J&J Shares Rise on 'Unprecedented' Myeloma Drug Combo Data
Phase 3 trial shows an 83% reduction in disease progression, positioning TECVAYLI-DARZALEX duo as a new standard of care.
Johnson & Johnson (NYSE: JNJ) shares gained ground Tuesday after the healthcare giant unveiled what it called “unprecedented results” from a late-stage study of its combination therapy for multiple myeloma, a common type of blood cancer. The data reinforces the company's dominant position in oncology and points to a potential new standard of care for patients.
In Tuesday morning trading, Johnson & Johnson shares climbed 0.86% to $203.42, adding to the momentum of a company with a market capitalization of approximately $486.5 billion. The gains came after the company announced its Phase 3 MajesTEC-3 study showed a combination of its drugs TECVAYLI (teclistamab) and DARZALEX (daratumumab) dramatically improved outcomes for patients with relapsed or refractory multiple myeloma.
The study found that the combination therapy reduced the risk of disease progression or death by 83.4% compared to current standard-of-care regimens. According to the company's press release, the results were statistically significant and clinically meaningful, prompting a U.S. Food and Drug Administration (FDA) review under its Real-Time Oncology Review program, which is designed to expedite the delivery of safe and effective cancer treatments.
“With these data, we are entering a new era in treating multiple myeloma with the first immunotherapy combination to demonstrate superior overall survival as early as second line versus standard of care,” said Sen Zhuang, M.D., Ph.D., Vice President of Oncology Clinical Research at Johnson & Johnson Innovative Medicine. The combination has already received a Breakthrough Therapy Designation from the FDA.
The data showed a significant improvement in overall survival, with 83.3% of patients on the combination therapy alive at the three-year mark, compared to 65% for those on standard regimens. This strong survival benefit is a critical metric for both clinicians and investors, signaling a high likelihood of regulatory approval and rapid adoption in the market.
Dr. Maria-Victoria Mateos, a consultant physician in hematology at the University Hospital of Salamanca and the study's lead investigator, highlighted the treatment's potential. “The combination of teclistamab and daratumumab SC offers remarkable efficacy and safety... and has the potential to change the standard of care as a steroid-sparing combination regimen suited for outpatient administration,” she noted.
This success is a key development in Johnson & Johnson's broader oncology strategy, particularly within its multiple myeloma franchise. DARZALEX is already a blockbuster drug, and combining it with the newer bispecific antibody TECVAYLI could extend its market leadership. The results position J&J to compete effectively in a crowded but lucrative market, cementing its status as a leader in blood cancer therapies. Analysts have noted J&J's ambition to achieve functional cures in multiple myeloma, and this data is a significant step in that direction.
The company's pipeline includes other promising treatments like CARVYKTI, a CAR-T therapy that has also shown durable remissions in earlier treatment lines. This multi-pronged approach, combining different mechanisms of action, showcases a sophisticated strategy to address the complex disease from various angles and patient segments.
The safety profile of the TECVAYLI-DARZALEX combination was reported as manageable and consistent with the known profiles of each drug individually. While rates of serious adverse events were high in both arms of the study, a common occurrence in advanced cancer trials, there were no new safety signals that would likely derail its path to approval.
For investors, the positive MajesTEC-3 results provide another pillar of growth for J&J’s massive pharmaceutical division, which continues to be the primary driver of the company's revenue. With an analyst consensus target price of around $203 and a dividend yield of approximately 2.5%, Johnson & Johnson remains a staple for investors seeking stability and long-term growth in the healthcare sector. These latest clinical results offer a clear catalyst that could drive analyst ratings and price targets higher in the coming months as the combination moves closer to full regulatory approval for earlier-line treatment.