The impact of reduced dosing frequency of elranatamab on patient-reported outcomes in patients with relapsed or refractory multiple myeloma: Results from MagnetisMM-3

IF 14.6 2区 医学 Q1 HEMATOLOGY
HemaSphere Pub Date : 2025-09-23 DOI:10.1002/hem3.70224
Nizar J. Bahlis, Ajay K. Nooka, Marco DiBonaventura, Sharon T. Sullivan, Mohammad A. Chaudhary, Didem Aydin, Mohamad Mohty
{"title":"The impact of reduced dosing frequency of elranatamab on patient-reported outcomes in patients with relapsed or refractory multiple myeloma: Results from MagnetisMM-3","authors":"Nizar J. Bahlis,&nbsp;Ajay K. Nooka,&nbsp;Marco DiBonaventura,&nbsp;Sharon T. Sullivan,&nbsp;Mohammad A. Chaudhary,&nbsp;Didem Aydin,&nbsp;Mohamad Mohty","doi":"10.1002/hem3.70224","DOIUrl":null,"url":null,"abstract":"<p>Multiple myeloma (MM) is associated with a range of clinical symptoms, including bone pain, anemia, renal dysfunction, and hypercalcemia.<span><sup>1, 2</sup></span> Given the chronic nature of MM, its symptom burden, and the side effects of its treatments, monitoring health-related quality of life (HRQOL) via patient-reported outcomes (PROs) has emerged as a critical aspect of patient care.<span><sup>3-5</sup></span></p><p>Elranatamab, a humanized bispecific antibody that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells, has demonstrated efficacy and safety in patients with relapsed or refractory MM (RRMM) in the registrational Phase 2 MagnetisMM-3 clinical trial (NCT04649359).<span><sup>6-8</sup></span> Patients in the MagnetisMM-3 study reported improvements in PROs, regardless of prior exposure to BCMA-directed therapy, with notable reductions in pain and disease symptoms, and improvements in patients' outlook on their future health.<span><sup>9</sup></span></p><p>Reduction in the dosing frequency of bispecific antibodies offers convenience and flexibility to patients.<span><sup>10</sup></span> In the MagnetisMM-3 study, patients who received weekly (QW) elranatamab for ≥6 cycles and achieved a partial response (PR) or better persisting for ≥2 months were eligible to transition to an every 2-week (Q2W) dosing schedule.<span><sup>7-9</sup></span> While prior analyses have examined the impact of a Q2W dosing schedule on clinical outcomes,<span><sup>7</sup></span> here we report the effect of switching from QW to Q2W elranatamab dosing on PROs among both BCMA-naive and -exposed patients from the MagnetisMM-3 study, hypothesizing that HRQOL would, at a minimum, be maintained as the incidence of TEAEs decreased after a reduction in dosing frequency while most patients maintained their response to elranatamab.</p><p>MagnetisMM-3 (NCT04649359) is an open-label, multicenter, nonrandomized, Phase 2 registrational study evaluating the efficacy and safety of elranatamab monotherapy in patients with RRMM.<span><sup>7, 8</sup></span> Eligibility criteria have been previously described.<span><sup>7-9</sup></span> Two patient cohorts were enrolled, those without (BCMA naive) or with (BCMA exposed) prior exposure to a BCMA-directed antibody–drug conjugate and/or chimeric antigen receptor T-cell therapy. The study was conducted in accordance with the International Council for Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. The study protocol was approved by local or independent institutional review boards or ethics committees at participating sites. All patients provided written informed consent.</p><p>Patient-reported outcomes (PROs) were a prespecified exploratory endpoint of the MagnetisMM-3 study.<span><sup>9</sup></span> All PRO measures were administered electronically on D1 and D15 of the first three cycles and D1 of each subsequent cycle through Cycle 12. Thereafter, PRO assessments were administered every three cycles. Additional information can be found in the Supporting Information. The data cutoff for this analysis was March 26, 2024, which represented a median follow-up of approximately 28 months for the overall study population.</p><p>The analysis dataset included all patients who switched from QW to Q2W dosing intervals. The point at which patients switched from QW to Q2W administration was classified as their baseline (“Q2W baseline”).</p><p>Of the 61 BCMA-naive patients and 22 BCMA-exposed patients who were treated with elranatamab through at least Cycle 7 in the MagnetisMM-3 study, a total of 58 and 19 patients, respectively, transitioned from QW to Q2W dosing (93%). This analysis focused exclusively on these patients. Demographic and clinical characteristics were generally similar between the two cohorts (Table S1). BCMA-naive and -exposed patients had a median age of 67.5 and 67.0 years, respectively. Differences between the BCMA-naive and -exposed cohorts, respectively, included the median number of prior lines of therapy (5.0 and 7.0) as well as the incidence of an Eastern Cooperative Oncology Group performance status of 2 (5.2% and 10.5%), Revised International Staging System disease Stage III (6.9% and 15.8%), and high-risk cytogenetics (22.4% and 15.8%).