Teclistamab: First Approval

Kang, Connie

doi:10.1007/s40265-022-01793-1

Cited by 56 publications

(35 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Furthermore, several studies showed that the R/R MM patients who had experienced relapse after anti-BCMA CAR-T cell therapy could also benefit from carfilzomib-based therapy, venetoclax-based therapy, and selinexor-based therapy (132)(133)(134)136). In addition, T cell redirecting bispecific antibodies, such as Cevostamab and Talquetamab, have also proved to be feasible salvage treatment after anti-BCMA CAR-T cell therapy and able to induce durable responses (137)(138)(139). Moreover, a phospholipid-drug complex Iopofosine I-131 could also achieve clinical responses in R/R MM patients who had failed in prior anti-BCMA therapy (140).…”

Section: Subsequent Anti-myeloma Therapy After Car-t Therapymentioning

confidence: 99%

CAR-T cell therapy in multiple myeloma: Current limitations and potential strategies

Zhang

Zhang²,

Lan³

et al. 2023

Front. Immunol.

View full text Add to dashboard Cite

Over the last decade, the survival outcome of patients with multiple myeloma (MM) has been substantially improved with the emergence of novel therapeutic agents, such as proteasome inhibitors, immunomodulatory drugs, anti-CD38 monoclonal antibodies, selective inhibitors of nuclear export (SINEs), and T cell redirecting bispecific antibodies. However, MM remains an incurable neoplastic plasma cell disorder, and almost all MM patients inevitably relapse due to drug resistance. Encouragingly, B cell maturation antigen (BCMA)-targeted chimeric antigen receptor T (CAR-T) cell therapy has achieved impressive success in the treatment of relapsed/refractory (R/R) MM and brought new hopes for R/R MM patients in recent years. Due to antigen escape, the poor persistence of CAR-T cells, and the complicated tumor microenvironment, a significant population of MM patients still experience relapse after anti-BCMA CAR-T cell therapy. Additionally, the high manufacturing costs and time-consuming manufacturing processes caused by the personalized manufacturing procedures also limit the broad clinical application of CAR-T cell therapy. Therefore, in this review, we discuss current limitations of CAR-T cell therapy in MM, such as the resistance to CAR-T cell therapy and the limited accessibility of CAR-T cell therapy, and summarize some optimization strategies to overcome these challenges, including optimizing CAR structure, such as utilizing dual-targeted/multi-targeted CAR-T cells and armored CAR-T cells, optimizing manufacturing processes, combing CAR-T cell therapy with existing or emerging therapeutic approaches, and performing subsequent anti-myeloma therapy after CAR-T cell therapy as salvage therapy or maintenance/consolidation therapy.

show abstract

Section: Subsequent Anti-myeloma Therapy After Car-t Therapymentioning

confidence: 99%

CAR-T cell therapy in multiple myeloma: Current limitations and potential strategies

Zhang

Zhang²,

Lan³

et al. 2023

Front. Immunol.

View full text Add to dashboard Cite

show abstract

“…Teclistamab-cqyv is the first T-cell-redirecting bispecific IgG4 antibody against both CD3 and B-cell maturation antigen (BCMA) (Moreau et al 2022 ). Teclistamab has been approved for relapsed or refractory multiple myeloma in patients who have used more than four previous treatment lines (Kang 2022b ). It received a breakthrough designation following a priority review and an accelerated approval.…”

