Gabriel N. Mannis, Camille N. Abboud, Naval G. Daver, Guru Subramanian Guru Murthy, Eunice S. Wang, Terrence J. Bradley, George Yaghmour, Pankit Vachhani, Suresh Kumar Balasubramanian, Chong Chyn Chua, Chun Yew Fong, Adam S. Asch, Mei Dong, Shuang Li, Taravat Bagheri, Parul Doshi, Paresh Vyas, Monzr M. Al Malki
{"title":"美洛单抗联合治疗急性髓性白血病的2期多组研究","authors":"Gabriel N. Mannis, Camille N. Abboud, Naval G. Daver, Guru Subramanian Guru Murthy, Eunice S. Wang, Terrence J. Bradley, George Yaghmour, Pankit Vachhani, Suresh Kumar Balasubramanian, Chong Chyn Chua, Chun Yew Fong, Adam S. Asch, Mei Dong, Shuang Li, Taravat Bagheri, Parul Doshi, Paresh Vyas, Monzr M. Al Malki","doi":"10.1002/jha2.70051","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Introduction</h3>\n \n <p>This phase 2 study evaluated magrolimab+venetoclax (VEN)+azacitidine (AZA) in untreated, unfit acute myeloid leukaemia (AML) and magrolimab+mitoxantrone+etoposide+cytarabine in relapsed/refractory (R/R) AML.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Endpoints included complete remission rate (CRR), overall response rate (ORR), overall survival (OS) and safety.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Eighteen and 36 patients were enrolled into the unfit and R/R AML arms, respectively. CRR was 38.9% and 25.0%, ORR was 66.7% and 38.9%, and median OS was 15.3 and 10.5 months in the unfit AML and R/R AML arms, respectively. No dose-limiting toxicities or magrolimab-related deaths occurred.</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Magrolimab was safely combined with existing AML therapies with no new safety signals.</p>\n </section>\n \n <section>\n \n <h3> Clinical Trial Registration</h3>\n \n <p>This trail was registered at <span>www.clinicaltrials.gov</span> as NCT04778410.</p>\n </section>\n </div>","PeriodicalId":72883,"journal":{"name":"EJHaem","volume":"6 3","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jha2.70051","citationCount":"0","resultStr":"{\"title\":\"Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Acute Myeloid Leukaemia\",\"authors\":\"Gabriel N. Mannis, Camille N. Abboud, Naval G. Daver, Guru Subramanian Guru Murthy, Eunice S. Wang, Terrence J. Bradley, George Yaghmour, Pankit Vachhani, Suresh Kumar Balasubramanian, Chong Chyn Chua, Chun Yew Fong, Adam S. Asch, Mei Dong, Shuang Li, Taravat Bagheri, Parul Doshi, Paresh Vyas, Monzr M. Al Malki\",\"doi\":\"10.1002/jha2.70051\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Introduction</h3>\\n \\n <p>This phase 2 study evaluated magrolimab+venetoclax (VEN)+azacitidine (AZA) in untreated, unfit acute myeloid leukaemia (AML) and magrolimab+mitoxantrone+etoposide+cytarabine in relapsed/refractory (R/R) AML.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>Endpoints included complete remission rate (CRR), overall response rate (ORR), overall survival (OS) and safety.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Eighteen and 36 patients were enrolled into the unfit and R/R AML arms, respectively. CRR was 38.9% and 25.0%, ORR was 66.7% and 38.9%, and median OS was 15.3 and 10.5 months in the unfit AML and R/R AML arms, respectively. No dose-limiting toxicities or magrolimab-related deaths occurred.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>Magrolimab was safely combined with existing AML therapies with no new safety signals.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Clinical Trial Registration</h3>\\n \\n <p>This trail was registered at <span>www.clinicaltrials.gov</span> as NCT04778410.</p>\\n </section>\\n </div>\",\"PeriodicalId\":72883,\"journal\":{\"name\":\"EJHaem\",\"volume\":\"6 3\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-05-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jha2.70051\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EJHaem\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/jha2.70051\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EJHaem","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/jha2.70051","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Acute Myeloid Leukaemia
Introduction
This phase 2 study evaluated magrolimab+venetoclax (VEN)+azacitidine (AZA) in untreated, unfit acute myeloid leukaemia (AML) and magrolimab+mitoxantrone+etoposide+cytarabine in relapsed/refractory (R/R) AML.
Methods
Endpoints included complete remission rate (CRR), overall response rate (ORR), overall survival (OS) and safety.
Results
Eighteen and 36 patients were enrolled into the unfit and R/R AML arms, respectively. CRR was 38.9% and 25.0%, ORR was 66.7% and 38.9%, and median OS was 15.3 and 10.5 months in the unfit AML and R/R AML arms, respectively. No dose-limiting toxicities or magrolimab-related deaths occurred.
Conclusion
Magrolimab was safely combined with existing AML therapies with no new safety signals.
Clinical Trial Registration
This trail was registered at www.clinicaltrials.gov as NCT04778410.
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