecter, Vice President at Johnson & Johnson, expressed enthusiasm for the results, highlighting the therapy's potential to change outcomes for individuals living with multiple myeloma.
CARVYKTI® was initially approved by the U.S. FDA in February 2022 for adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy. Subsequent approvals expanded its indication to patients with at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and who are refractory to lenalidomide.
The CARTITUDE-4 study, which compares CARVYKTI® to standard care, aims to evaluate its efficacy and safety, with progression-free survival as the primary endpoint. The therapy works by reprogramming a patient's T-cells to target BCMA-expressing cells, a common feature in malignant multiple myeloma cells.
Multiple myeloma is a type of blood cancer that affects plasma cells in the bone marrow, leading to rapid proliferation and spread of these cells, replacing normal bone marrow cells with tumors. In 2024, it is estimated that more than 35,000 people will be diagnosed with the disease in the U.S., and over 12,000 may die from it.
Johnson & Johnson plans to present updated results from the CARTITUDE-4 study at an upcoming medical meeting and submit them to regulatory authorities worldwide.
The information provided is based on a press release statement from the company.
In other recent news, Johnson & Johnson (J&J) has been at the center of several significant developments. Despite a global slowdown in mergers and acquisitions, J&J has been involved in substantial deals, including a $13 billion purchase of Shockwave Medical (NASDAQ:SWAV). However, legal challenges have also been prominent, with a Supreme Court directive to reassess a lawsuit involving J&J and other pharmaceutical companies over the alleged facilitation of terrorism.
The company is also facing a proposed class action demanding medical monitoring for women who may develop cancer due to the use of its talc-based products. Furthermore, J&J has submitted a Biologics License Application to the FDA for a new cancer treatment, amivantamab, following promising results from the Phase 3 PALOMA-3 study.
Additionally, J&J presented long-term data from its MonumenTAL-1 study, indicating the effectiveness of its multiple myeloma treatment, TALVEY®. On the analyst front, RBC (TSX:RY) Capital maintained an Outperform rating on J&J, while Citi adjusted its price target for the company to $180, maintaining a 'Buy' rating.
These are some of the recent developments concerning Johnson & Johnson.
InvestingPro Insights
As Johnson & Johnson (NYSE:JNJ) continues to make strides in the treatment of multiple myeloma with their CARVYKTI® therapy, the financial health of the company remains a critical factor for investors monitoring the stock. Johnson & Johnson's market capitalization stands robust at $352.43 billion, reflecting the company's substantial size and stability within the pharmaceutical industry. The company's current P/E ratio is 9.43, which may suggest that the stock is undervalued relative to its earnings.
InvestingPro Tips highlight Johnson & Johnson's long-standing commitment to shareholder returns, with a remarkable track record of raising its dividend for 53 consecutive years. This could be a reassuring signal for income-focused investors, especially when considering the company's solid dividend yield of 3.39% as of the latest data. Moreover, Johnson & Johnson's low price volatility could appeal to investors seeking a more stable equity holding in their portfolios.
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