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2024-01-19T17:26:23.000Z

Teclistamab: real-world safety and efficacy

Jan 19, 2024
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Learning objective: After reading this article, learners will be able to cite real-world safety and efficacy data for teclistamab in patients with relapsed/refractory multiple myeloma.

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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.

Study design1

  • The full study design of the MajesTEC-1 trial was reported in this Multiple Myeloma Hub article.
  • This study was a retrospective multicenter analysis of the expanded-access program for teclistamab, which took place between August 2022 and August 2023.
  • All patients had received at least one full dose of teclistamab as of July 15, 2023
  • The data cutoff was August 15, 2023.

Results1

  • The baseline patient characteristics and reasons for MajesTEC-1 ineligibility are shown in Table 1.

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,
European Cooperative Oncology Group; EMD, extramedullary disease; R-ISS, Revised International Scoring
System.
*Adapted from Dima, et al.1

  • A total of 56 patients had received prior B-cell maturation antigen therapy

Efficacy1

  • The real-world efficacy results of teclistamab are shown in Figure 1.

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

  • The overall response rates (ORR) according to the type of previous therapy are shown in Table 2.

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.
*Adapted from Dina, et al.1

  • Median follow-up time was 3.8 months.
  • Median progression-free survival (PFS) was 5.4 months.
  • Median overall survival (OS) was not reached:
    • 6-month OS rate 70%; and
    • 10-month OS rate 67%.
  • Multivariate analysis revealed several factors were independently associated with inferior ORR; these were:
    • European Cooperative Oncology Group (ECOG) performance score ≥2;
    • extramedullary disease; and
    • >4 prior lines of therapy.
  • Factors independently associated with inferior PFS were:
    • ECOG performance score ≥2;
    • extramedullary disease; and
    • age ≤70 years.

Safety1

  • Cytokine release syndrome of any grade was experienced by 64% of patients, with a median duration of 1 day.
  • Immune effector cell-associated neurotoxicity of any grade was experienced by 14% of patients, with a median duration of 2 days.
  • The percentage of patients who experienced hematological adverse events of any grade at Days 30 and 90 are shown in Figure 2.

Figure 2. Any-grade hematological adverse events at Day 30 and Day 90*

*Adapted from Dina, et al.1

  • A total of 39 infections were reported, of which 46% were serious.
  • In total, 29 patients died during the study.
    • The main cause of death was disease progression (86%).

Conclusion1

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.

  1. Dima D, Davis J, Ahmed N, et al. Real-world safety and efficacy of teclistamab for patients with heavily pretreated relapsed-refractory multiple myeloma. Abstract #91. 65th American Society of Hematology Annual Meeting and Exposition; Dec 9, 2023; San Diego, US.

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