Janssen's BCMA/CD3 Bispecific Antibody Tecvayli Approved in China for Relapsed or Refractory Multiple Myeloma

China Finance Network June 25th: Johnson & Johnson announced today that its innovative therapeutic drug Talique (Telituximab Injection) has been officially approved by the National Medical Products Administration (NMPA). It is indicated as a single agent for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Talikeo is the first bispecific antibody approved for the treatment of RRMM, targeting B-cell maturation antigen (BCMA) and CD3. It has previously been approved for marketing in countries or regions such as the United States and the European Union. This is the fourth product approved in China by Johnson & Johnson for the treatment of multiple myeloma, further enriching its leading portfolio in the fields of multiple myeloma and hematological oncology treatment, allowing more patients to have the opportunity to achieve functional cure.

Cherry Huang, President of Johnson & Johnson Innovative Medicine China, stated that as the world's first bispecific antibody approved for the treatment of multiple myeloma, Talquetamab once again demonstrates Johnson & Johnson's continuous efforts in innovating multiple myeloma diagnosis and treatment and improving patient outcomes. "In the future, we will continue to focus on areas with significant unmet medical needs, lead the future of medicine with science, fully promote the whole lifecycle management of cancer, and ensure our breakthrough achievements can help more patients prolong life and improve quality of life."

Data show that multiple myeloma is the second most common malignant tumor in the field of hematological tumors in China. As a highly heterogeneous blood cancer, almost all patients will face relapse or drug resistance during the treatment process. As the disease progresses, the more times a patient relapses, the higher the difficulty of subsequent treatment becomes, and the depth of remission after relapse also decreases, with the duration of sustained remission continuously shortening. Therefore, patients with relapsed or refractory multiple myeloma who have previously received at least three lines of therapy are in urgent need of more effective treatment options.

It is reported that Talike is a globally pioneering, ready-to-use, weight-based subcutaneous injection bispecific antibody that redirects CD3+ T cells to BCMA-expressing myeloma cells to induce tumor cell killing. Clinical trials have validated that Talike demonstrates a high response rate in patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy. Chinese patients benefit more significantly, with an overall response rate (ORR) reaching 76.9%.

The approval of Talquetamab was based on the results of a single-arm, open-label, multicenter study (MajesTEC-1), which evaluated the safety and efficacy of talquetamab in patients with relapsed or refractory multiple myeloma (n=165). The study included patients who had previously received at least three lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

The study results showed that the overall response rate (ORR) of telituximab reached 63% (95% CI: 55.2%, 70.4%), with 46.1% of patients achieving complete response (CR) or better (CR or stringent complete response [sCR]). The median time to first response was 1.2 months (range: 0.1-5.5 months).

Notably, according to the latest results published by EHA with a median follow-up of 30.4 months, the median duration of response was 24.0 (17.0-NE) months. In patients achieving ≥CR or better responses, the median duration of response has not yet been reached (26.7-NE). Meanwhile, Talquetamab significantly alleviates pain symptoms in patients, bringing sustained and clinically meaningful improvements to those with relapsed/refractory multiple myeloma.