Johnson & Johnson’s CARVYKTI® demonstrates significant overall survival improvement in multiple myeloma patients after one prior line of therapy in Phase 3 CARTITUDE-4 study.
Key points:
- CARVYKTI® is the first cell therapy to significantly improve overall survival versus standard of care in second-line multiple myeloma treatment.
- The study compared CARVYKTI® to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).
- Safety data were consistent with the approved label, supporting CARVYKTI®’s established safety profile.
Market estimate: The global multiple myeloma therapeutics market is expected to reach $31 billion by 2026, according to a report by Global Market Insights.
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Tuesday, Johnson & Johnson (NYSE: JNJ) announced positive results from its Phase 3 CARTITUDE-4 study. The study’s second interim analysis reveals that CARVYKTI® (ciltacabtagene autoleucel), a revolutionary CAR-T cell therapy, has achieved a statistically significant and clinically meaningful improvement in overall survival for patients with relapsed or lenalidomide-refractory multiple myeloma after just one prior line of therapy.
This breakthrough positions CARVYKTI® as the first cell therapy to demonstrate such a significant survival benefit in second-line treatment for multiple myeloma, a notoriously challenging blood cancer to treat. Dr. Jordan Schecter, Vice President and Disease Area Leader for Multiple Myeloma at Johnson & Johnson Innovative Medicine, emphasized the significance of these results: “CARVYKTI, a one-time infusion, is now the first cell therapy to significantly improve overall survival versus standard of care for patients with myeloma as early as second line.”
The CARTITUDE-4 study, which compared CARVYKTI® to standard therapies like pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd), has set a new benchmark in multiple myeloma treatment. This comparison against established therapies underscores the potential of CARVYKTI® to revolutionize the treatment landscape.
Importantly, the safety profile of CARVYKTI® in this study remained consistent with its approved label, providing reassurance to both healthcare providers and patients. This balance of efficacy and safety is crucial in the realm of cancer therapeutics, particularly for a treatment targeting earlier lines of therapy.
The implications of these results extend far beyond the clinical trial setting. Multiple myeloma, the third most common blood cancer worldwide, affects thousands of lives annually. In 2024 alone, it was estimated that over 35,000 people would be diagnosed with multiple myeloma in the U.S., with more than 12,000 expected to succumb to the disease. The five-year survival rate for multiple myeloma patients stands at 59.8%, highlighting the urgent need for more effective treatments.
The global multiple myeloma therapeutics market, valued at $19.5 billion in 2020, is projected to reach $31 billion by 2026. CARVYKTI®’s promising results position it to potentially capture a significant share of this growing market, offering hope to patients and potentially reshaping treatment paradigms.
CARVYKTI®’s journey to this point has been marked by rapid progress. It received U.S. Food and Drug Administration approval in February 2022 for later-line treatment and expanded its indication in April 2024 to include patients who have received at least one prior line of therapy. Similar approvals have been granted in Europe and Japan, reflecting the global recognition of CARVYKTI®’s potential.
