Turby® and its Impact on Multiple Myeloma Treatment
Turby®, a bispecific antibody targeting GPRC5D and CD3, has recently shown profound and durable efficacy in Japanese patients with recurrent or refractory multiple myeloma. Following the release of results from the sub-group analysis of the phase I/II MonumenTAL-1 trial, the treatment demonstrated a significant overall response rate (ORR) of 77.8% after a median follow-up of 13.4 months. This promising outcome has been consistent even among clinically significant patient populations.
The analysis specifically focused on patients who had experienced at least three lines of standard therapy, which usually include immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies. These results underline the potential of Turby® as a vital treatment option in managing this challenging blood cancer, which remains difficult to cure despite advancements in therapy.
In efforts to assess the efficacy and safety, the MonumenTAL-1 trial included a total of 300 subjects, with a specific analysis involving a cohort of 36 Japanese patients. The study confirmed Turby®'s effectiveness at the recommended phase II dosing schedule, suggesting it to be a robust alternative for those who have limited treatment options.
According to Johnson & Johnson (J&J), the company behind Turby®, this bispecific antibody binds to T-cell surface CD3 receptors as well as GPRC5D, which is frequently overexpressed on multiple myeloma cells. This dual-target capability allows for a unique therapeutic approach, making it stand out as the first approved bispecific antibody in its category globally.
The release of these findings at the 2025 87th Annual Meeting of the Japanese Society of Hematology has generated excitement within the medical community. J&J's ongoing commitment to provide effective treatment alternatives for difficult cases of multiple myeloma is clear, as they anticipate that Turby® will play a key role in the advancement of myeloma therapies in Japan.
The significance of Turby® cannot be overstated. Patients dealing with recurrent or refractory multiple myeloma often experience a cycle of relapse and the need for alternative therapies, which can lead to worse patient outcomes over time. In Japan, the increase in the incidence of multiple myeloma, with about 7,800 diagnosed in 2021 and an estimated 4,300 deaths due to the disease in 2023, underscores the urgent need for improved treatment options.
Additionally, in the MonumenTAL-1 Japanese cohort, response metrics included 72.2% achieving Very Good Partial Response (VGPR) or higher, and 55.6% achieving Complete Response (CR). Notably, in sub-group analyses of high-risk cytogenetic alterations, a DOR (Duration of Response) rate of 58.4% was recorded, corroborating Turby®’s efficacy even in challenging patient populations.
In terms of safety, findings were consistent with those recorded in international studies, and no new safety signals were identified. The most common Grade 3/4 adverse events included hematological toxicities, notably lymphopenia and anemia, highlighting the need for careful monitoring during treatment. Immunotherapy-related side effects, although present, largely remained manageable with reported cases of Cytokine Release Syndrome (CRS) treated without stopping therapy.
Dr. Yusri Elsayed, head of Oncology at J&J Innovative Medicine Global Therapeutic Area, emphasized the significance of Turby® as a crucial treatment option for patients with a history of therapy, particularly for those with challenging cytogenetic profiles. By offering a deep and sustained response, Turby® represents hope for better outcomes in a subgroup that has limited access to effective treatments.
As this groundbreaking treatment is set to launch in Japan by June 2025 following its manufacturing approval, Turby® stands to increasingly enhance how medical professionals tackle multiple myeloma, further shaping the future landscape of cancer therapy. The potential of this BISpecific antibody could indeed pave the way for innovative treatments tailored to individual patient needs.
In conclusion, the insight gained from the MonumenTAL-1 trial shines light on a new era in myeloma treatment. With data supporting Turby®'s capability to address unmet medical needs, its impact on patient management and therapies will likely serve as a model for future advancements in oncology.