Breakthrough Therapy for High-Risk Multiple Myeloma Shows Promising Results

Introduction to Eque-cel Therapy

IASO Bio, a leading biopharmaceutical company, has recently presented groundbreaking clinical data on their innovative CAR-T cell therapy, Eque-cel. This new treatment has been developed for patients newly diagnosed with high-risk multiple myeloma who are not eligible for stem cell transplants. The data was unveiled at the 2024 European Hematology Association (EHA) Annual Congress in Madrid, Spain.

Study Overview: FUMANBA-2

The FUMANBA-2 study is a phase I, single-arm, open-label, multicenter clinical trial. The primary focus of the study is to evaluate the efficacy, safety, and pharmacokinetics of Eque-cel in subjects with high-risk newly diagnosed multiple myeloma. The research is spearheaded by Professor Lijuan Chen and Professor Bing Chen, who are renowned experts in the field.

Induction Treatment Procedure

Patients participating in the study undergo four cycles of induction treatment before receiving Eque-cel infusion. Those identified as unsuitable for autologous stem cell transplant complete a peripheral blood mononuclear cell collection after the third cycle. Eque-cel is then administered at a dose of 1×106 CAR-T cells per kilogram of body weight.

Primary and Secondary Endpoints

The primary endpoints of the study include the proportion of subjects who achieve minimal residual disease (MRD) negativity and progression-free survival (PFS). Secondary endpoints encompass overall response rate (ORR), duration of response (DOR), safety profiles, and pharmacokinetic characteristics (PK/PD).

Promising Efficacy Results

The median follow-up duration for patients in this study was 7.46 months. The 12-month progression-free survival rate was observed at 84.4%. Impressively, all participants achieved MRD negativity, with over 71% maintaining this status for more than a year. Additionally, the overall response rate stood at 100%, with 93.8% of patients reaching stringent complete response.

Safety Profile

Post Eque-cel infusion, the majority of adverse effects reported were mild. The occurrence of grade 1-2 cytokine release syndrome (CRS) was 68.8%, and no severe (grade 3 or higher) CRS or neurotoxicities were recorded. The most common significant adverse effect was a reduction in blood cell counts, with a 25% incidence of serious infections.

Pharmacokinetics Insights

The peak CAR copy number in patients’ blood was observed within 10 days post-infusion. Moreover, the clearance of free B-cell maturation antigen (sBCMA) was achieved in 81.25% of patients within one month following the Eque-cel treatment.

Expert Opinions

Professor Lijuan Chen highlighted the exceptional efficacy and safety of Eque-cel, emphasizing its potential to improve outcomes for high-risk multiple myeloma patients ineligible for transplants. She pointed out that this is the first time CAR-T therapy is being tested as a first-line treatment in this patient group.

Additionally, Professor Bing Chen praised the therapy for showing superior results over standard first-line treatments. He noted that Eque-cel's use may lead to sustained remissions and an improved prognosis for these high-risk patients.

About IASO Bio

IASO Bio is dedicated to the discovery and development of novel cell therapies and antibody products for oncology and autoimmune diseases. Their portfolio includes over ten innovative products, with Eque-cel being a key highlight. The company aims to deliver transformative therapies that address unmet medical needs globally.

Future Prospects

As research continues, IASO Bio looks forward to expanding the use of Eque-cel and similar CAR-T therapies, potentially benefiting a larger population of patients suffering from high-risk multiple myeloma and other challenging conditions.