</p><p>Overall QOL was assessed by the EQ-5D-5L questionnaire index score (Figure 1A,B). Scores for BCMA-naive patients remained at or near Q2W baseline levels through Month 18. A numerically greater worsening from the Q2W baseline for BCMA-exposed patients was observed at Month 18; however, again, this was based only on very small patient numbers.</p><p>Global health status scores for both BCMA-naive and -exposed patients were generally stable over time compared with those reported at Q2W baseline (Figure 1C,D). In BCMA-naive patients, scores were maintained through Month 13 with a nonsignificant (95% CI overlaps with Q2W baseline) improvement at Month 16 and a nonsignificant worsening in the PRO score at Month 18. In BCMA-exposed patients, scores generally improved after Month 6, with a numerically larger improvement by Month 18 (in both cohorts, the observed scores at Month 18 may be due to small sample sizes).</p><p>Similarly, QLQ-C30 scores for fatigue for both cohorts generally remained at or near Q2W baseline levels through Month 16, with nonsignificant worsening at Month 18 (Figure 1E,F).</p><p>Pain scores in BCMA-naive patients remained near Q2W baseline levels through Month 7, with numerically larger worsening at Months 10, 16, and 18 (Figure 1G). However, smaller sample sizes for Month 18 may limit the interpretability of the data. Pain scores for BCMA-exposed patients showed a transient improvement relative to Q2W baseline at Month 6, then returned to and were maintained near Q2W baseline from Month 7 through Month 18 (Figure 1H).</p><p>Results from the MM-specific QLQ-MY20 questionnaire revealed that scores for disease symptoms in both cohorts remained at or near Q2W baseline levels through Month 16 (Figure 2A,B). At Month 18, a numerically larger improvement was observed for BCMA-naive patients and a numerically larger worsening was observed for BCMA-exposed patients; however, small patient numbers for PROs in Month 18 may limit the interpretability of these data.</p><p>QLQ-MY20 scores in the side effects domain indicated little change from Q2W baseline levels through Month 16 for BCMA-naive patients. A worsening at Month 18 may be due to the small sample size (Figure 2C). A numerically greater improvement from Q2W baseline in side effect domain scores for BCMA-exposed patients was observed at Month 7; however, domain scores stabilized near Q2W baseline levels by Month 10, improved by Month 16, and were maintained through Month 18 (Figure 2D).</p><p>For BCMA-naive patients, scores for body image remained at or near Q2W baseline levels through Month 18 (Figure 2E). Numerically greater improvements in the PRO score for BCMA-exposed patients were observed at Months 10, 13, and 16 (Figure 2F). A nonsignificant worsening in the PRO score was observed at Month 18, but the sample size was quite small. Similarly, scores for future perspectives were largely consistent with Q2W baseline values through Month 18 for both cohorts (Figure 2G,H).</p><p>This analysis of PROs from BCMA-naive and -exposed patients with RRMM from the MagnetisMM-3 study who transitioned to Q2W elranatamab dosing demonstrated that HRQOL was largely maintained over 18 months after this switch, including measures of fatigue, pain, disease symptoms, and overall QOL, regardless of prior exposure to BCMA-directed therapy. Numerically larger deteriorations or improvements were seen around Month 18 for some domain scores; however, small sample sizes (≤6) make any interpretation difficult. The minimal impact of the switch to less frequent dosing on patient-reported QOL and disease symptoms likely reflects the maintenance of disease control and an improved safety profile.<span><sup>7</sup></span></p><p>Patients who switched to less frequent dosing of elranatamab did not experience a worsening in reported pain, fatigue, or disease symptoms and had largely stable side effect, QOL, body image, and future perspective domain scores.</p><p>An extended dosing interval for elranatamab limits the number of contact days with a healthcare system and reduces time spent by patients coordinating treatments and visits to a healthcare facility.<span><sup>10</sup></span> Reducing the number of contact days without compromising the efficacy or safety of bispecific antibody therapy may significantly impact a patient's QOL and influence their treatment choice. Taken together with other PROs, these findings underscore the potential benefit of tailoring dosing schedules to enhance patient satisfaction without compromising therapeutic outcomes or safety.