Editor's Note: The 66th Annual Meeting of the American Society of Hematology (ASH) took place in San Diego from December 7 to 10, 2024. This prestigious event brought together global experts and scholars to discuss and exchange insights on the latest advancements in hematology. At this year’s meeting, Dr. Wenming Chen from Beijing Chaoyang Hospital presented findings from two significant studies featured in the poster sessions. These studies introduced promising therapeutic options for relapsed/refractory multiple myeloma (R/R MM), including the fully human BCMA CAR-T therapy, Zevorcabtagene Autoleucel (abstract #4762), and the novel anti-CD38 monoclonal antibody SG301 (abstract #4746). Hematology Frontier had the privilege of inviting Professor Chen to provide an in-depth interpretation of these groundbreaking studies, their clinical significance, and their potential to guide future treatment strategies in multiple myeloma.Abstract #4762
Subgroup Analyses of Phase 2 Study: Evaluating Fully Human BCMA CAR-T Therapy (Zevorcabtagene Autoleucel) for R/R MM
Dr. Wenming Chen:At the 2021 ASH meeting, the Phase 1 results of the LUMMICAR-1 study, with a one-year follow-up, showed an impressive overall response rate (ORR) of 100%, and a stringent complete response/complete response (sCR/CR) rate of 78.6%. Updated three-year data presented at the 2023 ASH meeting revealed that 92.9% of patients achieved very good partial response (VGPR) or better, with all sCR/CR patients reaching MRD negativity at a sensitivity of 10⁻⁵. The median progression-free survival (PFS) was 25 months, and the three-year overall survival (OS) rate was 92.9%.
At this year’s ASH meeting, we reported subgroup analyses from the Phase 1 study, which focused on how baseline characteristics influenced clinical outcomes of Zevorcabtagene Autoleucel in R/R MM patients. This included dose-escalation and dose-expansion cohorts.
Key findings demonstrated that efficacy was consistent across subgroups, regardless of age, disease stage, or cytogenetic abnormalities. Although the follow-up period for this subgroup analysis was only 18 months, the results are promising. Long-term follow-up will be essential to determine whether sustained remissions can be achieved, which would be highly beneficial for patients.
In China, two BCMA CAR-T therapies—Zevorcabtagene Autoleucel and Idecabtagene Autoleucel—are already approved. As we await further PFS data, these therapies are anticipated to play a vital role in advancing treatment outcomes for R/R MM patients.
Abstract #4746
First-in-Human, Multicenter Phase 1 Trial of SG301, a Novel Anti-CD38 Monoclonal Antibody, for R/R MM Patients
Dr. Wenming Chen:At this year’s ASH meeting, we also presented the Phase 1 clinical trial results for SG301, a novel humanized anti-CD38 monoclonal antibody. This study focused on the safety and efficacy of SG301 during dose-escalation phases.
Unlike existing anti-CD38 antibodies, SG301 targets a unique epitope, offering distinct advantages. Among 61 R/R MM patients treated with SG301, infusion-related adverse events were rare and predominantly mild (Grade 1–2), with very few severe (Grade 3–4) adverse events. This highlights SG301’s superior safety profile compared to other similar therapies.
In terms of efficacy, SG301 monotherapy achieved an ORR of 30.8%, with a VGPR rate of 23.1%. These outcomes surpass those observed in comparable trials, where response rates are typically around 20%.
These results underscore the remarkable capabilities of Chinese researchers in advancing myeloma therapies. SG301’s favorable safety and efficacy profiles make it a promising candidate for further trials. We look forward to the results from ongoing Phase 2 and Phase 3 trials, which we hope will replicate these encouraging findings and offer improved treatment options for R/R MM patients.
Expert Profile
Chief Physician and Professor, Department of Hematology, Beijing Chaoyang Hospital
- Leader of the Beijing Medical Administration Bureau’s Talent Team and Key Specialty in Multiple Myeloma
- Member, International Myeloma Working Group (IMWG)
- Standing Committee Member, Asian Myeloma Network (AMN), recipient of the AMN Outstanding Service Award from the International Myeloma Foundation (IMF)
- Executive Director, Chinese Medical Education Association; Chair of the Hematology Professional Committee
- Vice President, Beijing Popular Health Science Promotion Association
- Member, Hematology Physician Branch, Chinese Medical Doctor Association; Deputy Chair, Myeloma Expert Committee
- Deputy Head, Chinese Autologous Stem Cell Transplantation Working Group
- Standing Committee Member, Hematology Immunology Branch, Chinese Society of Immunology; Hematology Branch, Chinese Society of Geriatrics
- Standing Member, Anti-Leukemia Alliance of the Chinese Society of Clinical Oncology
- Standing Member, Hematologic Oncology Division of the Chinese Anti-Cancer Association
- Standing Member, Hematology Institutions Division, Chinese Hospital Association
- Member, Integrated Hematologic Diseases Committee, Integrated Medicine Branch, Chinese Medical Doctor Association
- Member, Hematopoietic Stem Cell Transplantation Group, Hematology Division, Chinese Medical Association
- Member, Hematology Committee, Cross-Straits Medical Association
