Presentation during EHA2022: All Oral presentations were presented between Friday, June 10 and Sunday, June 12 and is accessible for on-demand viewing from Monday, June 20 until Monday, August 15, 2022 on the Congress platform.
CT103A, a fully human BCMA-directed CAR-T therapy, showed excellent safety and promising efficacy in the ongoing phase 1/2 FUMANBA-1 study (ChiCTR1800018137, NCT05066646) in patients with relapsed/refractory multiple myeloma (Wang, ASH, 2021).
As of Jan 21, 2022, 79 patients received CT103A with the median follow-up of 9.6 months (range 1.2, 40.0). 28 (35.4%) patients had high-risk cytogenetic abnormality defined as del(17p), t(4;14), or t(14;16), and 11 (13.9%) had extramedullary plasmacytomas. Patients received a median of 5 (range 3, 23) prior lines of therapy. Notably, 13 (16.5%) had received prior non-human BCMA-targeted CAR-T cell therapy.
ORR was 94.9% (75/79), with 55 (69.6%) patients achieving CR/sCR, and 71 (89.9%) achieving ≥VGPR. Median TTR was 16 days (range 11, 123), and the median time to CR/sCR was 95 days (range 14, 557). For 13 patients who had prior CAR-T therapy, ORR was 98.5%, with 6 (46.2%) achieving CR/sCR. For 11 patients with extramedullary disease at baseline, ORR was 100%, with 9 (81.8%) achieving CR/sCR. All patients with CR/sCR were MRD-negative. The median duration of MRD negativity was not reached. The probability of MRD negativity at month 12 was 88.7% (95% CI 65.9%, 96.6%).
Updated data from the Phase 1/2 FUMANBA-1 study continue to show encouraging efficacy of CT103A with a favorable safety profile in relapsed/refractory multiple myeloma. CT103A led to a deepening and durable response with robust expansion and prolonged persistence. Patients with prior BCMA CAR-T therapy could still benefit from CT103A.