Lancet Haematology最新文献

{"title":"CAR T-cell therapy in LMICs: approval of talicabtagene autoleucel in India.","authors":"Luca Paruzzo, Marco Ruella","doi":"10.1016/S2352-3026(25)00040-7","DOIUrl":"10.1016/S2352-3026(25)00040-7","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":" ","pages":"e236-e238"},"PeriodicalIF":15.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study.","authors":"Ajai Chari, Cyrille Touzeau, Carolina Schinke, Monique C Minnema, Jesus G Berdeja, Albert Oriol, Niels W C J van de Donk, Paula Rodríguez-Otero, Daniel Morillo, Carmen Martinez-Chamorro, María-Victoria Mateos, Luciano J Costa, Jo Caers, Leo Rasche, Amrita Krishnan, Jing Christine Ye, Lionel Karlin, Brea Lipe, Deeksha Vishwamitra, Sheri Skerget, Raluca Verona, Xuewen Ma, Xiang Qin, Hein Ludlage, Michela Campagna, Tara Masterson, Brandi Hilder, Jaszianne Tolbert, Thomas Renaud, Jenna D Goldberg, Colleen Kane, Christoph Heuck, Jesus San-Miguel, Philippe Moreau","doi":"10.1016/S2352-3026(24)00385-5","DOIUrl":"10.1016/S2352-3026(24)00385-5","url":null,"abstract":"<p><strong>Background: </strong>Talquetamab is the first GPRC5D × CD3 bispecific antibody approved for relapsed or refractory multiple myeloma. In phase 1 of the MonumenTAL-1 study, initial results of subcutaneous talquetamab 0·4 mg/kg once a week and 0·8 mg/kg every 2 weeks showed preliminary clinical activity. We describe safety and activity results in patients treated with talquetamab, including patients who had received previous T-cell redirection therapy (TCR). This post-hoc analysis was done with more mature median follow-up to evaluate duration of response in patients treated with talquetamab 0·8 mg/kg every 2 weeks.</p><p><strong>Methods: </strong>MonumenTAL-1 is a multicentre, open-label, phase 1-2 study of talquetamab, phase 1 of which has previously been published. The 0·4 mg/kg once a week and 0·8 mg/kg every 2 weeks recommended subcutaneous doses identified in phase 1 were evaluated in phase 2 in patients who were 18 years of age or older, had at least three previous lines of therapy, had an Eastern Cooperative Oncology Group performance status of 0 to 2, and were naive or exposed to previous TCR. The primary endpoint was overall response rate assessed by independent review committee in all patients who received at least one dose of talquetamab. Safety was assessed in all patients who received at least one dose of talquetamab. This study was registered with ClinicalTrials.gov, NCT03399799 (phase 1) and NCT04634552 (phase 2).</p><p><strong>Findings: </strong>Between Jan 3, 2018, and Feb 20, 2023, 735 patients were screened across all phase 1-2 cohorts. Of these, 537 patients screened for inclusion were treated across phase 1 and 2 cohorts, of whom 198 (27%) patients were excluded from the study, most commonly due to not meeting eligibility criteria or not having measurable disease. As of Oct 11, 2023, 375 patients had received recommended talquetamab doses across three groups: 143 (0·4 mg/kg once a week group) and 154 (0·8 mg/kg every 2 weeks group) TCR-naive patients and 78 with previous TCR who received either recommended dose (previous TCR group). 217 (58%) of 375 patients were male and 158 (42%) were female. 325 (87%) of 375 patients were White and 32 (9%) patients were Black. Median follow-up was 25·6 months (IQR 8·5-25·9) in the 0·4 mg/kg once a week group, 19·4 months (9·2-20·7) in the 0·8 mg/kg every 2 weeks group, and 16·8 months (7·6-18·7) in the previous TCR group. Overall response rate was 74% (106 of 143 patients, 95% CI 66-81) in the 0·4 mg/kg once a week group, 69% (107 of 154 patients, 62-77) in the 0·8 mg/kg every 2 weeks group, and 67% (52 of 78 patients, 55-77) in the previous TCR group. Most common adverse events in the 0·4 mg/kg once a week, 0·8 mg/kg every 2 weeks, and previous TCR groups were cytokine release syndrome (113 [79%] of 143 patients, 115 [75%] of 154 patients, and 57 [73%] of 78 patients), taste changes (103 [72%], 110 [71%], and 59 [76%]), and infections (85 [59%], 105 [68%], and 59 [76%]). Most com","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":" ","pages":"e269-e281"},"PeriodicalIF":15.