</p><p>One limitation of this analysis was self-selection population bias. In the MagnetisMM-3 study, patients were not randomized to receive elranatamab Q2W; only patients who met the dose switching criteria were eligible to transition from QW to Q2W dosing. Second, follow-up time in this analysis was variable, as it was a function of when the patient met the eligibility criteria and was transitioned to Q2W treatment. Not all patients had the opportunity to have a long follow-up period after switching to Q2W treatment, resulting in lower patient population numbers at later time points. Thus, results at later time points should be interpreted with caution.</p><p>In conclusion, despite occasional transient changes in some PRO measures, the switch in elranatamab dosing schedules from QW to Q2W was not detrimental to patient QOL as assessed by measures of patient-reported functioning and symptoms. Most domain scores remained stable for well over 1 year. These data complement the findings that clinical benefit and safety are not negatively affected by a Q2W elranatamab dosing frequency<span><sup>10</sup></span> and further support elranatamab for the treatment of patients with RRMM, regardless of prior BCMA-targeted therapy.</p><p><b>Nizar J. Bahlis</b>: Conceptualization; methodology; data curation; investigation; validation; formal analysis; writing—original draft; writing—review and editing. <b>Ajay K. Nooka</b>: Conceptualization; methodology; data curation; formal analysis; validation; investigation; writing—original draft; writing—review and editing. <b>Marco DiBonaventura</b>: Conceptualization; writing—original draft; writing—review and editing; methodology; data curation; formal analysis; validation; investigation. <b>Sharon T. Sullivan</b>: Conceptualization; methodology; data curation; formal analysis; validation; investigation; writing—original draft; writing—review and editing. <b>Mohammad A. Chaudhary</b>: Methodology; conceptualization; data curation; formal analysis; validation; writing—original draft; writing—review and editing. <b>Didem Aydin</b>: Conceptualization; methodology; data curation; formal analysis; writing—review and editing; writing—original draft; validation. <b>Mohamad Mohty</b>: Conceptualization; methodology; data curation; formal analysis; validation; writing—review and editing; writing—original draft.</p><p>Information on the MagnetisMM-3 study (NCT04649359) can be found at ClincialTrials.gov.</p><p>Nizar J. Bahlis reports honoraria from AbbVie, Amgen, Celgene, Genentech/Roche, GSK, Janssen, Karyopharm Therapeutics, Sanofi, and Takeda; consulting or advisory roles for Amgen, Celgene, Janssen, Karyopharm Therapeutics, Pfizer, Sanofi, and Takeda; and patents, royalties, or other intellectual property from Celgene and Janssen. Ajay K. Nooka reports honoraria from Adaptive Biotechnologies, Amgen, BeyondSpring Pharmaceuticals, Bristol-Myers Squibb/Celgene, Cellectar, Genzyme, GSK, Janssen Oncology, Karyopharm Therapeutics, Oncopeptides, ONK Therapeutics, Pfizer, Secura Bio, and Takeda; consulting or advisory roles for Adaptive Biotechnologies, Amgen, BeyondSpring Pharmaceuticals, Bristol-Myers Squibb, Cellectar, Genzyme, GSK, Janssen Oncology, Karyopharm Therapeutics, Oncopeptides, ONK Therapeutics, Pfizer, Secura Bio, and Takeda; research funding from Amgen, Arch Oncology, Bristol-Myers Squibb/Celgene, Cellectar, GSK, Janssen Oncology, Pfizer, and Takeda; and travel, accommodations, and expenses from GSK. Marco DiBonaventura, Sharon T. Sullivan, and Didem Aydin report employment and stock ownership with Pfizer. Mohammad A. Chaudhary reports employment with Pfizer. Mohamad Mohty reports honoraria from Amgen and Celgene; consulting or advisory roles for Adaptive Biotechnologies, GSK, Jazz Pharmaceuticals, MaaT Pharma, Novartis, Sanofi, and Xenikos; and speakers bureaus roles for Janssen, Jazz Pharmaceuticals, and Sanofi.</p><p>This study was conducted in accordance with the International Council for Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. The study protocol was approved by local or independent institutional review boards or ethics committees at participating sites.</p><p>This study was funded by Pfizer.</p><p>All the patients provided written informed consent.</p>","PeriodicalId":12982,"journal":{"name":"HemaSphere","volume":"9 9","pages":""},"PeriodicalIF":14.6000,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12455012/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"HemaSphere","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/hem3.70224","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Multiple myeloma (MM) is associated with a range of clinical symptoms, including bone pain, anemia, renal dysfunction, and hypercalcemia.1, 2 Given the chronic nature of MM, its symptom burden, and the side effects of its treatments, monitoring health-related quality of life (HRQOL) via patient-reported outcomes (PROs) has emerged as a critical aspect of patient care.3-5

