Lancet: The bispecific antibody Teclistamab is expected to become a new treatment for relapsed/refractory multiple myeloma!

Relapsed or refractory multiple myeloma requires the development of new treatment methods, and B cell maturation antigen (BCMA) is a potential new and effective target
.

Teclistamab is a bispecific antibody that can simultaneously bind BCMA and CD3 to guide T cells to pool in multiple myeloma cells

The purpose of the MajesTEC-1 study is to evaluate the safety, tolerability and preliminary efficacy of teclistamab in patients with relapsed or refractory multiple myeloma
.

This is an open-label, single-arm phase 1 trial that recruits patients with multiple myeloma who are relapsed, refractory, or unacceptable to existing treatment options
.

Teclistamab intravenously (0.

From June 8, 2017 to March 29, 2021, a total of 219 patients were screened , of which 157 were recruited to receive at least one dose of Teclistamab (intravenous n=84, subcutaneous n=73)
.

The recommended phase 2 dose was determined as follows: after a gradual increase in the dose of 60 μg/kg and 300 μg/kg, subcutaneous administration of 1500 μg/kg (1/week), 40 patients used the recommended phase 2 dose (median Followed up for 6.

Screening the recommended dosage is determined as 2, after 60 μg / kg and 300 μg kg to gradually increase / dose after subcutaneous administration of 1500 μg / kg (1 / week), the recommended dosage is determined to be 2 through 60 μg / kg and 300 μg/kg gradually increase the dose, subcutaneously administer 1500 μg/kg (1/week),

Adverse reactions

Adverse reactions

In the first part, no dose-limiting toxicity occurred in patients treated with the recommended phase 2 dose
.

Among the 40 patients treated with the recommended phase 2 dose, the most common adverse reactions requiring emergency treatment were cytokine release syndrome (28 cases [70%], grade 1/2) and neutropenia (26 Cases [65%], of which 16 cases were grade 3/4)

The most common adverse reactions requiring emergency treatment were cytokine release syndrome (28 cases [70%], grade 1/2) and neutropenia (26 cases [65%], of which 16 cases were grade 3/4 ) The most common adverse reactions requiring emergency treatment were cytokine release syndrome (28 cases [70%], grade 1/2) and neutropenia (26 cases [65%], of which 16 cases were 3/4 class)

Mitigation

Mitigation

The 40 patients treated with the recommended phase 2 dose had an overall response rate of 65%; 58% of patients achieved at least a good partial response
.

The median duration of remission was not reached in patients treated with the recommended phase 2 dose

Teclistamab plasma concentration changes

Teclistamab plasma concentration changes

When treated with the recommended phase 2 dose, the exposure level of teclistamab was maintained above the target level, and continuous T cell activation was also observed
.

In conclusion, Teclistamab is a new type of treatment for relapsed/refractory multiple myeloma
.

When treated with the recommended phase 2 dose, Teclistamab showed encouraging efficacy, long-lasting remission and good tolerability, which supports further clinical trials for verification

Teclistamab is a new type of treatment for relapsed/refractory multiple myeloma

Original source:

Saad Z Usmani, et al.

Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, singlearm, phase 1 study in this message