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Teclistamab for relapsed or refractory multiple myeloma - Australian Prescriber
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Initial step-up dosing with pretreatment medications is required to manage the risk of adverse effects such as cytokine release syndrome."> <meta property="article:published_time" content="2025-02-18T00:00:00+11:00"> <!-- 2023-08-22T00:00:00+11:00 --> <meta property="og:url" content="https://australianprescriber.tg.org.au/articles/teclistamab-for-relapsed-or-refractory-multiple-myeloma.html"> <meta property="og:site_name" content="Australian Prescriber"> <meta name="twitter:card" content="summary"> <link href="https://fonts.googleapis.com/css?family=Montserrat:300,400,500,600,700" rel="stylesheet"> <link rel="stylesheet" href="https://cdnjs.cloudflare.com/ajax/libs/font-awesome/4.7.0/css/font-awesome.min.css"> <link href="/css/all.css" rel="stylesheet" type="text/css" media="all"> <script src="https://www.google.com/recaptcha/api.js" async="" defer=""></script> <meta name="citation_doi" content="10.18773/austprescr.2025.001"> <meta name="citation_title" content="Teclistamab for 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Aust Prescr 2025;48:29-30.<a href="https://doi.org/10.18773/austprescr.2025.001"><span>https://doi.org/10.18773/austprescr.2025.001</span></a> <p class="download-ris-file"> <a href="/download-ris-file/austprescr.2025.001.ris" download="austprescr.2025.001.ris" class="share strong-pink"> <span class="icon-icn-download-new"></span> <span class="color-dark-violet text-download">Download .RIS file</span> </a> </p> </div> </div> </div> </div> </li> </ul> </div> </div> </div> </div> </section> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script> <script type="text/javascript" src="https://d1bxh8uas1mnw7.cloudfront.net/assets/embed.js"></script> </div> <div class="panel panel-tab w-slider"> <span class="flag-tabs"></span> <div class="tabs full-border strong-pink"> <div class="inner"> <nav role="navigation" aria-label="Australian Prescriber Article details"> <ul class="ul-tabs" data-tab-nav=""> <li><a href="#article">Article</a> </li> </ul> </nav> </div> </div> <div data-tab-content=""> <div class="panel-tab-content "> <div class="inner"> <div class="layout-list large"> <div class="layout-item"> <div class="subscribe on-ipad-and-down w-margin-bottom"> <a target="_blank" href="/subscribe"> <ul> <li><span class="icon-icn-newsletter heading-color"></span> </li> <li> <div class="heading-color"> <p><strong>Subscribe to</strong></p> <p></p><strong class="color-strong-pink">Australian Prescriber</strong> <p></p> </div> </li> </ul> </a> </div> <div class="topic-template"> <!-- _topic_template_ --> <div class="wgSection tgmaincontent topic-wrap" data-hash=""> <span class="openning section count: 1 currentSection : "></span> <div data-section-count="1" class="strong-pink"> <div class="panel panel-text-with-list is-list strong-pink "> <div class="inner"> <div class="list"> <div class="item"> <div class="des tgcontent"> <div class="panel panel-text-with-list wgPdf is-list strong-pink" data-box-widget="" id=""> <div class="inner"> <div class="des"> <div class="box-widget bg-light-grayish-blue"> <table class="MsoTableGrid"> <tbody> <p><strong>Active ingredient</strong><strong>:</strong> teclistamab</p> <p><strong>Brand name (sponsor)</strong><strong>:</strong> Tecvayli (Janssen-Cilag)</p> <p><strong>Presentation</strong><strong>:</strong> 3 mL vials containing 30 mg teclistamab and 1.7 mL vials containing 153 mg teclistamab</p> <p><strong>Route of administration</strong><strong>:</strong> subcutaneous injection</p> <p><strong>Approved indication</strong><strong>:</strong> treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody</p> </tbody> </table> </div> </div> </div> </div> <br> <p><b>Background: </b><br>Multiple myeloma is a B-cell malignancy involving the