预约演示
更新于：2024-12-26
Ispectamab debotansine
更新于：2024-12-26
概要
基本信息
非在研机构 |
最高研发阶段临床1期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国) |
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结构/序列
Sequence Code 13410342L
来源: *****
Sequence Code 527694234H
来源: *****
关联
1
项与 Ispectamab debotansine 相关的临床试验NCT04036461
A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma
100 项与 Ispectamab debotansine 相关的临床结果
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100 项与 Ispectamab debotansine 相关的转化医学
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100 项与 Ispectamab debotansine 相关的专利（医药）
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15
项与 Ispectamab debotansine 相关的文献（医药）2024-09-01Med
How to rescue a DreaMM deferred …
Article
作者: Joseph, Nisha S. ; Lonial, Sagar ; Joseph, Nisha S
The recently published DreaMM-7 and -8 trials1,2 demonstrate the benefit of triplet combination regimens including the anti-BCMA antibody drug conjugate belantamab mafodotin. Here, we describe the findings of these trials including efficacy and safety data and provide commentary on the implications for future use of belantamab in the relapsed myeloma space.
2024-02-01Nature medicine1区 · 医学
Belantamab mafodotin, pomalidomide and dexamethasone in refractory multiple myeloma: a phase 1/2 trial
1区 · 医学
Article
作者: Mian, Hira ; McCurdy, Arleigh ; Reece, Donna ; Parkin, Stephen ; Kotb, Rami ; Trudel, Suzanne ; Su, Jiandong ; White, Darrell ; Chu, Michael P ; Khan, Aniba ; Louzada, Martha L ; Othman, Ibraheem ; Gul, Engin
Abstract:
Due to evolving treatment standards for newly diagnosed multiple myeloma, many patients will be triple-class exposed after initial relapses and have poor survival. Novel therapies and combinations are therefore required to improve outcomes. B cell maturation antigen (BCMA)-targeted biologics have emerged as an important new area of therapeutics for relapsed multiple myeloma. The two-part ALGONQUIN trial evaluated various doses and schedules of the anti-BCMA antibody–drug conjugate belantamab mafodotin plus pomalidomide and dexamethasone for patients who are lenalidomide refractory and proteosome inhibitor exposed. The primary endpoints, including evaluating dose-limiting toxicities, establishing the recommended Part 2 dose (RP2D) and overall response rate for patients treated at the RP2D, were met. Secondary efficacy endpoints included progression-free survival and overall survival. Patients treated on study (N = 87) had a median of three previous regimens and 55.2% were triple-class refractory. At the RP2D the most common adverse events were decrease in best-corrected visual acuity (71.1%), keratopathy (65.8%), fatigue (57.9%), infection (47.4%; 7.9% grade ≥3), neutropenia (39.5%) and thrombocytopenia (39.5%). For RP2D patients (n = 38), the overall response rate was 85.3%, ≥very good partial response 75.7% and estimated two-year progression-free survival 52.8% (95% confidence interval, 33.9% to 82.4%), at a median follow-up of 13.9 months. The RP2D schedule was associated with manageable antibody–drug conjugate-associated corneal adverse events and improved tolerability without compromising efficacy. Belantamab mafodotin plus pomalidomide and dexamethasone induced durable responses with promising overall survival in relapsed multiple myeloma, the results of which are yet to be confirmed in the phase 3 DREAMM-8 study. ClinicalTrials.gov Identifier: NCT03715478.
2023-03-01Oncology and therapy
Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP)
Article
作者: Aláez, Concepción ; Jimenez-Ubieto, Ana ; Alonso, Aránzazu ; Martínez-Chamorro, Carmen ; Alegre, Adrián ; Benzo, Gonzalo ; Bocanegra, Ana ; Martínez-López, Joaquín ; Askari, Elham ; Llorente, Laura ; Velasco, Alberto ; Aguado, Beatriz ; Alonso, Rafael ; Krsnik, Isabel ; Muñoz-Linares, Cristina ; Jiménez-Montes, Carmen ; Giménez, Eugenio ; Prieto, Elena ; Morales, Ana ; Iglesias, Rebeca ; Blanchard, María J ; Cuéllar, Clara
INTRODUCTION:
Belantamab mafodotin (BM) is a new anti-BCMA antibody-drug conjugate, recently approved for triple-class relapsed and refractory multiple myeloma (RRMM). We assessed real-world outcomes with BM in patients under the Spanish Expanded Access Program (EAP).
METHODS:
We conducted an observational, retrospective, multicenter study including RRMM patients who received ≥ 1 dose of BM (Nov 2019 to Jun 2021). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and incidence of treatment-emergent adverse events (TEAEs).
RESULTS:
Thirty-three patients were included with a median of 70 years of age (range, 46-79 years). Median time from diagnosis was 71 months (range, 10-858 months). Median prior lines was 5 (range, 3-8 lines); 90% of patients were triple-/quad-/penta-refractory; 48% showed high-risk cytogenetics. Median BM doses was 3 (range 1-16 doses), with a median follow-up of 11 months (6-15 months). ORR was 42.2% (≥ VGPR, 18.2%). Median PFS was 3 months (95% CI 0.92-5.08) in the overall population, and 11 months (HR 0.26; 95% CI 0.10-0.68) for patients who achieved ≥ PR. PFS was not significantly different according to age, cytogenetic risk, and prior therapy lines. OS was 424 days (95% CI 107-740). Non-hematological TEAEs (57.6% of patients; 30.3% ≥ G3) included keratopathy (51.5%; 21.2% ≥ G3) and patient-reported vision-related symptoms (45.5%). Keratopathy was resolved in 70.6% of patients. G3 hematological TEAEs was 18.2%, thrombocytopenia (21.2%). Dose reductions due to TEAEs: 30.3%; delays: 36.4%. Treatment discontinuation causes: progression (54.5%), toxicity (non-ocular; 6%/ocular; 6% /ocular + non-ocular toxicity; 3%), death (6%), and patient's decision (3%).
CONCLUSIONS:
BM showed relevant anti-myeloma activity in RRMM with a manageable safety profile. These results corroborate those observed in the BM pivotal trial.
100 项与 Ispectamab debotansine 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 复发性多发性骨髓瘤 | 临床1期 | 加拿大 | 2019-08-26 | |
| 复发性多发性骨髓瘤 | 临床1期 | 法国 | 2019-08-26 | |
| 复发性多发性骨髓瘤 | 临床1期 | 意大利 | 2019-08-26 | |
| 复发性多发性骨髓瘤 | 临床1期 | 西班牙 | 2019-08-26 | |
| 多发性骨髓瘤 | 临床1期 | 美国 | - |
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