A phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors

Abstract Delta-like protein 3 (DLL3) is highly expressed in solid tumors, including neuroendocrine carcinomas/neuroendocrine tumors (NEC/NET). Rovalpituzumab tesirine (Rova-T) is a DLL3-targeting antibody-drug conjugate. Patients with NECs and other advanced DLL3-expressing tumors were enrolled in t...

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Autores principales:	Aaron S. Mansfield, David S. Hong, Christine L. Hann, Anna F. Farago, Himisha Beltran, Saiama N. Waqar, Andrew E. Hendifar, Lowell B. Anthony, Matthew H. Taylor, Alan H. Bryce, Scott T. Tagawa, Karl Lewis, Jiaxin Niu, Christine H. Chung, James M. Cleary, Michael Rossi, Carrianne Ludwig, Ricardo Valenzuela, Yan Luo, Rahul Aggarwal
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/41cea5032a0d44ac9ceef9a9bed44b7a
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spelling	oai:doaj.org-article:41cea5032a0d44ac9ceef9a9bed44b7a2021-12-02T14:53:40ZA phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors10.1038/s41698-021-00214-y2397-768Xhttps://doaj.org/article/41cea5032a0d44ac9ceef9a9bed44b7a2021-08-01T00:00:00Zhttps://doi.org/10.1038/s41698-021-00214-yhttps://doaj.org/toc/2397-768XAbstract Delta-like protein 3 (DLL3) is highly expressed in solid tumors, including neuroendocrine carcinomas/neuroendocrine tumors (NEC/NET). Rovalpituzumab tesirine (Rova-T) is a DLL3-targeting antibody-drug conjugate. Patients with NECs and other advanced DLL3-expressing tumors were enrolled in this phase I/II study (NCT02709889). The primary endpoint was safety. Two hundred patients were enrolled: 101 with NEC/NET (large-cell NEC, gastroenteropancreatic NEC, neuroendocrine prostate cancer, and other NEC/NET) and 99 with other solid tumors (melanoma, medullary thyroid cancer [MTC], glioblastoma, and other). The recommended phase II dose (RP2D) was 0.3 mg/kg every 6 weeks (q6w) for two cycles. At the RP2D, grade 3/4 adverse events included anemia (17%), thrombocytopenia (15%), and elevated aspartate aminotransferase (8%). Responses were confirmed in 15/145 patients (10%) treated at 0.3 mg/kg, including 9/69 patients (13%) with NEC/NET. Rova-T at 0.3 mg/kg q6w had manageable toxicity, with antitumor activity observed in patients with NEC/NET, melanoma, MTC, and glioblastoma.Aaron S. MansfieldDavid S. HongChristine L. HannAnna F. FaragoHimisha BeltranSaiama N. WaqarAndrew E. HendifarLowell B. AnthonyMatthew H. TaylorAlan H. BryceScott T. TagawaKarl LewisJiaxin NiuChristine H. ChungJames M. ClearyMichael RossiCarrianne LudwigRicardo ValenzuelaYan LuoRahul AggarwalNature PortfolioarticleNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENnpj Precision Oncology, Vol 5, Iss 1, Pp 1-7 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Aaron S. Mansfield David S. Hong Christine L. Hann Anna F. Farago Himisha Beltran Saiama N. Waqar Andrew E. Hendifar Lowell B. Anthony Matthew H. Taylor Alan H. Bryce Scott T. Tagawa Karl Lewis Jiaxin Niu Christine H. Chung James M. Cleary Michael Rossi Carrianne Ludwig Ricardo Valenzuela Yan Luo Rahul Aggarwal A phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors
description	Abstract Delta-like protein 3 (DLL3) is highly expressed in solid tumors, including neuroendocrine carcinomas/neuroendocrine tumors (NEC/NET). Rovalpituzumab tesirine (Rova-T) is a DLL3-targeting antibody-drug conjugate. Patients with NECs and other advanced DLL3-expressing tumors were enrolled in this phase I/II study (NCT02709889). The primary endpoint was safety. Two hundred patients were enrolled: 101 with NEC/NET (large-cell NEC, gastroenteropancreatic NEC, neuroendocrine prostate cancer, and other NEC/NET) and 99 with other solid tumors (melanoma, medullary thyroid cancer [MTC], glioblastoma, and other). The recommended phase II dose (RP2D) was 0.3 mg/kg every 6 weeks (q6w) for two cycles. At the RP2D, grade 3/4 adverse events included anemia (17%), thrombocytopenia (15%), and elevated aspartate aminotransferase (8%). Responses were confirmed in 15/145 patients (10%) treated at 0.3 mg/kg, including 9/69 patients (13%) with NEC/NET. Rova-T at 0.3 mg/kg q6w had manageable toxicity, with antitumor activity observed in patients with NEC/NET, melanoma, MTC, and glioblastoma.
format	article
author	Aaron S. Mansfield David S. Hong Christine L. Hann Anna F. Farago Himisha Beltran Saiama N. Waqar Andrew E. Hendifar Lowell B. Anthony Matthew H. Taylor Alan H. Bryce Scott T. Tagawa Karl Lewis Jiaxin Niu Christine H. Chung James M. Cleary Michael Rossi Carrianne Ludwig Ricardo Valenzuela Yan Luo Rahul Aggarwal
author_facet	Aaron S. Mansfield David S. Hong Christine L. Hann Anna F. Farago Himisha Beltran Saiama N. Waqar Andrew E. Hendifar Lowell B. Anthony Matthew H. Taylor Alan H. Bryce Scott T. Tagawa Karl Lewis Jiaxin Niu Christine H. Chung James M. Cleary Michael Rossi Carrianne Ludwig Ricardo Valenzuela Yan Luo Rahul Aggarwal
author_sort	Aaron S. Mansfield
title	A phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors
title_short	A phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors
title_full	A phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors
title_fullStr	A phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors
title_full_unstemmed	A phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors
title_sort	phase i/ii study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/41cea5032a0d44ac9ceef9a9bed44b7a
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A phase I/II study of rovalpituzumab tesirine in delta-like 3—expressing advanced solid tumors

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