Iaso Bio's CAR-T Therapy Equecabtagene Autoleucel Granted IND Approval in China for Earlier-Line Treatment of Relapsed/Refractory Multiple Myeloma

On March 28, IASO Bio announced the company's self-developed fully human BCMA-targeted CAR-T product.Idecabtagene Vicleucel Injection(Research code CT103A) has received approval from the China National Medical Products Administration (NMPA) for a new indication clinical trial application, intending to expand its indications for use.Treatment of relapsed/refractory multiple myeloma patients who have previously undergone 1-2 lines of therapy and are lenalidomide-resistant。

Source of Screenshot:CDE Official Website

Multiple Myeloma (MM) is one of the most common hematologic tumors, a malignant disease characterized by the clonal proliferation of abnormal plasma cells. For newly diagnosed multiple myeloma patients, first-line treatments often include induction therapy, consolidation therapy, and maintenance therapy with various drug combinations, as well as autologous hematopoietic stem cell transplantation (ASCT), among others. For the majority of patients, even after achieving disease remission, they will inevitably face the challenge of relapse and refractory treatment.

Idecabtagene Vicleucel Injection is a BCMA-targeted CAR-T product, which was previously approved for marketing in China in June 2023.For the treatment of adult patients with relapsed or refractory multiple myeloma who have progressed after at least three prior lines of therapy (including at least one proteasome inhibitor and one immunomodulatory agent).. The approval of this end-line treatment indication is based on the clinical research data from the China multi-center Phase 1/2 registrational clinical trial FUMANBA-1, which evaluated the efficacy of Icaritin injection in treating patients with relapsed/refractory multiple myeloma.

According to the latest long-term follow-up data of this study presented at the 2023 annual meeting of the International Myeloma Society (IMS):

• As of December 31, 2022, among the 103 evaluable subjects for efficacy,The overall response rate (ORR) was 96.1%.，The strict definition of complete response (sCR/CR) rate was 77.7%.；

• Among 91 subjects with no prior history of CAR-T treatment,ORR reached 98.9%, sCR/CR rate reached 82.4%, and the 12-month progression-free survival (PFS) rate was 85.5%.；

• 94.2% (97/103) of subjects achieved MRD negativityAll CR/sCR subjects achieved MRD negativity;

• Among the 105 subjects receiving treatment, only one subject experienced ≥Grade 3 CRS, and no ≥Grade 3 ICANS occurred.

• Pharmacokinetic data show that Icarus injection can persist in the body for a long time after infusion, and at 24 months, gene copy numbers can still be detected in 40% of subjects.

Ms. Zhang Jinhua, Founder, Chairperson and Chief Executive Officer of IASO Bio, stated: "The IND approval for the 2-3 line indication in relapsed/refractory multiple myeloma marks another significant milestone in the clinical development process of the Equecabtagene Autoleucel Injection.As can be seen from relevant studies,RRMM Patients Benefit More from Earlier Use of CAR-T TherapyBased on the excellent efficacy and safety demonstrated in previous clinical studies, IASO Bio's injectable product, Equecabtagene Autoleucel, is expected to fill a significant unmet clinical need in the early treatment stage of multiple myeloma. We will initiate the clinical enrollment process as soon as possible, allowing more patients with early relapse to benefit from this therapy."

References:

[1] IASO Bio's Idecabtagene Vicleucel Injection for the Treatment of 2-3 Line Multiple Myeloma Approved for Clinical Trials. Retrieved Mar 28, 2024, from https://mp.weixin.qq.com/s/spBgTUMuda_hY06LO6IvWg