▎WuXi AppTec Content Team Report

Public information shows that Telitumab is aReady-to-use, subcutaneous injectable bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3 receptor on T lymphocytesIt can recruit CD3-positive T cells to the vicinity of myeloma cells expressing BCMA, and activate T cells to attack tumor cells. Previously, this product has been granted Breakthrough Therapy Designation by the U.S. FDA for the treatment of multiple myeloma, and awarded the Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).

Previously, Talimogene laherparepvec treatmentRRMMThe safety and efficacy in adult patients have been validated in a clinical trial named MajesTEC-1. Based on the positive results of this clinical trial, Teclistamab was successively approved for marketing by the EU and FDA in 2022, for the treatment ofRRMMAdult patients. According to an earlier press release from Johnson & Johnson, it is the first bispecific therapy approved for the treatment of multiple myeloma and also the first bispecific antibody targeting BCMA to gain approval.Provides a "ready-to-use" treatment option for refractory patients。

February 2024,Talimogene LaherparepvecThe supplemental Biologics License Application (sBLA) has once again received FDA approval.Approval，For reducing the dosing frequency to once every two weeks (1.5mg/kg) in RRMM patients who have achieved and maintained complete response (CR) for at least six months.

MajesTEC-1 is a Phase 1/2 single-arm, open-label, multi-cohort, multi-center dose escalation study designed to evaluateTrelustatMonoclonal AntibodyIn patients who have previously received three or more treatmentsRRMMSafety and effectiveness in adult patients.InIn the pivotal Phase 2 clinical trial,Patients participating in the trial (N=110) had a median number of 5 prior treatments.。The test results showed that this patient populationThe overall response rate reached 61.8%.。Notably, 28.2% of patients achieved a complete response or better.At a median follow-up time of 7.4 months,The estimated 6-month remission persistence rate is 90.6%, and the 9-month remission persistence rate is 66.5%.。

August 2023,TrelustThe marketing application of the monoclonal antibody has been granted priority review by the CDE for the indication of monotherapy in adult patients with relapsed or refractory multiple myeloma who have previously received at least three types of treatment (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody). This is precisely the indication that has been recently approved.The approval of Telituximab in China will bring a new treatment option to more Chinese patients with multiple myeloma.

[2] Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Retrieved August 24, 2022, from https://www.businesswire.com/news/home/20220822005274/en

[3] U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. Retrieved October 25, 2022, from https://www.prnewswire.com/news-releases/us-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-301659083.html

[4] Moreau et al., (2022). Teclistamab in Relapsed or Refractory Multiple Myeloma. NEJM, DOI: 10.1056/NEJMoa2203478