Preliminary Safety and Efficacy of Rovalpituzumab Tesirine in Patients with Delta-Like Protein 3-Expressing Advanced Solid Tumors

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Introduction: Rovalpituzumab tesirine (Rova-T™) is an antibody-drug conjugate targeting delta-like protein 3 (DLL3), an atypical Notch receptor family ligand expressed in high-grade neuroendocrine carcinomas (NECs).

Aim(s): This is a Phase 1/2, open-label, multicenter study (NCT02709889) to determine safety/tolerability of Rova-T in 8 cohorts: malignant melanoma, medullary thyroid cancer (MTC), glioblastoma (GBM), large cell NEC (LCNEC), neuroendocrine prostate cancer (NEPC), high-grade gastroenteropancreatic NEC (GEP NEC), other NEC, and other solid tumors.

Materials and methods: Eligible adults have a histologically confirmed, DLL3-expressing, advanced solid tumor relapsed/refractory to standard therapy, and no prior exposure to pyrrolobenzodiazepine-based drug. A 3+3 dose escalation is used in each cohort, at doses 0.2-0.4 mg/kg of Rova-T until a maximum tolerated dose (MTD) is determined.

Conference: 15th Annual ENETSConcerence (2018)

Presenting Author: Mansfield A

Authors: Mansfield A, Aggarwal R, Beltran H, Farago A, Hann C,

Keywords: Rovalpituzumab tesirine, DLL3, neuroendocrine tumors, antibody-drug conjugate,