P921: Updated Efficacy and Safety Results of Teclistamab, a B-Cell Maturation Antigen X Cd3 Bispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma From Majestec-1

Martinez-Lopez, J.; Moreau, P.; Usmani, Saad Z.; Garfall, Alfred L.; Donk, N. W. van de; San-Miguel, Jesús F.; Oriol, Albert; Chari, Ajai; Karlin, Lionel; Mateos, M.V.; Popat, Rakesh; Nooka, Ajay K.; Sidana, Surbhi; Trancucci, Danielle; Verona, Raluca; Girgis, Suzette; Uhlar, Clarissa M.; Stephenson, Tara; Banerjee, Arnob; Krishnan, A.

doi:10.1097/01.hs9.0000846552.63695.9d

Cited by 2 publications

(6 citation statements)

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“…The tolerability profile of teclistamab after ≈ 9 months of follow up in MajesTEC-1 was consistent with earlier analyses, and no new safety signals were seen [14].…”

Section: Adverse Eventssupporting

confidence: 85%

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Teclistamab: First Approval

Kang

2022

Drugs

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Teclistamab (TECVAYLI ® ), a bispecific antibody that targets CD3 and B cell maturation antigen (BCMA), is being developed by Janssen Research and Development for the treatment of relapsed or refractory multiple myeloma. Teclistamab was recently granted conditional approval in the EU for the treatment of adult patients with relapsed and refractory multiple myeloma who have received three or more prior therapies (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody) and have demonstrated disease progression on the last therapy. Teclistamab was subsequently approved in the US for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody). This article summarizes the milestones in the development of teclistamab leading to this first approval for relapsed or refractory multiple myeloma.This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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“…The tolerability profile of teclistamab after ≈ 9 months of follow up in MajesTEC-1 was consistent with earlier analyses, and no new safety signals were seen [14].…”

Section: Adverse Eventssupporting

confidence: 85%

“…Updated phase 2 efficacy results (data cutoff 9 Nov 2021) were consistent with the primary analysis; the ORR was 64%, and 30% of patients achieved a CR or better [14]. The 12-month duration of response rate was 66% [14].…”

Section: Features and Properties Of Teclistamabsupporting

confidence: 62%

Teclistamab: First Approval

Kang

2022

Drugs

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“…In another phase I/II study (NCT03145181) conducted by Martinez-Lopez et al, 165 patients were administered teclistamab weekly subcutaneously at 1.5 mg/kg. The overall response rate (ORR) was 64% (105/165), with 30% (50/165) achieving CR or better [ 20 ]. A phase Ib trial (NCT04108195) assessed teclistamab in combination with daratumumab, an anti-CD38 antibody.…”

Section: Resultsmentioning

confidence: 99%

“…The median follow-up time was 4.17 months and median time to first response was 1 month [ 22 ]. In all four studies, neutropenia was the most common hematologic adverse event and CRS was the most common non-hematologic adverse event [ 19 , 20 , 21 , 22 ].…”

Section: Resultsmentioning

confidence: 99%

“…The secondary screening was performed by reviewing 265 full texts based on three predetermined inclusion criteria: (1) randomized or non-randomized clinical trials with results published, (2) age > 18, and (3) outcomes specific to RRMM patients. After excluding review articles, preclinical/preliminary studies, and observational studies, we included 18 clinical trials, reporting the outcomes of bispecific antibodies in RRMM patients ( Figure 1 ) [ 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ].…”

Section: Methodsmentioning

confidence: 99%

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The Role of Bispecific Antibodies in Relapsed Refractory Multiple Myeloma: A Systematic Review

et al. 2023

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Multiple myeloma is a heterogeneous clonal malignant plasma cell disorder, which remains incurable despite the therapeutic armamentarium’s evolution. Bispecific antibodies (BsAbs) can bind simultaneously to the CD3 T-cell receptor and tumor antigen of myeloma cells, causing cell lysis. This systematic review of phase I/II/III clinical trials aimed to analyze the efficacy and safety of BsAbs in relapsed refractory multiple myeloma (RRMM). A thorough literature search was performed using PubMed, Cochrane Library, EMBASE, and major conference abstracts. A total of 18 phase I/II/III studies, including 1283 patients, met the inclusion criteria. Among the B-cell maturation antigen (BCMA)-targeting agents across 13 studies, the overall response rate (ORR) ranged between 25% and 100%, with complete response/stringent complete response (CR/sCR) between 7 and 38%, very good partial response (VGPR) between 5 and 92%, and partial response (PR) between 5 and 14%. Among the non-BCMA-targeting agents across five studies, the ORR ranged between 60 and 100%, with CR/sCR seen in 19–63%, and VGPR in 21–65%. The common adverse events were cytokine release syndrome (17–82%), anemia (5–52%), neutropenia (12–75%), and thrombocytopenia (14–42%). BsAbs have shown promising efficacy against RRMM cohorts with a good safety profile. Upcoming phase II/III trials are much awaited, along with the study of other agents in concert with BsAbs to gauge response.

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P921: Updated Efficacy and Safety Results of Teclistamab, a B-Cell Maturation Antigen X Cd3 Bispecific Antibody, in Patients With Relapsed/Refractory Multiple Myeloma From Majestec-1

Cited by 2 publications

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Teclistamab: First Approval

Teclistamab: First Approval

The Role of Bispecific Antibodies in Relapsed Refractory Multiple Myeloma: A Systematic Review

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