Plain Language Summary
What is this summary about?
This summary describes infection and immune cell data of participants receiving talquetamab for relapsed/refractory multiple myeloma (RRMM) in the MonumenTAL-1 study.
What were the results?
Almost 60% of participants receiving talquetamab 0.4 mg/kg once weekly, 66% of participants receiving 0.8 mg/kg once every other week, and about 75% of participants with previous T-cell redirection therapy with either talquetamab dose, experienced infections. Respiratory infections were most common. Some participants experienced severe infections (about 20%: 0.4 mg/kg; 15%: 0.8 mg/kg; 30%: previous T-cell redirection therapy), most often in early treatment cycles.
Few participants experienced opportunistic infections, which may occur in people with weakened immune systems (3.5%: 0.4 mg/ kg; 5.5%: 0.8 mg/kg; 5.9%: previous T-cell redirection therapy). Five of 339 participants died due to infections. The risk of infections was lower after 3 months of talquetamab treatment. Few participants received donor antibodies (intravenous immunoglobulin) after talquetamab treatment (around 10%: 0.4 mg/kg; 7%: 0.8 mg/kg; 9%: previous T-cell redirection therapy).
What do the results of this study mean?
Participants receiving talquetamab experienced lower rates of severe infection than other studied B-cell maturation antigen-targeting bispecific antibodies. Their immune systems could fight infections, showing that talquetamab treatment keeps the immune system working for participants with RRMM.
Clinical trial number: NCT03399799
Clinical trial number: NCT04634552
KEYWORDS: clinical trial, GRPC5D, Infections, Lay Summary, MonumenTAL-1 plain language summary, relapsed or refractory multiple myeloma, talquetamab
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Disclosure statement
Carolina Schinke received honoraria from MJH Life Sciences, OncLive, and Pfizer; serves on an advisory board for Johnson & Johnson; and receives consulting fees from Johnson & Johnson. Paula Rodríguez-Otero has no conflicts to disclose. Niels W.C.J. van de Donk has received research support from Amgen, BMS, Celgene, Cellectis, Novartis, and Johnson & Johnson; and serves on advisory boards for AbbVie, Adaptive, Amgen, Bayer, BMS, Celgene, Johnson & Johnson, Kite Pharma, Merck, Novartis, Oncopeptides, Pfizer, Roche, Sanofi, Servier, and Takeda, all paid to institution. Brea Lipe has served on an advisory board for AbbVie, GSK, Karyopharm, Johnson & Johnson, Pfizer, and Sanofi; and received consulting fees from AbbVie, GSK, Karyopharm, Johnson & Johnson, Pfizer, and Sanofi. Noa Lavi has no conflicts to disclose. Leo Rasche has received honoraria from BMS, GSK, Johnson & Johnson, Pfizer, Roche, and Sanofi; is a member of a board of directors or advisory committee for Amgen, BMS, Johnson & Johnson, Pfizer, and Sanofi; is a consultant for Amgen, BMS, GSK, Johnson & Johnson, Pfizer, and Sanofi; and has received research funding from BMS and Skyline Dx. Diana Cortes-Selva, Tara Masterson, Sheetal Khedkar, Jaszianne Tolbert, Colleen Kane, Ibrahim Saber, and Christoph Heuck are employees of Johnson & Johnson and may hold stock, stock options, or equity in Johnson & Johnson. Ajai Chari is a consultant for AbbVie, Adaptive, Amgen, Antengene, BMS, Forus, Genentech/Roche, GSK, Johnson & Johnson, Karyopharm, Millenium/Takeda, and Sanofi; and has received research funding from Johnson & Johnson. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Summary prepared by Rania Kairouz-Wahbe, PhD, and Renee Elizabeth Granger, PhD, of Envision Medical Communications, and funded by Johnson & Johnson. The original authors of the full article were involved in preparing this summary.
Reviewer disclosures
Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.
A reviewer on this manuscript has disclosed grants from Janssen, Pfizer, Bristol Myers Squibb, Sanofi, GSK, AbbVie and honoraria from Janssen, Bristol Myers Squibb, Sanofi, Ono, Pfizer, CSL Behring. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.
Funding
This manuscript was funded by Johnson & Johnson. The funder was involved in study design, data collection and analysis, decision to publish, and preparation of the manuscript.