On December 27, 2023, Targeted Oncology published an article on the impact of the Majestec-1 trial in patients with refractory multiple myeloma (RRMM). This article shows that teclistamab (trade name: tecvayli), a bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3 receptor, is used inRefractory multiple myelomashows a strong curative effect.
Previously, on October 25, 2022, the U.S. FDA hasAccelerated approvalsTeclistamab is marketed for patients with refractory multiple myeloma. These patients have received at least 4 or more pro-production** products, including immunomodulators, proteasome inhibitors, and anti-CD38 antibodies. On August 24 of the same year, teclistamab was approved for marketing by the European Union for the first time.
Teclistamab is a "first-in-class" bispecific antibody that excites T cells to kill tumor cells by recruiting CD3-positive T cells near BCMA-expressing myeloma cells. B cell maturation antigen (BCMA) is a membrane protein of a member of the tumor necrosis factor (TNF) receptor superfamily that is widely expressed on multiple myeloma (MM) cells and almost absently in normal cells. Therefore, BCMA CD3 bispecific antibody can effectively "recruit" T cells to this target lesion area and activate T cellsKills cancer cells with high expression of BCMA
Caption: Mechanism of action of teclistamab.
Product Name:tecvayli
Common Name:teclistamab
Codename:jnj-64007957
Target:bcma/cd3
Manufacturer:Janssen
First approved in the United States:October 2022.
Approved for the first time in China:Not yet approved.
Specifications:30mg/3ml (10mg/mlmg/1.7ml (90mg/ml)
Approved Indications:Refractory multiple myeloma
Recommended Dosage:The escalating dose is 006 mg kg and 03 mg kg, then 1. once a week5 mg kg until disease progression or unacceptable toxicity.
Storage conditions:Store refrigerated at 2°C and 8°C.
Clinical data
In this Phase I II Majestec-1 trial, the safety and efficacy of teclistamab in patients with refractory multiple myeloma were evaluated.
of the testPrimary endpointis the objective response rate (ORR).Key secondary endpointsIncluding: duration of response (DOR), progression-free survival (PFS), overall survival (OS), and pharmacokinetics.
Baseline characteristics of enrolled patients included: in the trialAbout 15% of patients are 75 years of age or older, which indicates that it is quite well tolerated;High-risk and difficult** patients: extramedullary disease accounts for about 17%, and high-risk cytogenetics accounts for about 26%;These are patients who have undergone extensive pretreatment, with the majority (about 74%) having more than 4 prior experiences**The median number of previous ** lines was 5。The majority of patients (818%) underwent an autologous stem cell transplant.
The data showed that the objective response rate (ORR) wasand have a long-lasting reaction. In addition, patients with complete remissionSustained reaction。The median duration of response (DOR) was about:18 months, median progression-free survival (PFS) was11.3 months, median overall survival (OS) is approximately18 months。It is worth mentioning that ORR is consistent in high-risk cytogenetics and multiple refractory patients.
Security
In terms of safety, most patients who received teclistamab** had varying degreesCytopenias。Grade 3 and 4 cytopenias are less common (more common than grade 1 and 2), butNeutropeniaVery common (709% of any grade AE642% for grade 3 and 4), which also leads to an increased risk of infection. Sixty-three percent of patients required interruption of ongoing dosing due to adverse events (AEs).
In addition,Cytokine release syndromeThe incidence of CRS (CRS) is high at 72%, but the incidence of grade 3 4 CRS is only about 1%. Neurotoxic eventsThe incidence was 145% (any grade), including ICANS (immune effector cell-associated neurotoxicity syndrome).
Summary
Overall, teclistamab has significant anti-tumor efficacy in patients with ** and refractory multiple myeloma, and the safety profile is manageable.
Reference**:ImportantInta Health's ***Global Good Drug Information] All article information is for reference only, specific**Follow your doctor's advice