Innovative Dual Antibody Therapy for Difficult-to-Treat Multiple Myeloma Patients

In a significant advance for oncology, Johnson & Johnson (known in Japan as Janssen Pharmaceutical Company) has applied for a change in manufacturing and sales approval, aiming to introduce a novel treatment approach combining two dual-target specific antibodies: Tarvey® (generic name: torquetamab) and Tecvayli® (generic name: teclistamab). This combination is targeted at patients suffering from extramedullary disease associated with relapsed or refractory multiple myeloma—a challenging cancer that has historically lacked sufficient treatment options.

Significance of the Submission

The efficacy of the dual therapy was highlighted in the Phase II RedirecTT-1 study, where it achieved a remarkable overall response rate (ORR) of 78.9%, alongside a progression-free survival (PFS) rate of 61% at one year. This performance underscores the potential of the Tarvey® and Tecvayli® combination to fulfill an unmet medical need in a patient population where prognosis is typically poor.

Extramedullary disease (EMD) in multiple myeloma represents a more aggressive variant of the disease; myeloma cells proliferate outside the bone marrow, leading to tumor formations in soft tissues or organs. The limited treatment choices available to these patients are a pressing concern, as the existing therapeutic regimens often yield a low ORR. Current standard therapies demonstrate overall response rates of less than 40%, and median PFS is often below six months for triple-class exposed patients, indicating an urgent need for innovative therapeutic strategies.

The RedirecTT-1 Study

The RedirecTT-1 trial involved 90 patients over the age of 18 with extramedullary disease and a history of triple-class exposure to treatment (previously treated with immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies). Notably, 84.4% of participants had shown resistance to three classes of drugs, confirming the severity of their condition. The dual antibody therapy not only exhibited a high ORR but also noted that a majority of the responding patients achieved a complete response. This level of efficacy positions the Tarvey® and Tecvayli® combination as a promising option for this hard-to-treat patient demographic.

Future Implications

Yusri Elsayed, M.D., M.H.Sc., Ph.D., the head of the Oncology Therapeutic Area for Johnson & Johnson Innovative Medicine, expressed the company’s dedication to enhancing treatment options for patients battling extramedullary multiple myeloma, emphasizing that they have been contributing to the healthcare landscape in Japan for nearly two decades. He stated that the need for effective therapies remains high and that they aim to offer this new combination treatment to patients at the earliest opportunity.

Tarvey® and Tecvayli® work by redirecting T-cells to attack the malignant plasma cells associated with multiple myeloma. Tarvey® specifically targets G protein-coupled receptor 5D (GPRC5D), a novel target in multiple myeloma, whereas Tecvayli® targets B-cell maturation antigen (BCMA) and CD3, enhancing immune responses against cancer cells. Both agents have received regulatory approvals in various markets, including fast-track status in the US and conditional marketing authorization in the EU. Japan is poised to see their introduction in clinical settings as early as mid-2025, contingent upon regulatory approvals.

Conclusion

In summary, the prospective introduction of Tarvey® and Tecvayli® offers newfound hope for patients grappling with relapsed or refractory multiple myeloma featuring extramedullary disease. As Johnson & Johnson strives to advance cancer treatment, the focus remains on developing innovative solutions that cater to the pressing needs of patients facing substantial treatment barriers. The outcomes of the RedirecTT-1 study could potentially reshape therapeutic strategies and improve the longevity and quality of life for many patients.

For more information regarding Johnson & Johnson’s initiatives and innovative medicines, visit their official website.