A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. Using data from patients with relapsed/refractory MM (N=300) who participated in phase 1 studies of teclistamab (NCT03145181) or talquetamab (NCT03399799), baseline serum sBCMA levels were quantitatively analyzed relative to response to treatment, percentage of bone marrow plasma cells (BMPCs), and cytogenetic risk. [3] CD3 is involved in activating T-cells, and GPRC5D is highly expressed on multiple myeloma cells. [1] NCT04586426: Phase 1b - Talquetamab and Teclistamab in Relapsed or Refractory Multiple Myeloma. 10: Teclistamab in RRMM: Patient Selection and Combining Therapies. Depth of response correlated with the magnitude of sBCMA reduction. DOI: 10.1200/JCO.2021.39.15_suppl.8047 Journal of Clinical Oncology All content is developed independently by SES in collaboration with an expert steering committee; funders are allowed no direct influence on the content of the hub. This site needs JavaScript to work properly. Tel: 1-212-634-7914 Copyright 2022 American Society of Hematology. The study will evaluate the clinical hypothesis that talquetamab or teclistamab can be safely . The objective of this work was to evaluate sBCMA in relapsed and/or refractory MM patients in response to treatment with teclistamab or talquetamab. Print Subscriber? Permissions, Authors End of study is defined as last study assessment for last participant in study. About Teclistamab 2318 Mill Road, Suite 800, Alexandria, VA 22314, 2022 American Society of Clinical Oncology. Copyright 2022 SurvivorNet, Inc. All Rights Reserved. NCT04586426: Phase 1b - Talquetamab and Teclistamab in Relapsed or Refractory Multiple Myeloma. Teclistamab is a companion bispecific to Janssen's talquetamab, a bispecific antibody that binds to CD3 and GPRC5D, a novel myeloma target. CancerLinQ Soluble BCMA data were quantitatively analyzed in reference to patients tumor burden and response, as well as pharmacokinetic data. Talquetamab is a humanized IgG4PAA bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). Blood Cancers. JCO Oncology Practice Infections were frequent (in 76.4%; grade 3 or 4, 44.8%). Acute Myeloid Leukemia (AML) Chronic Lymphocytic Leukemia (CLL) Lymphoma. ), and Service dHmatologie et Thrapie Cellulaire, Hpital Bretonneau, Centre Hospitalier Rgional Universitaire, Tours (L.B.) 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 . DOI: 10.1056/NEJMoa2203478. Talquetamab was designed to target the GPRC5Da receptor, which is highly present on cancerous plasma cells. Meeting Abstracts, About (Funded by Janssen Research and Development; MajesTEC-1 ClinicalTrials.gov numbers, NCT03145181 and NCT04557098. The overall rationale of this study is that talquetamab or teclistamab in combination with a PD-1 inhibitor may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study will evaluate the clinical hypothesis that talquetamab or teclistamab can be safely administered at the selected dose when combined with a PD-1 inhibitor. The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose (s) of talquetamab combination regimens. Both talquetamab and teclistamab work by helping the immune system find and attack multiple myeloma cells. Conquer Cancer Foundation Baseline sBCMA levels correlated with the percentage of BMPC; patients with extramedullary plasmacytomas who had low levels of BMPC (10%) tended to have high baseline sBCMA levels (400 ng/mL . The bispecific antibodies teclistamab (BCMACD3) and talquetamab (G protein- Bethesda, MD 20894, Web Policies In cycle 3, majority of the responders had reduction in sBCMA [88% (50 out of 57) for teclistamab and 98% (49 out of 50) for talquetamab] compared to baseline. ClinicalTrials.gov Identifier: NCT04586426, Official Title: A Phase 1b Dose Escalation Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma, Click here to see details on ClinicalTrials.gov, A Study of the Combination of Talquetamab and Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma | Global Trial Finder (janssen.com), daratumumab and hyaluronidase-fihj: National Cancer Institute, daratumumab and hyaluronidase-fihj: MedlinePlus Drug Information. The median duration of progression-free survival was 11.3 months (95% CI, 8.8 to 17.1). Information and tools for librarians about site license offerings. FOIA 2020 Sep 22;4(18):4538-4549. doi: 10.1182/bloodadvances.2020002393. PMC [1] Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body's immune system to fight the cancer. EP. The most advanced way to teach, practice, and assess clinical reasoning skills. Dr. Usmani is supported by a career development award from the Leukemia and Lymphoma Society. Cookies. ), Hospital Clnic, August Pi i Sunyer Biomedical Research Institute, University of Barcelona, Barcelona (L.R. JCO Precision Oncology, ASCO Educational Book The content of this site is intended for health care professionals. Epub 2021 Jul 28. Concise summaries and expert physician commentary that busy clinicians need to enhance patient care. Talquetamab has also shown promise in myeloma in the . Prepare to become a physician, build your knowledge, lead a health care organization, and advance your career with NEJM Group information and services. Preclinical studies demonstrated that talquetamab works by triggering the death of GPRC5D-expressing cells by binding and activating T-cells. The utilization of -secretase inhibitor at low doses to increase BCMA . Baseline sBCMA levels and changes in sBCMA levels at cycle 3 day 1 were similar in patients with high- and standard-risk cytogenetics treated with teclistamab or talquetamab. With a median follow-up of 14.1 months, the overall response rate was 63.0%, with 65 patients (39.4%) having a complete response or better. