New Data on Daratumumab-Based Therapy for Untreated Multiple Myeloma in Japan

Groundbreaking Data on Daratumumab-Based Therapy for Multiple Myeloma in Japan

Overview

Recent clinical data from the CEPHEUS trial have shed light on the efficacy of a four-drug combination therapy involving Daratumumab, particularly for patients suffering from untreated multiple myeloma in Japan. The findings are particularly notable as they indicate a significant improvement in measurable residual disease (MRD) negativity rates, which are critical markers of treatment success. The study, presented by Johnson & Johnson's Janssen Pharmaceuticals, emphasizes that these advancements are consistent with results observed in broader international patient populations.

Details of the Study

The phase III CEPHEUS trial (NCT03652064) focused on patients who were either ineligible for or had deferred hematopoietic stem cell transplantation due to their newly diagnosed multiple myeloma. Within this cohort, the therapeutic regimen evaluated consisted of Daratumumab combined with Velcade (bortezomib), Revlimid (lenalidomide), and dexamethasone, referred to as DVRd therapy. Results from the trial's Japanese subgroup demonstrated profound and lasting responses, with an impressive 77.8% MRD negativity rate at a sensitivity threshold of 10-5. Moreover, the DVRd treatment group displayed a substantial 66% reduction in the risk of disease progression or death compared to the Velcade, Revlimid, and dexamethasone (VRd) combination group.

Statistical Outcomes

Over a median follow-up of 58.7 months, the DVRd therapy group achieved a MRD negativity rate of 60.9%, outperforming the VRd group at 39.4%. Similarly, patients who maintained MRD negativity for over 12 months were approximately twice as prevalent in the DVRd group (48.7% compared to 26.3% in the VRd group). This outcome reinforces the potential of DVRd therapy to offer deeper and sustained responses in patients without prior treatment. The progression-free survival (PFS) data further emphasizes the advantage of DVRd therapy, with a relative hazard ratio reduction of 43% compared to traditional VRd therapy.

Implications for Treatment

Yusri Elsayed, M.D., from Johnson & Johnson, pointed out that achieving deep and sustained responses in the initial treatment of multiple myeloma can significantly impact patient prognosis and overall survival. The DVRd therapy, by demonstrating consistent efficacy even within the Japanese patient demographic, highlights a significant step forward in offering targeted treatment options for those who cannot undergo transplant procedures. The trial results were recently discussed at the 87th Annual Meeting of the Japanese Society of Hematology, marking a pivotal moment in hematology research within Japan.

Safety Profile

The safety profile of the DVRd regimen showed consistency with established safety profiles for the individual components without the emergence of new safety signals. This suggests that DVRd therapy could present a favorable balance of risk versus benefit, making it a viable treatment option for Japanese patients with untreated multiple myeloma who are not transplant-eligible.

The Future of Multiple Myeloma Treatment in Japan

The CEPHEUS trial has opened new avenues in the treatment landscape for multiple myeloma, given that almost 395 patients were involved across 13 countries including Japan. This extensive data supports the ongoing evolution in how multiple myeloma is managed. The latest findings underline the impact of innovative therapies like DVRd in overcoming the challenges faced by patients, potentially leading to better health outcomes and an enhanced quality of life.

Furthermore, Daratumumab, marketed in Japan under the name Darakuro®, was approved for multiple myeloma treatment in March 2021 and is being integrated into multiple treatment regimens as of June 2025. This integration showcases the continuing evolution of therapeutic strategies available to clinicians and patients alike.

Conclusion

In summary, the promising results from the Japanese subgroup analysis of the CEPHEUS trial reinforce the potential of early and effective intervention strategies in managing untreated multiple myeloma. By integrating therapies like DVRd, healthcare professionals can make informed decisions that align with the needs of their patients, thereby promoting significantly better treatment paradigms and patient care standards.