proliferation of abnormal plasma cells in the bone marrow and the production of paraproteins. Bone lesions, renal dysfunction, anaemia and hypercalcaemia are common presentations. While multiple myeloma is incurable, survival has been improved by treatments such as immunomodulators, proteasome inhibitors, monoclonal antibodies and stem cell transplantation. Despite treatment, multiple myeloma will relapse in most patients and ultimately has a poor prognosis. Teclistamab is a new treatment option for patients with relapsed or refractory disease who have received at least 3 previous therapies.</p> <p><b>Mechanism of action: </b><br>Teclistamab is a genetically engineered immunoglobulin G bispecific antibody that binds to B-cell maturation antigen on multiple myeloma cells and CD3 receptors on T cells. This binding results in T-cell activation, the release of cytokines and lysis of the multiple myeloma cells.<sup><a href="#r11">1</a></sup></p> <p><b>Clinical trials: </b><br>At present, evidence for the efficacy of teclistamab is limited. Some results have been published from an ongoing single-arm, open-label, phase 1 to 2 trial<i> </i>(MajesTEC-1).<sup><a href="#r12">2</a>,<a href="#r13">3</a></sup> Having established the treatment dose in phase 1,<sup><a href="#r12">2</a></sup> the phase 2 part of the trial included 165 patients.<sup><a href="#r13">3</a></sup> They had previously been treated with a median of 5 therapies for relapsed or refractory multiple myeloma and more than 80% had received a stem cell transplant. At a median follow-up of 14.1 months, 104 patients (63.0%) had at least a partial response to treatment, according to the criteria of the International Myeloma Working Group. This included 65 (39.4%) complete responses. The median duration of response was 18.4 months with a progression-free survival of 11.3 months. Median overall survival was 18.3 months based on data from 97 patients.<sup><a href="#r13">3</a></sup><sup><a href="#r1"></a></sup></p> <p>A 2024 report on MajesTEC-1 trial data indicated that, after a median follow-up of 30.4 months, the overall response rate remained at 63.0%, with a median overall survival of 22.2 months.<sup><a href="#r14">4</a></sup><sup><a href="#r1"></a></sup>The full, peer-reviewed results of the trial are not yet available. The trial is anticipated to be completed in 2025.</p> <p><b>Adverse effects: </b><br>All patients in the trial experienced adverse events, including the effects of the disease (e.g. anaemia) and those of the drug. Haematological abnormalities were very common, including neutropenia (70.9%), anaemia (52.1%) and thrombocytopenia (40.0%). Hypogammaglobulinaemia occurred in 74.5% of patients, and infections (e.g. pneumonia, COVID-19) in 76.4% of patients. Injection-site reactions were also common (36.4%). During the trial, 68 patients died with 5 of those deaths considered to be related to teclistamab.<sup><a href="#r13">3</a></sup></p> <p>Due to teclistamab’s mechanism of action, there is a risk of cytokine release syndrome (72.1% of trial patients) which can be life-threatening, although most occurrences in the trial were mild to moderately severe and resolved. The median time to onset of cytokine release syndrome was 2 days.<sup><a href="#r13">3</a></sup> Cytokine release syndrome is more likely to occur at the start of treatment and so all patients should receive pretreatment medications during step-up dosing. </p> <p><b>Dosage and administration: </b><br>Treatment with teclistamab requires an initial step-up dosing schedule of 3 subcutaneous injections over about 5 days, followed by once-weekly doses of 1.5 mg/kg until disease progression or unacceptable toxicity.<sup><a href="#r15">5</a></sup> </p> <p>Pretreatment medications, including a corticosteroid, an antihistamine and an antipyretic, should be administered before each step-up dose to reduce the risk of cytokine release syndrome. Patients should be monitored daily and remain close to a healthcare facility for 48 hours after receiving a step-up dose.