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. Leukemia. Results from the study show heavily pretreated patients with multiple myeloma treated with the combination, including talquetamab at the recommended subcutaneous Phase 2 dose (RP2D) administered weekly (QW) or every two weeks (Q2W), achieved high rates of responses . EP. TNB-383B. My mother has been in a talquetamab trial about 2 months now and has also experienced loss of taste and also loss of smell, dry mouth, swallowing difficulty, peeling skin and swollen feet and lower legs. Soluble BCMA corelated with % bone marrow TPCs. NEW! PVX-410. Teclistamab resulted in a high rate of deep and durable response in patients with triple-classexposed relapsed or refractory multiple myeloma. In the phase 1 dose-defining portion of the study, teclistamab showed promising efficacy in patients with relapsed or refractory multiple myeloma. Study Design Go to Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Multiple myeloma On the contrary, non-responders (progressive disease, stable disease, or minimal response) seemed to show an increase in sBCMA [80% (33 out of 41) for teclistamab and 49% (24 out of 49) for talquetamab] from baseline. Learn more about Institutional Access. Teclistamab. Subscribe now. Majority of patients with plasmacytoma (limited data) seemed to have high sBCMA; suggesting sBCMA could be a comprehensive marker for tumor burden. Use this bar to access information about the steps in your cancer journey. In this phase 12 study, we enrolled patients who had relapsed or refractory myeloma after at least three therapy lines, including triple-class exposure to an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody. Inclusion Criteria: Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level >= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Exclusion Criteria: Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months) Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis Active Central Nervous System (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. . TECLISTAMAB AND TALQUETAMAB STUDIES: NCT04586426: Phase 1b - Talquetamab and Teclistamab in Relapsed or Refractory Multiple Myeloma Click here for details NCT04108195: Phase 1b - Subcutaneous Dara With Bispecific T Cell Redirection Antibodies - TRIMM-2 Click here for details Tags: Europe Teclistamab Lenalidomide Janssen EMN Australia Germany Italy Preclinical activity and determinants of response of the GPRC5DxCD3 bispecific antibody talquetamab in multiple myeloma. 8600 Rockville Pike The binding of daratumumab to natural killer (NK) cells mimics the normal CD38-CD31 interaction on the NK cell surface. Vaccines. government site. Enter words / phrases / DOI / ISBN / authors / keywords / etc. JCO Global Oncology Targeted protein degraders. (May 20, 2021) A fully human monoclonal antibody directed against the cell surface glycoprotein CD-38 with potential antineoplastic activity. An official website of the United States government. ), QUICK TAKE VIDEO SUMMARYTeclistamab in Multiple Myeloma02:05, Are you a member of an institution such as a university or hospital? Janssen R&D, Spring House, PA; Janssen R&D, Beerse, Belgium; Janssen R&D, Raritan, NJ, Professional English and Academic Editing Support, https://doi.org/10.1200/JCO.2021.39.15_suppl.8047. HHS Vulnerability Disclosure, Help The study will consist of a screening period, treatment period (Part 1: dose escalation and Part 2: dose expansion) and a post treatment follow-up. August 11, 2022N Engl J Med 2022; 387:495-505 Use tab to navigate through the menu items. SurvivorNets Guide to Clinical Trials: What Are They and Are They Right for You? The https:// ensures that you are connecting to the JCO Clinical Cancer Informatics Among those, 30 received a dose of (405 g/kg QW), and within that group, 70% (21/30) achieved a response, 53% achieved a very good partial response or better, 13% achieved a complete response (CR) or better, and 10 . A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma (TRIMM-3) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Thank you for sharing this information. Lets see if you might be eligible for this study. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required Live, attenuated vaccine within 4 weeks before the first dose of study treatment Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia [any grade] or peripheral neuropathy to Grade <= 2) Received a cumulative dose of corticosteroids equivalent to >= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration. CFT7455. NCI CPTC Antibody Characterization Program. Dr. Usmani can be contacted at [emailprotected] or at the Memorial Sloan Kettering Cancer Center, 1275 York Ave., New York, NY 10065. Cancer.Net, ASCO.org Talquetamab. Methods: Serum samples from relapsed and/or refractory MM patients in teclistamab and talquetamab phase 1 studies (64007957MMY1001 and 64407564MMY1001) were collected (at various timepoints between baseline and cycle 4 or end of treatment) and analyzed for sBCMA by an electrochemiluminescence ligand binding assay. This was for talquetamab, which again targets this specific anchor. Rationale for combining talquetamab and teclistamab is that, these agents promote the activation of T cells and induce myeloma cell lysis mediated by secreted perforin and various granzymes stored in the secretory vesicles of cytotoxic T cells and daratumumab induces lysis of CD38-expressing tumor cells by a number of mechanisms, including . all in France; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.L.G. Or teclistamab can be safely, Hpital Bretonneau, Centre Hospitalier Rgional Universitaire, Tours (.... 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