Myeloma

On March 2-3, 2024, the 7th Beijing Thrombosis and Hemostasis Conference and the 5th Beijing Hematologic Malignancies and Immunology Summit, hosted by the National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, was successfully held in Beijing.

In the not-too-distant future, CAR-T cell therapy products for multiple myeloma will gradually be launched and quickly enter the clinic, which is good news.

Carvykti Indication for Relapsed or Refractory Multiple Myeloma in Adult Patients.

On February 28, 2022, the U.S. FDA approved Ciltacabtagene Autoleucel (cilta-cel), a CAR-T cell therapy targeting B-cell maturation antigen (BCMA), for the treatment of patients with relapsed/refractory multiple myeloma (r/r MM).

Carvykti adopts a second-generation CAR-T structure with a murine-derived scFv and incorporates the 4-1BB co-stimulatory domain. It uses a lentiviral vector and is designed with two single-domain antibodies targeting BCMA extracellularly, resulting in stronger affinity.

CAR-T cell therapy is a form of cellular immunotherapy that involves genetically modifying T cells to express chimeric antigen receptors (CARs) that can directly recognize and bind to specific antigens on the surface of tumor cells, leading to T cell activation, proliferation, and targeted killing of tumor cells.

On February 28, 2022 (Horsham, Pennsylvania), Carvykti (cilta-cel) or Ciltacabtagene Autoleucel, a BCMA CAR-T product developed by Janssen, a subsidiary of Johnson & Johnson, and Legend Biotech, received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (MM).

On February 28, 2022, the FDA officially approved Ciltacabtagene autoleucel, a BCMA CAR-T therapy developed by Legend Biotech/Janssen, for the treatment of relapsed or refractory multiple myeloma.

Cilta-cel is a chimeric antigen receptor T-cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA), in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) to recognize and eliminate BCMA-expressing cells.

Based on the results of the Phase 3 CARTITUDE-4 study, the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11-0 in favor of a positive risk-benefit assessment for Carvykti®.

At 8:30 pm Beijing time on March 15, 2024, the FDA’s Oncologic Drugs Advisory Committee (ODAC) officially convened, with the meeting lasting over 9 hours.

Last week, the FDA released briefing documents from the Oncologic Drugs Advisory Committee (ODAC) meeting regarding Johnson & Johnson’s Carvykti (Ciltacabtagene autoleucel) and Bristol-Myers Squibb’s Abecma (Idecabtagene vicleucel), two CAR-T therapies. The documents highlighted the FDA’s concern over the higher early mortality rates observed in the treatment arms compared to the control arms in the clinical trials for these two CAR-T therapies.