</p> <p><b>Precautions: </b><br>Viruses such as hepatitis B and herpes zoster may be reactivated. Antiviral prophylaxis should be considered as per local institutional guidelines. Live vaccines should be avoided from 4 weeks before treatment until 4 weeks after treatment. Because of the risk of hypogammaglobulinaemia and neutropenia, measurement of immunoglobulin concentrations and complete blood count at baseline and during treatment are recommended.<sup><a href="#r15">5</a></sup></p> <p><b>Practice points: </b><br>Hepatic and renal impairment are unlikely to have a significant effect, but data are sparse. Although no drug interaction studies have been performed, there may be a greater risk of drug interactions during step-up dosing. Monitoring for toxicity or therapeutic drug monitoring is suggested in the first week of treatment in patients taking concomitant cytochrome P450 substrate drugs with a narrow therapeutic range.<sup><a href="#r15">5</a></sup> </p> <p><b>Place in therapy:</b><br> Teclistamab has provisional approval for use in Australia. Indirect comparisons suggest patients with relapsed or refractory multiple myeloma are more likely to respond to teclistamab than other current therapies;<sup><a href="#r16">6</a></sup><sup><a href="#r1"></a></sup>however, this will need to be confirmed in controlled trials. More data are emerging on the potential use of teclistamab in combination with other drugs, such as <a href="https://australianprescriber.tg.org.au/articles/lenalidomide.html" target="_self">lenalidomide</a>,<sup><a href="#r17">7</a>,<a href="#r18">8</a></sup> and as monotherapy earlier in the course of multiple myeloma.<sup><a href="#r19">9</a></sup> </p> <p><i>This new drug comment was finalised on 5 December 2024.</i></p> <p>At the time this new drug comment was prepared, the Australian Public Assessment Report was available from the Therapeutic Goods Administration. The sponsor did not provide the clinical evaluation report.<b><br clear="all"> </b></p> <span class="line large bg-strong-pink"> </span> <div class="wgSection topic-wrap tgfeedback nosafetyupdate" data-hash=""> <span class="openning section count: 2 currentSection : "></span> <div data-section-count="2" class="strong-pink"> <div class="panel panel-text-with-list is-list strong-pink "> <div class="inner"> <div class="list"> <div class="item"> <div class="des"> <p>Australian Prescriber welcomes <a tabindex="0" href="/contact-us.html">Feedback</a>.</p> </div> </div> </div> </div> </div> </div> <span class="line large bg-strong-pink nosafetyupdate"> </span> </div> <section class="wgSection topic-wrap nosafetyupdate tgreferences" data-name="References" data-hash="references"> <span class="openning section count: 3 currentSection : References"></span> <div data-section-count="3" class="strong-pink"> <div class="panel panel-text-with-list is-list strong-pink wgReference" data-references=""> <div class="inner"> <div class="item"> <h2 class="color-strong-pink">References</h2> <div class="des ol-strong-pink"> <ol class="tgreferences"> </ol> </div> </div> </div> </div> </div> </section> <ol class="EndNote1 EndNoteInOL"> <li id="r11"><a href="https://www.tga.gov.au/resources/auspar/auspar-tecvayli" class="link strong-pink small-weight no-border" target="_blank" tabindex="0"><u class="txt">Therapeutic Goods Administration. Australian Public Assessment Report for Tecvayli. Department of Health and Aged Care; 2024. [cited 2024 Oct 31]</u><span class="icon-icn-external-link"></span></a></li> <li id="r12"><a href="https://doi.org/10.1016/S0140-6736(21)01338-6" class="link strong-pink small-weight no-border" target="_blank" tabindex="0"><u class="txt">Usmani SZ, Garfall AL, van de Donk N, Nahi H, San-Miguel JF, Oriol A, et al. Teclistamab, a B-cell maturation antigen x CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet 2021;398:665-74.