Elranatamab, a humanized bispecific antibody that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells, has demonstrated efficacy and safety in patients with relapsed or refractory MM (RRMM) in the registrational Phase 2 MagnetisMM-3 clinical trial (NCT04649359).6-8 Patients in the MagnetisMM-3 study reported improvements in PROs, regardless of prior exposure to BCMA-directed therapy, with notable reductions in pain and disease symptoms, and improvements in patients' outlook on their future health.9

Reduction in the dosing frequency of bispecific antibodies offers convenience and flexibility to patients.10 In the MagnetisMM-3 study, patients who received weekly (QW) elranatamab for ≥6 cycles and achieved a partial response (PR) or better persisting for ≥2 months were eligible to transition to an every 2-week (Q2W) dosing schedule.7-9 While prior analyses have examined the impact of a Q2W dosing schedule on clinical outcomes,7 here we report the effect of switching from QW to Q2W elranatamab dosing on PROs among both BCMA-naive and -exposed patients from the MagnetisMM-3 study, hypothesizing that HRQOL would, at a minimum, be maintained as the incidence of TEAEs decreased after a reduction in dosing frequency while most patients maintained their response to elranatamab.

MagnetisMM-3 (NCT04649359) is an open-label, multicenter, nonrandomized, Phase 2 registrational study evaluating the efficacy and safety of elranatamab monotherapy in patients with RRMM.7, 8 Eligibility criteria have been previously described.7-9 Two patient cohorts were enrolled, those without (BCMA naive) or with (BCMA exposed) prior exposure to a BCMA-directed antibody–drug conjugate and/or chimeric antigen receptor T-cell therapy. The study was conducted in accordance with the International Council for Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. The study protocol was approved by local or independent institutional review boards or ethics committees at participating sites. All patients provided written informed consent.

Patient-reported outcomes (PROs) were a prespecified exploratory endpoint of the MagnetisMM-3 study.9 All PRO measures were administered electronically on D1 and D15 of the first three cycles and D1 of each subsequent cycle through Cycle 12. Thereafter, PRO assessments were administered every three cycles. Additional information can be found in the Supporting Information. The data cutoff for this analysis was March 26, 2024, which represented a median follow-up of approximately 28 months for the overall study population.

The analysis dataset included all patients who switched from QW to Q2W dosing intervals. The point at which patients switched from QW to Q2W administration was classified as their baseline (“Q2W baseline”).

Of the 61 BCMA-naive patients and 22 BCMA-exposed patients who were treated with elranatamab through at least Cycle 7 in the MagnetisMM-3 study, a total of 58 and 19 patients, respectively, transitioned from QW to Q2W dosing (93%). This analysis focused exclusively on these patients. Demographic and clinical characteristics were generally similar between the two cohorts (Table S1). BCMA-naive and -exposed patients had a median age of 67.5 and 67.0 years, respectively. Differences between the BCMA-naive and -exposed cohorts, respectively, included the median number of prior lines of therapy (5.0 and 7.0) as well as the incidence of an Eastern Cooperative Oncology Group performance status of 2 (5.2% and 10.5%), Revised International Staging System disease Stage III (6.9% and 15.8%), and high-risk cytogenetics (22.4% and 15.8%).

Overall QOL was assessed by the EQ-5D-5L questionnaire index score (Figure 1A,B). Scores for BCMA-naive patients remained at or near Q2W baseline levels through Month 18. A numerically greater worsening from the Q2W baseline for BCMA-exposed patients was observed at Month 18; however, again, this was based only on very small patient numbers.

