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Estimated reading time: 4 minutesSince 2009, the first bispecific antibody Catumaxomab (Catumaxomab) After receiving EMA approval for marketing, the research and development enthusiasm for bispecific antibody drugs continues to rise.According to statistics, as of August 2023, a total of 12 bispecific antibody drugs have been approved for marketing worldwide (Catumaxomab was withdrawn from the market in 2017 due to commercial reasons.), 75% of which were concentrated in the period from 2022 to 2023.Thus, the harvest period for bispecific antibodies is still ongoing——Two BMCA×CD3 Bispecific Antibodies Report Positive Results in Two Days.On February 20, 2024, Johnson & Johnson announced that the FDA had approved the sBLA for Tecvayli (teclistamab) for patients with relapsed or refractory multiple myeloma (R/R MM) who have achieved and maintained complete response (CR) for at least six months.The dosing frequency was reduced to 1.5 mg/kg every two weeks (Q2W).Tecvayli as the world's first approved and marketedBCMA×CD3Bispecific antibody, also the first bispecific antibody in the MM field to be marketed, was initially approved in August 2022 (EMA) and subsequently received FDA approval for marketing in October of the same year. It is used to treat R/R MM patients who have previously undergone four or more lines of therapy.Initial Recommended Dose for PatientsStarting with incremental doses of 0.06 mg/kg and 0.3 mg/kg, followed by 1.5 mg/kg once weekly.Until disease progression or unacceptable toxicity occurs.This time, the approval of Tecvayli's biweekly dosing provides more options for eligible patients.In Johnson & Johnson's publicationOne day later (February 21), Regeneron announced that the FDA had agreed to prioritize the review of the BLA for linvoseltamab, intended for the treatment of R/R MM patients who have previously received at least three prior lines of therapy.The PDUFA date is August 22, 2024.Interestingly, linvoseltamab is also a BCMA×CD3 bispecific antibody, and currently, there are only two BCMA×CD3 bispecific antibodies on the global market: Johnson & Johnson's Tecvayli and Pfizer's Elrexfio.The BLA for linvoseltamab is based on data from a pivotal Phase I/II study (LINKER-MM1). According to the interim analysis results published in December 2023, with a median follow-up of 11 months, among 117 patients treated with linvoseltamab 200mg, the ORR assessed by IRC was 71%, and 46% of patients achieved CR or better efficacy.Optimization of existing products + upcoming approval of new products, boostingThe R&D Race Enthusiasm of BCMA×CD3 Bispecific Antibody Players.Products currently entering the clinical stage also include,BeiGene/Amgen's AMG-420, AbbVie/Amgen's TNB-383B,CM336 from Connomab, EMB-06 from EpimAb Biotherapeutics, etc.In Johnson & Johnson 2023In the financial report, Darzalex (Anti-CD38 IgG1 Monoclonal Antibody), Carvykti (the CAR-T developed in collaboration with Legend Biotech) — two standout drugs for MM treatment, with sales reaching $9.744 billion and $500 million, respectively. Adding to this,Tecvayli（BCMA×CD3Bispecific antibody), Talvey (CD3) launched in August 2023×GPRC5D Bispecific Antibody), which shows that Johnson & Johnson is continuously strengthening its MM stronghold.At the same time, Regeneron's close follow-up has become a microcosm of the development of MM treatment drugs. Currently,WithThe application of novel drugs such as proteasome inhibitors (e.g., bortezomib, carfilzomib), immunomodulatory agents (e.g., thalidomide, pomalidomide), and CD38 monoclonal antibodies (e.g., Darzalex, isatuximab) has significantly improved survival outcomes for patients with multiple myeloma (MM).As for the inevitable drug resistance and recurrence, withCAR-T therapies (such as Abecma, Carvykti, and Idecabtagene Vicleucel Injection), the addition of bispecific antibodies and even ADCs,Patients with R/R MM will also have more and better options.RootAccording to the 2023 version of the NCCN guidelines, this update recommends CAR-T therapy for the first time as a treatment option for refractory and relapsed patients. This marks a new era in the first-line treatment of MM, transitioning from traditional chemotherapy to immunotherapy, and we believe that one day the complete cure of MM will no longer be just a dream.References:
1. Johnson & Johnson Official Website
2.Regeneron Official Website
3. The first BCMA/CD3 bispecific antibody officially approved by the FDA, Johnson & Johnson launches new drug TECVAYLI (BioMedAdv)
4. Review: Mechanisms, Efficacy, Toxicity, and Optimal Sequencing of CAR-T and Bispecific Antibody Therapies for MM (Cell Gene Research Circle)
5. Other Public Information
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