</u><span class="icon-icn-external-link"></span></a></li> <li id="r13"><a href="https://doi.org/10.1056/NEJMoa2203478" class="link strong-pink small-weight no-border" target="_blank" tabindex="0"><u class="txt">Moreau P, Garfall AL, van de Donk N, Nahi H, San-Miguel JF, Oriol A, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med 2022;387:495-505.</u><span class="icon-icn-external-link"></span></a></li> <li id="r14"><a href="https://doi.org/10.1200/JCO.2024.42.16_suppl.7540" class="link strong-pink small-weight no-border" target="_blank" tabindex="0"><u class="txt">Garfall AL, Nooka AK, van de Donk NWCJ, Moreau P, Bhutani M, Oriol A, et al. Long-term follow-up from the phase 1/2 MajesTEC-1 trial of teclistamab in patients with relapsed/refractory multiple myeloma. J Clin Oncol 2024;42:7540. https://doi.org/10.1200/JCO.2024.42.16_suppl.7540</u><span class="icon-icn-external-link"></span></a></li> <li id="r15"><a href="https://www.tga.gov.au/resources/artg/387621" class="link strong-pink small-weight no-border" target="_blank" tabindex="0"><u class="txt">Therapeutic Goods Administration. Australian Product Information – Tecvayli (teclistamab) solution for injection. Department of Health and Aged Care; 2024. [cited 2024 Oct 31]</u><span class="icon-icn-external-link"></span></a></li> <li id="r16"><a href="https://doi.org/10.1007/s12325-023-02480-7" class="link strong-pink small-weight no-border" target="_blank" tabindex="0"><u class="txt">Moreau P, van de Donk N, Delforge M, Einsele H, De Stefano V, Perrot A, et al. Comparative Efficacy of Teclistamab Versus Current Treatments in Real-World Clinical Practice in the Prospective LocoMMotion Study in Patients with Triple-Class-Exposed Relapsed and/or Refractory Multiple Myeloma. Adv Ther 2023;40:2412-25.</u><span class="icon-icn-external-link"></span></a></li> <li id="r17"><a href="https://doi.org/10.1097/01.HS9.0000936248.01150.e8" class="link strong-pink small-weight no-border" target="_blank" tabindex="0"><u class="txt">Searle E, Quach H, Wong S, Costa L, Hulin C, Janowski W, et al. P30 single cohort results from majestec-2: teclistamab (TEC) in combination with subcutaneous daratumumab (dara) and lenalidomide (LEN) in patients with multiple myeloma (MM). HemaSphere 2023;7:27.</u><span class="icon-icn-external-link"></span></a></li> <li id="r18"><a href="https://doi.org/10.1097/01.HS9.0000970364.16259.0e" class="link strong-pink small-weight no-border" target="_blank" tabindex="0"><u class="txt">Tan C, Searle E, Anguille S, Bhutani M, Biran N, Boyd K, et al. P865: teclistamab in combination with lenalidomide in previously treated patients with multiple myeloma in the phase 1B multicohort MajesTEC-2 study. HemaSphere 2023;7:e162590e.</u><span class="icon-icn-external-link"></span></a></li> <li id="r19"><a href="https://clinicaltrials.gov/study/NCT05572515" class="link strong-pink small-weight no-border" target="_blank" tabindex="0"><u class="txt">ClinicalTrials.gov. A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9). Identifier NCT05572515. National Library of Medicine (US); 2024. [cited 2024 Nov 1]</u><span class="icon-icn-external-link"></span></a></li> </ol> <span class="line large bg-strong-pink"> </span> <p><i>The new drug comments</i><i> in </i>Australian Prescriber<i> are prepared by the editors and reviewed by the </i><a href="https://australianprescriber.tg.org.au/about-us.html#editorial-advisory-committee" target="_self" title="https://australianprescriber.tg.org.au/about-us.html#editorial-advisory-committee"><i>Editorial Advisory Committee</i></a><i>. Some of the views expressed on newly approved products should be regarded as preliminary, as there may be limited published data at the time of publication, and little experience in Australia of their safety or efficacy. 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