Section: Oncologymentioning

confidence: 99%

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022

Kaykı-Mutlu

Aksoyalp

Wojnowski

et al. 2023

Naunyn-Schmiedeberg's Arch Pharmacol

View full text Add to dashboard Cite

While new drug approvals by the U.S. Food and Drug Administration (FDA) had remained stable or even increased in the first 2 years of the COVID-19 pandemic, the 37 newly approved drugs in 2022 are considerably less than the 53 and 50 new drugs approved in 2020 and 2021, respectively, and less than the rolling 10-year average of 43. As in previous years of this annual review, we assign these new drugs to one of three levels of innovation: first drug against a condition (“first-in-indication”), first drug using a novel molecular mechanism (“first-in-class”), and “next-in-class,” i.e., a drug using an already exploited molecular mechanism. We identify two “first-in-indication” (ganaxolon and teplizumab), 20 (54%) “first-in-class,” and 17 (46%) “next-in-class” drugs. By treatment area, rare diseases and cancer drugs were once again the most prevalent (partly overlapping) therapeutic areas. Other continuing trends were the use of accelerated regulatory approval pathways and the reliance on biopharmaceuticals (biologics).

show abstract

“…MsAbs can provide synergistic effects that are capable of overcoming therapeutic barriers and thus address unmet medical needs . In 2022, over 80 msAbs were subjected to clinical trials, , and 9 msAbs were approved by the authorities: catumaxomab (Removab, Trion), blinatumomab (BLINCYTO, Amgen Inc.), , emicizumab (Hemlibra, Genentech), ,− amivantamab (Rybrevant, Janssen Biotech), mosunetuzumab − (Lunsumio, Roche), tebentafusp (Kimmtrak, Immunocore), , faricimab (Vabysmo, Roche, Genentech), , teclistamab (Tecvayli, Johnson&Johnson), , and ozoralizumab (Nanozora, Taisho Pharmaceutical) . These 80 clinical candidates are engineered msAbs covering a broad spectrum of different antibody formats, and new formats are emerging frequently. − As of today, there are over 60 different multispecific antibody formats published. , With the growing therapeutic potential, however, the molecular complexity increases, thus intensifying the demand for innovative protein engineering − and analytical strategies .…”

Section: Introductionmentioning

confidence: 99%

High-Throughput and Format-Agnostic Mispairing Assay for Multispecific Antibodies Using Intact Mass Spectrometry

Ziegengeist,

Orth,

Kroll

et al. 2023

Anal. Chem.

View full text Add to dashboard Cite

Multispecific antibodies have gained significant importance in a broad indication space due to their ability to engage multiple epitopes simultaneously and to thereby overcome therapeutic barriers. With growing therapeutic potential, however, the molecular complexity increases, thus intensifying the demand for innovative protein engineering and analytical strategies. A major challenge for multispecific antibodies is the correct assembly of light and heavy chains. Engineering strategies exist to stabilize the correct pairing, but typically individual engineering campaigns are required to arrive at the anticipated format. Mass spectrometry has proven to be a versatile tool to identify mispaired species. However, due to manual data analysis procedures, mass spectrometry is limited to lower throughputs. To keep pace with increasing sample numbers, we developed a high-throughput-capable mispairing workflow based on intact mass spectrometry with automated data analysis, peak detection, and relative quantification using Genedata Expressionist. This workflow is capable of detecting mispaired species of ∼1000 multispecific antibodies in three weeks and thus is applicable to complex screening campaigns. As a proof of concept, the assay was applied to engineering a trispecific antibody. Strikingly, the new setup has not only proved successful in mispairing analysis but has also revealed its potential to automatically annotate other product-related impurities. Furthermore, we could confirm the assay to be format-agnostic, as shown by analyzing several different multispecific formats in one run. With these comprehensive capabilities, the new automated intact mass workflow can be applied as a universal tool to detect and annotate peaks in a format-agnostic approach and in high-throughput, thus enabling complex discovery campaigns.

show abstract

Teclistamab: First Approval

Cited by 56 publications

References 13 publications

CAR-T cell therapy in multiple myeloma: Current limitations and potential strategies

CAR-T cell therapy in multiple myeloma: Current limitations and potential strategies

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022

High-Throughput and Format-Agnostic Mispairing Assay for Multispecific Antibodies Using Intact Mass Spectrometry

Contact Info

Product

Resources

About