Dr Usmani Highlights Teclistamab Efficacy, Tolerability in Patients With R/R MM

In an interview with Oncology Learning Network, Saad Z. Usmani, MD, MBA, FACP, Chief of Myeloma Service at Memorial Sloan Kettering Cancer Center (MSK), New York, NY, spoke on the findings and clinical significance of a multicenter, open-label, single-arm, phase 1 study on teclistamab, a B-cell maturation antigen (BCMA) and CD3 bispecific antibody, in patients with relapsed or refractory (R/R) multiple myeloma (MM).

What existing data led you and your co-investigators to conduct this research?

BCMA is highly expressed on myeloma cells, preclinical and clinical studies had shown CAR T-cells targeting BCMA to be efficacious.

It was rationalized that T-cell redirection using bispecific antibodies would be a promising strategy in MM.

Please briefly describe your study and its findings. 

Teclistamab is a BCMA directed bispecific antibody, evaluated in this first-in-human/phase 1 trial initially using intravenous (IV) route of administration for early dose escalation, but later followed by subcutaneous formulation for easier and more convenient administration for the patients.

The patient population included 157 R/R MM patients who had prior PI, IMiD and anti-CD38 antibodies, with 6 median prior lines of therapies.

There were no dose limiting toxicities (DLTs) observed, and the recommended phase 2 dose (RP2D) picked for phase 2 was 1500 ug/kg after 2 step-up doses.

Cytokine release syndrome (CRS) was seen in 70% of the patients at the RP2D and all were grade 1 or 2. The ORR was 65%, with 58% of patients getting to very good partial response (VGPR) or better.

Were any of the outcomes particularly surprising?

The results have been very impressive for this patient population, and similar to idecabtagene vicleucel (ide-cel) CAR-T that is currently FDA approved. The safety profile for CRS and neurotoxicity appears to be good.

What are the possible real-world applications of these findings in clinical practice?

Teclistamab is undergoing FDA review for potential approval for R/R MM later this year.

Do you and your co-investigators intend to expand upon this research? If so, what are/will be your next steps?

Teclistamab is now being studied in combination with other therapies in MM, and more data will be forth coming in future meetings.