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2024-06-11T14:56:03.000Z

Talquetamab + pomalidomide for the treatment of RRMM: Preliminary safety and efficacy from MonumenTAL-2

Jun 11, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in relapsed/refractory multiple myeloma.

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Pomalidomide is an established immunomodulatory drug for the treatment of multiple myeloma (MM), which directly inhibits myeloma cell growth while enhancing immune activity.1 As part of the MonumenTAL-2 trial,  talquetamab is under evaluation for efficacy and safety in the treatment of MM in combination with other agents, including pomalidomide.1

Here, we summarize an oral abstract by Matous et al.1 presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition on the safety and preliminary efficacy results from the talquetamab + pomalidomide arm of the MonumenTAL-2 trial.

Study design1

  • MonumenTAL-2 (NCT05050097) is an open-label, non-randomized phase Ib clinical trial evaluating the safety and efficacy of talquetamab combinations, including lenalidomide, daratumumab-lenalidomide, and pomalidomide.
  • Patients with relapsed/refractory MM with two or more prior lines of therapy are eligible.
  • Patients were treated with either:
    • 0.4 mg/kg subcutaneous talquetamab once weekly plus pomalidomide; or
    • 0.8 mg/kg subcutaneous talquetamab every two weeks plus pomalidomide.

Key findings1

Safety1

  • Dose reductions due to toxicities were recorded in 34.3% of patients associated with talquetamab and 45.7% with pomalidomide.
  • A death was recorded in one of the 11.4% of patients who discontinued treatment and was attributed to a pulmonary embolism.
  • The rates of adverse events were comparable with the safety profiles of talquetamab and pomalidomide as individual agents (Table 1)
  • Infections were common, occurring in 80% of patients at any grade.
    • Pneumonia and upper respiratory tract infections were the most frequent infections; however, rates of Grade 3/4 presentations were low (Table 1).

TEAE of interest, %

All patients
(N = 35)

Any grade

Grade 3/4

Hematologic

 

 

              Neutropenia

62.9

54.3

              Anemia

37.1

25.7

              Thrombocytopenia

28.6

20

Non-hematologic

 

 

              Taste related

85.7

N/A

              Skin related

74.3

5.7

              Nail related

68.6

0

              CRS

74.3

2.9

Infections

80

22.9

              Pneumonia

22.9

14.3

              Upper RTI

22.9

2.9

              COVID-19

17.1

2.9

COVID, coronavirus disease; CRS, cytokine release syndrome; RTI, respiratory tract infection; TEAE, treatment-emergent adverse event.
*Data from Matous, et al.1

Efficacy1

  • Overall response rates were numerically higher in the 0.4 mg/kg cohort (Figure 1)
  • Response was consistent across patient subgroups including those who were chimeric antigen receptor T cell exposed, pomalidomide exposed, have extramedullary disease, and those with high-risk disease.
  • In the 0.4 mg/kg and 0.8 mg/kg cohorts, respectively:
    • 9-month progression-free survival rate was 93.8% and 75.5%.
    • 9-month duration of response rate was 100% and 83.9%.

Figure 1. Overall response rates in the talquetamab + pomalidomide arm of MonumenTAL-2* 

CR, complete response; ORR, overall response rate; Pom, pomalidomide; PR, partial response; QW, every week; Q2W, every two weeks; sCR, stringent complete response; Tal, talquetamab; VGPR, very good partial response.
*Adapted from Matous, et al.1

Key learnings

  • Preliminary safety and efficacy data from the MonumenTAL-2 clinical trial provide evidence for the combination talquetamab and pomalidomide as a feasible option for further investigation in relapsed/refractory MM.
  • The safety profile of talquetamab + pomalidomide was comparable with that of the individual agents.
  • Initial response rates in this small cohort are promising, but more data are required to draw any conclusions.

  1. Matous J, Biran N, Perrot A, et al. Talquetamab + pomalidomide in patients with relapsed/refractory multiple myeloma: Safety and preliminary efficacy results from the phase 1b MonumenTAL-2 study. Oral abstract #1014. 65th American Society of Hematology Annual Meeting and Exposition; Dec 9–12, 2023; San Diego, US.

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