The application was submitted based on the positive results of the pivotal Phase 1/2 clinical trial, LINKER-MM1. According to data released in December last year, when the median follow-up time was 11 months, patients who received the 200 mg dose of linvoseltamab in the Phase 1/2 clinical trial (involving 117 patients) demonstratedAn objective response rate of 71%,Among them, 46% of patients achieved complete remission or better outcomes.

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As of the latest data cutoff date, all patients receiving the 200 mg dose treatment experienced adverse events (AEs). Among them, 85% of patients had ≥ Grade 3 adverse events (AEs). The most common adverse event was cytokine release syndrome (CRS), which affected 46% of patients. Of these CRS cases, the majority (35%) were Grade 1, 10% were Grade 2, and only one case (1%) was Grade 3 CRS.

In addition,FDA has recently approved Johnson & Johnson's supplemental Biologics License Application for the BCMA\CD3-targeted bispecific antibody Tecvayli.Newly approved for use once every two weeks, specifically for the treatment of patients with relapsed or refractory multiple myeloma. This adjustment is based on the results of a phase I/II study, which initially recommended that patients receive Tecvayli treatment once a week.Subsequently, the treatment frequency was changed to once every two weeks.Only those patients who achieve and maintain complete remission (CR) for at least six months are eligible for this reduced dosing regimen.

In June 2023, Johnson & Johnson announced the long-term data of MajesTEC-1, showing that Tecvayli could still maintain a deep response in patients achieving complete remission even after reducing the dosing frequency.Among 165 RRMM patients who received weekly subcutaneous injections of teclistamab,The overall response rate reached 63%. Notably, 58.8% of patients achieved a very good partial response (VGPR) or better, and 39.4% of patients achieved a complete response (CR) or better.

▲Teclistamab Response Rate Data in the MajesTEC-1 Trial

After a median follow-up of approximately 12 months following the switch to a once-every-two-weeks regimen, the majority of patients continued to respond to Tecvayli, and a reduction in the incidence of grade 3 or higher infections was observed post-switch.

The biweekly dosing regimen was considered safe, with no new concerning side effect signals emerging. Tecvayli, as a bispecific antibody, can simultaneously target the BCMA protein and CD3 receptor, both of which are hallmark features of T-cell malignancies. The therapy received market approval through the FDA's accelerated approval pathway in October 2022.

As Two Bispecific Antibodies Gradually Enter Commercialization, the Field of Multiple Myeloma is Also Set to Witness a New Transformation. With the rapid development of biopharmaceuticals today, treatment options for multiple myeloma are becoming increasingly diverse, among which CAR-T and bispecific antibody therapies have gained particular attention.

CAR-T Therapy Demonstrates Extremely High Efficacy with an Objective Response Rate Close to 100%, Thanks to Its High Target Specificity and Personalized Customization. Additionally, the Persistence of CAR-T Cells in the Body Makes Them a Strong Candidate for Long-Term Treatment. However, High Costs and Potential Immune-Related Risks Remain Challenges.

Bispecific antibody therapy has garnered attention due to its dual mechanism of action, simple administration process, and relatively high safety. By simultaneously targeting two antigens, bispecific antibody therapy can effectively inhibit tumor growth, and its relatively straightforward treatment process reduces the risk of adverse reactions. However, compared to cell therapy, this therapy is less effective and requires long-term administration. Therefore, in the field of multiple myeloma, these two innovative therapies each have their own advantages.

Looking ahead, the competitive landscape of the multiple myeloma market will be doubly influenced by technological innovation and integrated treatment strategies. As new drugs and technologies continue to emerge, market competition will become increasingly intense. Meanwhile, patients will place greater emphasis on treatment efficacy and personalization, opting for the most suitable treatment plans for themselves.

Overall, CAR-T and bispecific antibody therapies each have their own advantages in the treatment of multiple myeloma. The future market competition landscape will continue to evolve with technological advancements and changes in patient needs. Complementary use of these therapies may become the main trend. Personalized treatment and comprehensive treatment will take the lead, while cooperation and competition will jointly drive the continuous prosperity of the market.

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