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How to sequence BCMA-directed therapies in early relapsed/ refractory multiple myeloma
At the ESH 7th Translational Research Conference:
Multiple Myeloma
with Martin Kaiser, Mohamad Mohty, and Rakesh Popat
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Teclistamab is a T-cell directed bispecific antibody that binds to CD3 and B-cell maturation antigens on plasma cells. Results from the phase II part of the MajesTEC-1 trial (NCT04557098) resulted in the approval of teclistamab by the U.S. Food and Drug Administration (FDA) in October 2022 for the treatment of relapsed/refractory multiple myeloma. While results from the trial were positive, the stringent inclusionary criteria limited the representation of real-world patients, who commonly present organ dysfunction, significant comorbidities, and high-risk disease characteristics.
During the 65th American Society of Hematology Annual Meeting and Exposition, Dima presented results from a retrospective analysis to evaluate the real-world safety and efficacy of teclistamab, with a focus on patients who would have been ineligible for the MajesTEC-1 trial. We summarize the key findings below.
Check out our top abstracts presented at the 65th ASH Annual Meeting and Exposition here. For more information on the incidence and management of infections in patients enrolled in the MajesTEC-1 trial, read our previous Multiple Myeloma Hub article.
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Teclistamab: real-world safety and efficacy
Table 1. Baseline patient characteristics and reasons for MajesTEC-1 ineligibility*
Characteristic, % (unless otherwise specified) |
N = 106 |
---|---|
Median age, years |
66.5 |
Median time since diagnosis, years |
5.5 |
Median number of prior lines of therapy, n |
6 |
>4 prior lines of therapy |
80 |
R-ISS stage III |
31 |
ECOG performance status ≥2 |
33 |
EMD |
42 |
High-risk cytogenetics |
59 |
Prior BCMA therapy |
53 |
Reasons for MajesTEC-1 ineligibility, % (unless otherwise specified) |
n = 88 |
Prior anti-BCMA therapy |
53 |
Poor performance status (ECOG ≥2) |
33 |
Any baseline cytopenia |
31 |
Renal dysfunction |
13 |
Liver dysfunction |
5 |
Cardiac dysfunction |
4 |
Plasma cell leukemia |
2 |
Amyloidosis |
1 |
CNS involvement |
4 |
ASCT ≤12 weeks |
1 |
ASCT, autologous stem cell transplant; BCMA, B-cell maturation antigen; CNS, central nervous system; ECOG, |
Figure 1. Real-world efficacy results*
CR, complete response; ORR, overall response rate; PR, partial response; VGPR, very good PR.
*Adapted from Dima, et al.1
Table 2. ORR according to previous therapy*
Type of previous therapy |
ORR |
Number of patients |
---|---|---|
ADC |
50 |
10 |
CAR T cell |
57 |
33 |
ADC + CAR T cell |
80 |
10 |
ADC + other |
33 |
3 |
ADC, antibody-drug conjugate; CAR T-cell, chimeric antigen receptor T-cell; ORR, overall response rate. |
Figure 2. Any-grade hematological adverse events at Day 30 and Day 90*
*Adapted from Dina, et al.1
Teclistamab demonstrated efficacy and favorable tolerability in the real-world setting, especially in patients with heavily pretreated relapsed/refractory disease. The ORRs were similar to those reported in the MajesTEC-1 trial. However, lower rates of complete response or better were seen in this setting. Extramedullary disease and ECOG performance score independently predicted worse OS and PFS. Incidences of severe cytokine release syndrome and immune cell-associated neurotoxicity were minimal. Future research should explore the risk-benefit balance of shorter treatment durations and potential cessation in patients achieving deep remission to support immune recovery.
This educational resource is independently supported by Johnson & Johnson . All content is developed by SES in collaboration with an expert steering committee; funders are allowed no influence on the content of this resource.
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