FDA update | approval of teclistamab-cqyv for the treatment of relapsed or refractory multiple myeloma

On October 25, 2022, the US Food and Drug Administration (FDA) accelerated the approval of the B cell maturation antigen (BCMA)/CD3 bispecific T cell adaptor teclistamab-cqyv for adult patients with relapsed or refractory multiple myeloma who have received at least four prior fourth-line therapies, including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies.

The efficacy and safety of teclistamab-cqyv were studied in the clinical study of MajesTEC-1 (NCT03145181; NCT04557098), which was a single-arm, multi-cohort, open-label, multicenter study
.
The effective population consisted of 110 patients who had received at least three prior third-line therapies, including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies, and who had not previously received targeted BCMA
.

The main efficacy measure was the overall response rate (ORR), which was determined
by the Independent Review Committee using the 2016 criteria of the International Myeloma Working Group.
The results showed that the ORR was 61.
8% (95% CI: 52.
1, 70.
9).

The median follow-up of remitters was 7.
4 months, with an estimated sustained response (DOR) rate of 90.
6% (95% CI: 80.
3%, 95.
7%) at six months and an estimated DOR rate of 66.
5% (95% CI: 38.
8%, 83.
9%)
at nine months.

The prescribing information for teclistamab-cqyv includes boxed warnings
for fatal cytokine release syndrome (CRS) and neurotoxicity, including immune effector cell-associated neurotoxicity syndrome [ICANS].
Among patients treated with teclistamab-cqyv at recommended doses, CRS developed in 72%, neurotoxicity in 57% and ICANS
in 6%.
Grade 3 CRS occurred in 0.
6% of patients and grade 3 or 4 neurotoxicity
in 2.
4% of patients.
The most common adverse effects (≥20%) were fever, CRS, musculoskeletal pain, injection site reactions, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea
.
The most common grade 3 to 4 laboratory abnormalities (≥20%) are lymphopenia, neutropenia, leukopenia, decreased hemoglobin, and thrombocytopenia
.

The recommended dose for teclistamb-cqyv is 0.
06 mg/kg subcutaneously on day 1, 0.
3 mg/kg subcutaneously on day 4, 1.
5 mg/kg subcutaneously on day 7, followed by 1.
5 mg/kg weekly until disease progression or intolerable toxicity
.

Reference sources:

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