Global health status scores for both BCMA-naive and -exposed patients were generally stable over time compared with those reported at Q2W baseline (Figure 1C,D). In BCMA-naive patients, scores were maintained through Month 13 with a nonsignificant (95% CI overlaps with Q2W baseline) improvement at Month 16 and a nonsignificant worsening in the PRO score at Month 18. In BCMA-exposed patients, scores generally improved after Month 6, with a numerically larger improvement by Month 18 (in both cohorts, the observed scores at Month 18 may be due to small sample sizes).

Similarly, QLQ-C30 scores for fatigue for both cohorts generally remained at or near Q2W baseline levels through Month 16, with nonsignificant worsening at Month 18 (Figure 1E,F).

Pain scores in BCMA-naive patients remained near Q2W baseline levels through Month 7, with numerically larger worsening at Months 10, 16, and 18 (Figure 1G). However, smaller sample sizes for Month 18 may limit the interpretability of the data. Pain scores for BCMA-exposed patients showed a transient improvement relative to Q2W baseline at Month 6, then returned to and were maintained near Q2W baseline from Month 7 through Month 18 (Figure 1H).

Results from the MM-specific QLQ-MY20 questionnaire revealed that scores for disease symptoms in both cohorts remained at or near Q2W baseline levels through Month 16 (Figure 2A,B). At Month 18, a numerically larger improvement was observed for BCMA-naive patients and a numerically larger worsening was observed for BCMA-exposed patients; however, small patient numbers for PROs in Month 18 may limit the interpretability of these data.

QLQ-MY20 scores in the side effects domain indicated little change from Q2W baseline levels through Month 16 for BCMA-naive patients. A worsening at Month 18 may be due to the small sample size (Figure 2C). A numerically greater improvement from Q2W baseline in side effect domain scores for BCMA-exposed patients was observed at Month 7; however, domain scores stabilized near Q2W baseline levels by Month 10, improved by Month 16, and were maintained through Month 18 (Figure 2D).

For BCMA-naive patients, scores for body image remained at or near Q2W baseline levels through Month 18 (Figure 2E). Numerically greater improvements in the PRO score for BCMA-exposed patients were observed at Months 10, 13, and 16 (Figure 2F). A nonsignificant worsening in the PRO score was observed at Month 18, but the sample size was quite small. Similarly, scores for future perspectives were largely consistent with Q2W baseline values through Month 18 for both cohorts (Figure 2G,H).

This analysis of PROs from BCMA-naive and -exposed patients with RRMM from the MagnetisMM-3 study who transitioned to Q2W elranatamab dosing demonstrated that HRQOL was largely maintained over 18 months after this switch, including measures of fatigue, pain, disease symptoms, and overall QOL, regardless of prior exposure to BCMA-directed therapy. Numerically larger deteriorations or improvements were seen around Month 18 for some domain scores; however, small sample sizes (≤6) make any interpretation difficult. The minimal impact of the switch to less frequent dosing on patient-reported QOL and disease symptoms likely reflects the maintenance of disease control and an improved safety profile.7

Patients who switched to less frequent dosing of elranatamab did not experience a worsening in reported pain, fatigue, or disease symptoms and had largely stable side effect, QOL, body image, and future perspective domain scores.

An extended dosing interval for elranatamab limits the number of contact days with a healthcare system and reduces time spent by patients coordinating treatments and visits to a healthcare facility.10 Reducing the number of contact days without compromising the efficacy or safety of bispecific antibody therapy may significantly impact a patient's QOL and influence their treatment choice. Taken together with other PROs, these findings underscore the potential benefit of tailoring dosing schedules to enhance patient satisfaction without compromising therapeutic outcomes or safety.

One limitation of this analysis was self-selection population bias. In the MagnetisMM-3 study, patients were not randomized to receive elranatamab Q2W; only patients who met the dose switching criteria were eligible to transition from QW to Q2W dosing. Second, follow-up time in this analysis was variable, as it was a function of when the patient met the eligibility criteria and was transitioned to Q2W treatment. Not all patients had the opportunity to have a long follow-up period after switching to Q2W treatment, resulting in lower patient population numbers at later time points. Thus, results at later time points should be interpreted with caution.

