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Janssen BCMA double antibody + CAR-T cell have made progress!
Janssen BCMA double antibody + CAR-T cell have made progress! Janssen BCMA double antibody + CAR-T cell, two major therapies have made progress!
01. Identification of CD3/BCMA dual-antibody breakthrough therapy
On June 1, Johnson & Johnson’s Janssen Pharmaceuticals announced that the FDA granted its CD3/BCMA dual antibody therapy teclistamab a breakthrough therapy designation (BTD) for the treatment of relapsed or refractory multiple myeloma.
teclistamab is a ready-made T cell redirection bispecific antibody against B cell maturation antigen (BCMA) and CD3 receptor. It can redirect CD3-positive T cells to BCMA-expressing myeloma cells to induce tumor cell killing. Preclinical research results show that teclistamab can kill myeloma cell lines and bone marrow-derived myeloma cells from a large number of pretreated patients.
Currently, Teclistamab is evaluating a phase II clinical study (NCT04557098) for the treatment of relapsed or refractory multiple myeloma, and is being explored in a joint study (NCT04586426, NCT04108195, NCT04722146). In 2020, the European Commission and the US Food and Drug Administration respectively granted teclistamab orphan drug designation for the treatment of multiple myeloma. In January 2021, teclistamab was granted PRIME (Priority Medicine) designation by the European Medicines Agency (EMA).
02. Clinical progress of BCMA CAR-T cell therapy
On the same day, Janssen announced that its BCMA CAR-T cell therapy ciltacabtageneautoleucel (cilta-cel), jointly developed with Legend Bio, for the treatment of patients with multiple myeloma, has obtained the latest clinical trial results. The relevant data will be presented at the 2021 ASCO annual meeting (Abstract number: # 8005) and announced at the EHA conference in 2021.
The data comes from the 18-month follow-up record of the key CARTITUDE-1 study of phase 1b/2. Among 97 patients with pre-treated multiple myeloma, the long-term follow-up showed an overall response rate (ORR) of 98%, of which 80% Of patients achieved a strict complete response (sCR), a progression-free survival (PFS) rate of 66%, and an overall survival rate (OS) rate of 81%.
Cilta-cel is composed of a structurally differentiated CAR-T and two single domain antibodies targeting BCMA. It is used for the treatment of patients with relapsed or refractory multiple myeloma and early treatment. In December 2017, Janssen signed an exclusive global license and cooperation agreement with Legend Bio to develop and commercialize cilta-cel. In April 2019, cilta-cel received the Priority Drug (PRiME) designation granted by the European Commission; in December 2019, the FDA granted it Breakthrough Therapy Designation (BTD); and in August 2020, it was granted BTD in China.
It is worth mentioning that on March 27, the world’s first BCMA CAR-T cell therapy was approved for marketing, which was jointly developed by Bristol-Myers Squibb (BMS) and bluebird bio, Inc.
(source:internet, reference only)