ASH 2025 | A dual-targeting BCMA and CD19 FasTCAR-T (GC012F/AZD0120) as 1L therapy for newly diagnosed myeloma

I’m so glad to share our study, the GC-012F, a dual-targeting CAR-T, first CAR-T, now renamed AZD012F, as a first-line therapy in newly diagnosed multiple myeloma. Here we know CAR-T has demonstrated a substantial efficacy in relapsed and refractory multiple myeloma patients. However, the role of the CAR-T in newly diagnosed, particularly those with high risk and advanced age, remains to be defined. Early CAR-T therapy may enable early truncation of tumor heterogeneity, denying the emergence of drug resistance. So our previous study has demonstrated GC012F targeting two targets, BCMA and GPRC5D. It’s already shown a very deep and rapid, durable response with a manageable safety profile.
So we conducted two studies together based on this fast-track platform to perform the newly diagnosed study to observe the safety and efficacy. At ASH, we updated the combination data of these two studies to provide the long-term follow-up, more than three years’ follow-up results. And from our results of these two studies, including the transplant-eligible newly diagnosed patients and the transplant-ineligible newly diagnosed patients. Especially for the transplant-ineligible newly diagnosed patients, we focus on the elderly patients, all the patients aged over 70 years. A total of 30 patients enrolled in both two studies. We observed a very good tolerance and low-grade CRS. 30% of patients occurred in grade 1 CRS, and 3% occurred in grade 2. No grade 3 CRS were observed. No ICANS or IECHS/IECESS were observed. No any delayed toxicity and other side effects were observed.
Especially we observed a very high response rate. 100% achieved MRD negativity and sCR rate occurred 97%. The median time to first relapse at 28 days. The median time to best response at 68 days. The median time follow-up 36.5 months, that means three years. All the patients have very good survival. We haven’t observed the median PFS and the OS rates. After three years, the PFS was 98%. The three years, OS was 98%.
In the protocol, we just designed the lenalidomide maintenance therapy, but only 27 patients received lenalidomide maintenance therapy because others can’t tolerate the side effect. But from the 27 patients received lenalidomide maintenance therapy, only two patients relapsed progression and died. But for seven patients who did not receive lenalidomide maintenance therapy, five of them still disease-free survival. So from this study, we really observed a very good response and demonstrated the safety profile, which is a very high response rate and the long-term overall survival. So I think this is quite a large study so far. Focusing on the newly diagnosed, it might be provided the new treatment option for the NDMM patients.

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