Biopharmaceutical company IASO Bio has announced that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application for Equecabtagene Autoleucel, a fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) autologous T-cell injection. This approval allows for an expanded indication in treating relapsed and/or refractory multiple myeloma (R/RMM) patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide.
The approval is based on data from the pivotal FUMANBA-1 study, which showed promising results. Among the 103 efficacy-evaluable patients, the overall response rate (ORR) was 96.1% and the stringent complete response/complete response (sCR/CR) rate was 77.7%. Additionally, in 91 participants without prior CAR-T therapy, the ORR was 98.9% and 82.4% of patients reached sCR/CR. The 12-month progression-free survival (PFS) rate was 85.5%. Furthermore, 94.2% of patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. Only one participant experienced ≥ Grade 3 cytokine release syndrome (CRS) and there were no cases of ≥ Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS).
Multiple myeloma is a prevalent hematological malignancy with no known cure. CAR-T therapy has shown significant promise in improving clinical response and prolonging progression-free survival in relapsed/refractory multiple myeloma patients who have received previous treatments.
The approval of Equecabtagene Autoleucel for second- and third-line treatment of R/RMM is seen as a pivotal advancement in its clinical journey. IASO Bio aims to extend the benefits of this innovative therapy to more patients experiencing early relapse.
Biopharmaceutical company IASO Bio operates in the biopharmaceutical industry, specifically focusing on developing innovative therapies for the treatment of various diseases.IASO Bio is dedicated to advancing healthcare by leveraging cutting-edge technologies and scientific breakthroughs.
The market for biopharmaceuticals continues to grow rapidly. According to a report by Grand View Research, Inc., the global biopharmaceutical market is expected to reach a value of $526.0 billion by 2025. This can be attributed to factors such as the increasing prevalence of chronic diseases, advancements in biotechnology, and the rising demand for personalized medicine.
Within the biopharmaceutical industry, CAR-T therapy has gained significant attention and is considered a game-changer in the treatment of certain cancers, including multiple myeloma. CAR-T therapy involves modifying a patient’s own immune cells to recognize and attack cancer cells. This personalized approach has shown promising results in clinical trials, with improved response rates and prolonged survival.
IASO Bio’s Equecabtagene Autoleucel, a fully-human anti-BCMA CAR-T cell therapy, has received approval from the China National Medical Products Administration for the treatment of relapsed and refractory multiple myeloma patients. This approval marks a significant milestone in the company’s journey and opens up new possibilities for patients who have not responded to previous therapies.
The pivotal FUMANBA-1 study demonstrated the efficacy of Equecabtagene Autoleucel, with an overall response rate of 96.1% and a stringent complete response/complete response rate of 77.7%. The study also showed a high rate of minimal residual disease negativity, indicating a deeper level of response. Furthermore, the therapy demonstrated a favorable safety profile, with minimal severe side effects.
Despite the remarkable progress in CAR-T therapy, there are still challenges and issues to address. One such challenge is the high cost of manufacturing CAR-T cells, which can limit access to this innovative treatment. Additionally, managing and mitigating potential side effects, such as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, requires careful monitoring and intervention.
IASO Bio remains committed to advancing the field of CAR-T therapy and aims to bring the benefits of Equecabtagene Autoleucel to a wider range of patients, particularly those who experience early relapse. By expanding indications and exploring combination therapies, the company seeks to improve outcomes for patients with relapsed and refractory multiple myeloma.
For more information about IASO Bio and its groundbreaking therapies, visit their website: IASO Bio.