{"entity":{"id":"talquetamab","kind":"drug","name":"Talquetamab","aka":[],"tldr":"Talquetamab is the first drug against GPRC5D, a second myeloma target used after BCMA therapies stop working; taste and skin side effects are its signature.","summary":"Talquetamab is a humanised IgG4 GPRC5DxCD3 bispecific antibody and the first drug against GPRC5D, a receptor expressed on plasma cells and on keratinised tissue. In MonumenTAL-1 the ORR was about 73% at both the weekly and biweekly doses, including about 65% in patients after prior T-cell redirection, showing that a second target works after BCMA therapy stops. Accelerated approval followed in August 2023 after at least 4 prior lines. Dysgeusia (72%), skin toxicity (67%) and nail disorders (54%) are frequent, cytokine release syndrome was grade 3 or higher in only 2%, and infection rates are lower than with BCMA agents. Combinations with teclistamab (RedirecTT-1, ORR about 80% with extramedullary disease) and daratumumab (TRIMM-2) are in phase 3 (MonumenTAL-3, -5 and -6). It opened a second target after BCMA in myeloma, at the cost of taste and skin effects.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Talquetamab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Talquetamab"}],"tags":[],"related":[],"cancers":["multiple-myeloma","myeloma-relapsed-refractory"],"sections":[],"technologies":["t-cell-engager"],"targets":["gprc5d","cd3"],"drugs":[],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":[],"trials":["monumental-1","nct06208150","nct05552222","nct05455320","nct06550895","nct04586426","nct06577025","nct06500884"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Talvey","modality":"Bispecific T-cell engager (GPRC5D×CD3)","mechanism":"Humanised IgG4 GPRC5D×CD3 bispecific; GPRC5D is expressed on plasma cells and keratinised tissue.","approvals":[{"region":"US","year":2023,"indication":"Relapsed/refractory myeloma after ≥4 lines (accelerated)"}],"mechanismSteps":[],"dosing":{"route":"Subcutaneous","schedule":"Step-up then 0.4 mg/kg weekly or 0.8 mg/kg every 2 weeks","monitoring":"CRS, dysgeusia and weight loss, skin/nail toxicity, infections (lower than BCMA agents)"},"toxicity":[{"event":"Dysgeusia","anyGradePct":72,"note":"MonumenTAL-1"},{"event":"Skin toxicity","anyGradePct":67},{"event":"Nail disorders","anyGradePct":54},{"event":"Cytokine release syndrome","anyGradePct":77,"grade3PlusPct":2}],"access":[],"regulatoryEvents":[{"date":"2023-08-09","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 3.1 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-talquetamab-tgvs-relapsed-or-refractory-multiple-myeloma","indication":"Adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody"}]},"route":"/drugs/talquetamab/","neighbours":{"cancer":[{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"},{"id":"plasma-cell-leukaemia","kind":"cancer","name":"Plasma cell leukaemia","route":"/cancers/plasma-cell-leukaemia/"},{"id":"myeloma-relapsed-refractory","kind":"cancer","name":"Relapsed or refractory multiple myeloma","route":"/cancers/myeloma-relapsed-refractory/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"cd3","kind":"target","name":"CD3","route":"/targets/cd3/"},{"id":"gprc5d","kind":"target","name":"GPRC5D","route":"/targets/gprc5d/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"trial":[{"id":"nct05455320","kind":"trial","name":"A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination Wi","route":"/trials/nct05455320/"},{"id":"nct06208150","kind":"trial","name":"A Study Comparing Talquetamab Plus Pomalidomide, Talquetamab Plus Teclistamab, and Elotuzumab, Pomalidomide, and Dexamethasone or Pomalidomide, Bortez","route":"/trials/nct06208150/"},{"id":"nct06550895","kind":"trial","name":"A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma","route":"/trials/nct06550895/"},{"id":"nct06577025","kind":"trial","name":"A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Ind","route":"/trials/nct06577025/"},{"id":"nct05552222","kind":"trial","name":"A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal","route":"/trials/nct05552222/"},{"id":"nct04586426","kind":"trial","name":"A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma","route":"/trials/nct04586426/"},{"id":"nct06500884","kind":"trial","name":"A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events","route":"/trials/nct06500884/"},{"id":"monumental-1","kind":"trial","name":"MonumenTAL-1","route":"/trials/monumental-1/"}],"pairing":[{"id":"bcma-then-gprc5d","kind":"pairing","name":"BCMA-directed therapy → GPRC5D-directed therapy","route":"/pairings/bcma-then-gprc5d/"}],"paper":[{"id":"paper-magnetismm-3-elranatamab-natmed-2023","kind":"paper","name":"MagnetisMM-3: elranatamab, a second BCMA bispecific, with a switch to fortnightly dosing after response","route":"/key-papers/paper-magnetismm-3-elranatamab-natmed-2023/"},{"id":"paper-majestec-1-teclistamab-nejm-2022","kind":"paper","name":"MajesTEC-1: teclistamab, an off-the-shelf BCMA bispecific antibody, in heavily pretreated myeloma","route":"/key-papers/paper-majestec-1-teclistamab-nejm-2022/"},{"id":"paper-monumental-1-talquetamab-nejm-2022","kind":"paper","name":"MonumenTAL-1: talquetamab, a GPRC5D-directed bispecific antibody for relapsed multiple myeloma","route":"/key-papers/paper-monumental-1-talquetamab-nejm-2022/"}],"drug":[{"id":"isb-2001","kind":"drug","name":"ISB 2001","route":"/drugs/isb-2001/"}],"biomarker":[{"id":"gprc5d-expression","kind":"biomarker","name":"GPRC5D expression","route":"/biomarkers/gprc5d-expression/"}]}}