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction to Lancet Haematol 2025; 12: e128-37.","authors":"","doi":"10.1016/S2352-3026(25)00076-6","DOIUrl":"https://doi.org/10.1016/S2352-3026(25)00076-6","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 4","pages":"e243"},"PeriodicalIF":15.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CAR T-cell therapy: navigating real-world challenges beyond clinical trials.","authors":"The Lancet Haematology","doi":"10.1016/S2352-3026(25)00079-1","DOIUrl":"https://doi.org/10.1016/S2352-3026(25)00079-1","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 4","pages":"e231"},"PeriodicalIF":15.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Now where do we STAND with crizanlizumab?","authors":"Sebastian Mendez-Marti, Swee Lay Thein","doi":"10.1016/S2352-3026(25)00033-X","DOIUrl":"10.1016/S2352-3026(25)00033-X","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":" ","pages":"e232-e233"},"PeriodicalIF":15.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143634886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fedratinib for patients with myelofibrosis.","authors":"Ruben Van Dijck, John-John Schnog, Peter Te Boekhorst","doi":"10.1016/S2352-3026(24)00398-3","DOIUrl":"https://doi.org/10.1016/S2352-3026(24)00398-3","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 4","pages":"e240"},"PeriodicalIF":15.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Monumen-TAL progress in the treatment of relapsed multiple myeloma.","authors":"Susan Bal","doi":"10.1016/S2352-3026(25)00009-2","DOIUrl":"10.1016/S2352-3026(25)00009-2","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":" ","pages":"e235-e236"},"PeriodicalIF":15.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction to Lancet Haematol 2025; 12: e120-27.","authors":"","doi":"10.1016/S2352-3026(25)00072-9","DOIUrl":"https://doi.org/10.1016/S2352-3026(25)00072-9","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 4","pages":"e243"},"PeriodicalIF":15.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality-of-life endpoints collection, reporting, and framing in randomised trials of indolent lymphomas: a systematic review.","authors":"Charles J Milrod, Lila Rubin, Boris Martinez, Thomas A Ollila, Adam J Olszewski, Ari Pelcovits","doi":"10.1016/S2352-3026(25)00032-8","DOIUrl":"10.1016/S2352-3026(25)00032-8","url":null,"abstract":"<p><p>Indolent lymphomas are generally incurable, with protracted disease courses. The approval of drug treatment options often relies on surrogate endpoints (eg, progression-free survival), which do not capture patient-centred outcomes such as quality of life (QOL). This systematic review characterises the use of QOL as an endpoint in randomised controlled trials (RCTs) of indolent lymphomas, and the association of QOL with survival outcomes. ClinicalTrials.gov was searched from database inception to May 20, 2024, for phase 3 RCTs of indolent lymphomas, including follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia or small lymphocytic lymphoma, gastric mucosa-associated lymphoid tissue lymphoma, and Waldenström macroglobulinaemia. 103 RCTs met eligibility criteria. Data on QOL endpoints were collected in 53 (51%) of 103 trials, but reported in only 25 (24%). Improvements in QOL was reported in 11 (44%) of these RCTs, and these trials were more likely to show progression-free survival and overall survival benefits. We found that trials with neutral or worsened QOL outcomes often framed the results positively, presenting QOL data as supporting treatment use. This systematic review highlights that data on QOL endpoints are undercollected, under-reported, and often positively framed despite a lack of improvement, underscoring the need for transparent QOL reporting to enhance patient-centred care.</p>","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 4","pages":"e312-e317"},"PeriodicalIF":15.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fedratinib for patients with myelofibrosis - Authors' reply.","authors":"Claire N Harrison, Patrick Brown, Jean-Jacques Kiladjian","doi":"10.1016/S2352-3026(25)00010-9","DOIUrl":"https://doi.org/10.1016/S2352-3026(25)00010-9","url":null,"abstract":"","PeriodicalId":48726,"journal":{"name":"Lancet Haematology","volume":"12 4","pages":"e241-e242"},"PeriodicalIF":15.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}