In conclusion, despite occasional transient changes in some PRO measures, the switch in elranatamab dosing schedules from QW to Q2W was not detrimental to patient QOL as assessed by measures of patient-reported functioning and symptoms. Most domain scores remained stable for well over 1 year. These data complement the findings that clinical benefit and safety are not negatively affected by a Q2W elranatamab dosing frequency10 and further support elranatamab for the treatment of patients with RRMM, regardless of prior BCMA-targeted therapy.

Nizar J. Bahlis: Conceptualization; methodology; data curation; investigation; validation; formal analysis; writing—original draft; writing—review and editing. Ajay K. Nooka: Conceptualization; methodology; data curation; formal analysis; validation; investigation; writing—original draft; writing—review and editing. Marco DiBonaventura: Conceptualization; writing—original draft; writing—review and editing; methodology; data curation; formal analysis; validation; investigation. Sharon T. Sullivan: Conceptualization; methodology; data curation; formal analysis; validation; investigation; writing—original draft; writing—review and editing. Mohammad A. Chaudhary: Methodology; conceptualization; data curation; formal analysis; validation; writing—original draft; writing—review and editing. Didem Aydin: Conceptualization; methodology; data curation; formal analysis; writing—review and editing; writing—original draft; validation. Mohamad Mohty: Conceptualization; methodology; data curation; formal analysis; validation; writing—review and editing; writing—original draft.

Information on the MagnetisMM-3 study (NCT04649359) can be found at ClincialTrials.gov.

Nizar J. Bahlis reports honoraria from AbbVie, Amgen, Celgene, Genentech/Roche, GSK, Janssen, Karyopharm Therapeutics, Sanofi, and Takeda; consulting or advisory roles for Amgen, Celgene, Janssen, Karyopharm Therapeutics, Pfizer, Sanofi, and Takeda; and patents, royalties, or other intellectual property from Celgene and Janssen. Ajay K. Nooka reports honoraria from Adaptive Biotechnologies, Amgen, BeyondSpring Pharmaceuticals, Bristol-Myers Squibb/Celgene, Cellectar, Genzyme, GSK, Janssen Oncology, Karyopharm Therapeutics, Oncopeptides, ONK Therapeutics, Pfizer, Secura Bio, and Takeda; consulting or advisory roles for Adaptive Biotechnologies, Amgen, BeyondSpring Pharmaceuticals, Bristol-Myers Squibb, Cellectar, Genzyme, GSK, Janssen Oncology, Karyopharm Therapeutics, Oncopeptides, ONK Therapeutics, Pfizer, Secura Bio, and Takeda; research funding from Amgen, Arch Oncology, Bristol-Myers Squibb/Celgene, Cellectar, GSK, Janssen Oncology, Pfizer, and Takeda; and travel, accommodations, and expenses from GSK. Marco DiBonaventura, Sharon T. Sullivan, and Didem Aydin report employment and stock ownership with Pfizer. Mohammad A. Chaudhary reports employment with Pfizer. Mohamad Mohty reports honoraria from Amgen and Celgene; consulting or advisory roles for Adaptive Biotechnologies, GSK, Jazz Pharmaceuticals, MaaT Pharma, Novartis, Sanofi, and Xenikos; and speakers bureaus roles for Janssen, Jazz Pharmaceuticals, and Sanofi.

This study was conducted in accordance with the International Council for Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. The study protocol was approved by local or independent institutional review boards or ethics committees at participating sites.

This study was funded by Pfizer.

All the patients provided written informed consent.

