Key Takeaways
- CARVYKTI® significantly improves overall survival in multiple myeloma patients.
- The treatment shows a 45% reduction in the risk of death compared to standard therapies.
- High complete response rates and overall response rates were observed.
- Consistent safety profile with manageable adverse events.
In a groundbreaking development, Johnson & Johnson has released long-term results from the Phase 3 CARTITUDE-4 study, showcasing significant advancements in the treatment of relapsed or lenalidomide-refractory multiple myeloma. The findings were presented at the 2024 International Myeloma Society (IMS) Annual Meeting and represent a major milestone in the fight against multiple myeloma. These results highlight that a single infusion of CARVYKTI® can substantially prolong overall survival in patients with difficult-to-treat cases.
The CARTITUDE-4 study compared the efficacy of CARVYKTI® to standard therapies such as PVd (pomalidomide, bortezomib, and dexamethasone) and DPd (daratumumab, pomalidomide, and dexamethasone) in patients who had received at least one prior line of therapy. Results demonstrated that CARVYKTI® reduced the risk of death by 45% compared to these standard therapies, underscoring a significant improvement in both overall survival and quality of life for patients. At a median follow-up of nearly three years, the overall survival rate was 76% in the CARVYKTI® group, compared to 64% in the standard therapy group, further emphasizing its potential as a superior treatment option.
CARVYKTI® Demonstrates Superior Efficacy and Safety Profile in Achieving Long-Term Disease Control for Multiple Myeloma
CARVYKTI® also showed remarkable efficacy in achieving high response rates. The study reported a complete response or better rate of 77% and an overall response rate of 85%, both of which significantly outperformed standard therapies. Additionally, patients in the CARVYKTI® arm had a minimal residual disease (MRD) negativity rate of 62% at the 10^-5 threshold, compared to only 18.5% in the standard therapy arm. These results indicate that CARVYKTI® can provide deeper and more durable responses, which are critical for long-term disease control.
Moreover, the safety profile of CARVYKTI® remained consistent with previous findings, with cytopenia being the most common adverse event. Notably, the occurrence of treatment-emergent infections was lower in the CARVYKTI® group (64%) compared to the standard therapies (76%), indicating a relatively favorable safety profile. These findings reinforce the potential of CARVYKTI® as a viable and less risky option for patients who may already be immunocompromised due to prior treatments.
CARVYKTI® Gains FDA and European Approval, Offering New Hope for Lenalidomide-Refractory Multiple Myeloma Patients
CARVYKTI® has already received approvals from both the U.S. FDA and the European Commission for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. With more than 3,500 patients treated globally, this innovative therapy is making a profound impact in the oncology field and continues to gain momentum as a leading treatment option.
As the first and only cell therapy to demonstrate improved overall survival in lenalidomide-refractory multiple myeloma patients, CARVYKTI® offers new hope for those in need of effective treatment as early as the second line of therapy. This significant advancement underscores Johnson & Johnson’s ongoing commitment to developing cutting-edge treatments to address the unmet needs of healthcare providers and patients worldwide. The company intends to submit these compelling results to health authorities globally to expand the availability of CARVYKTI®, ensuring that more patients can benefit from this life-saving therapy.
Resource: Johnson & Johnson, September 27, 2024
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