NPJ precision oncology · 2021
A phase I/II study of rovalpituzumab tesirine in delta-like 3-expressing advanced solid tumors.
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Mansfield Aaron S, Hong David S, Hann Christine L, Farago Anna F, Beltran Himisha, Waqar Saiama N, Hendifar Andrew E, Anthony Lowell B, Taylor Matthew H, Bryce Alan H, Tagawa Scott T, Lewis Karl, Niu Jiaxin, Chung Christine H, Cleary James M, Rossi Michael, Ludwig Carrianne, Valenzuela Ricardo, Luo Yan, Aggarwal Rahul
Аннотация
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.