Abstract Image

降低elranatumab给药频率对复发或难治性多发性骨髓瘤患者报告的结果的影响:来自MagnetisMM-3的结果
同样,两个队列的QLQ-C30疲劳评分在第16个月通常保持在或接近Q2W基线水平,在第18个月无显著恶化(图1E,F)。bcma初始患者的疼痛评分在第7个月保持在Q2W基线水平附近,在第10、16和18个月的数值上恶化幅度更大(图1G)。然而,第18个月较小的样本量可能会限制数据的可解释性。bcma暴露患者的疼痛评分在第6个月相对于Q2W基线出现短暂改善,然后从第7个月到第18个月返回并维持在Q2W基线附近(图1H)。来自mm特异性QLQ-MY20问卷的结果显示,在第16个月,两个队列的疾病症状评分保持在或接近Q2W基线水平(图2A,B)。在第18个月,bcma初始患者的改善数值较大,bcma暴露患者的恶化数值较大;然而,第18个月的专业医师患者数量较少,可能限制了这些数据的可解释性。副作用域的QLQ-MY20评分显示,bcma初治患者的Q2W基线水平到第16个月变化不大。在第18个月恶化可能是由于样本量小(图2C)。在第7个月,观察到bcma暴露患者的副作用域评分较Q2W基线有更大的改善;然而,域评分在第10个月稳定在Q2W基线水平附近,在第16个月改善,并维持到第18个月(图2D)。对于bcma初始患者,身体形象评分在第18个月保持在或接近Q2W基线水平(图2E)。在第10、13和16个月观察到bcma暴露患者PRO评分在数值上有更大的改善(图2F)。在第18个月观察到PRO评分无明显恶化,但样本量相当小。同样,两个队列的未来前景评分与第18个月的Q2W基线值基本一致(图2G,H)。对MagnetisMM-3研究中bcma初始和暴露的RRMM患者过渡到Q2W埃尔那他单抗剂量后的PROs的分析表明,HRQOL在这种转换后基本维持了18个月,包括疲劳、疼痛、疾病症状和总体QOL的测量,无论先前是否暴露于bcma导向治疗。在第18个月左右,一些领域的分数出现了较大的恶化或改善;然而,小样本量(≤6)使得任何解释都很困难。切换到较少频率给药对患者报告的生活质量和疾病症状的最小影响可能反映了疾病控制的维持和安全性的改善。切换到较少剂量的elranatamab的患者在报告的疼痛、疲劳或疾病症状方面没有恶化,并且副作用、生活质量、身体形象和未来视角域评分基本稳定。延长elranatamab的给药间隔限制了与医疗保健系统的接触天数,减少了患者协调治疗和前往医疗保健机构的时间在不影响双特异性抗体治疗的有效性或安全性的情况下减少接触天数可能会显著影响患者的生活质量并影响他们的治疗选择。结合其他优点,这些发现强调了定制给药方案的潜在益处,以提高患者满意度,同时不影响治疗结果或安全性。该分析的一个局限性是自我选择群体偏差。在MagnetisMM-3研究中,患者没有随机接受elranatamab Q2W;只有符合剂量转换标准的患者才有资格从QW剂量过渡到Q2W剂量。其次,本分析中的随访时间是可变的,因为它是患者何时符合资格标准并过渡到Q2W治疗的函数。并非所有患者在改用Q2W治疗后都有机会进行长时间的随访,导致较晚时间点的患者人数较少。因此,以后时间点的结果应该谨慎解释。总之,尽管一些PRO测量值偶尔会发生短暂的变化,但通过患者报告的功能和症状的测量来评估,从QW到Q2W的elranatamab给药计划的转换对患者的生活质量没有损害。大多数领域分数保持稳定超过1年。这些数据补充了临床获益和安全性不受Q2W给药频率的负面影响的研究结果,并进一步支持elranatamab治疗RRMM患者,无论先前是否接受bcma靶向治疗。Nizar J. Bahlis:概念化;方法;数据管理;调查;验证;正式的分析;原创作品草案;写作-审查和编辑。Ajay K。
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来源期刊
HemaSphere
HemaSphere Medicine-Hematology
CiteScore
6.10
自引率
4.50%
发文量
2776
审稿时长
7 weeks
期刊介绍: HemaSphere, as a publication, is dedicated to disseminating the outcomes of profoundly pertinent basic, translational, and clinical research endeavors within the field of hematology. The journal actively seeks robust studies that unveil novel discoveries with significant ramifications for hematology. In addition to original research, HemaSphere features review articles and guideline articles that furnish lucid synopses and discussions of emerging developments, along with recommendations for patient care. Positioned as the foremost resource in hematology, HemaSphere augments its offerings with specialized sections like HemaTopics and HemaPolicy. These segments engender insightful dialogues covering a spectrum of hematology-related topics, including digestible summaries of pivotal articles, updates on new therapies, deliberations on European policy matters, and other noteworthy news items within the field. Steering the course of HemaSphere are Editor in Chief Jan Cools and Deputy Editor in Chief Claire Harrison, alongside the guidance of an esteemed Editorial Board comprising international luminaries in both research and clinical realms, each representing diverse areas of hematologic expertise.
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