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Endocrine and neuroendocrine tumours

3138 - Preliminary Safety and Efficacy of Rovalpituzumab Tesirine in Patients With Delta-Like Protein 3-Expressing Advanced Solid Tumors


11 Sep 2017


Endocrine and neuroendocrine tumours


Clinical Research;  Endocrine Tumours


Rahul Aggarwal


Annals of Oncology (2017) 28 (suppl_5): v142-v157. 10.1093/annonc/mdx368


R. Aggarwal1, A. Mansfield2, H. Beltran3, A.F. Farago4, C.L. Hann5, F. Kaye6, K. Lewis7, J. Niu8, S. Richey9, D. Smith10, H.P. Soares11, A. Spira12, M. Taylor13, S.N. Waqar14, S. Lally15, M. Rossi15, L. Saunders15, S.J. Dylla15, E. Kavalerchik15, L. Anthony16

Author affiliations

  • 1 Division Of Hematology/oncology, University of California at San Francisco, 94143 - San Francisco/US
  • 2 Division Of Medical Oncology, Mayo Clinic, 55905 - Rochester/US
  • 3 Division Of Hematology And Medical Oncology, Weill Cornell Medical College, 10021 - New York/US
  • 4 Thoracic Oncology, Massachusetts General Hospital, Boston/US
  • 5 Oncology, Johns Hopkins University, 21231 - Baltimore/US
  • 6 Division Of Hematology And Oncology, University of Florida, Gainesville/US
  • 7 Division Of Medical Oncology, University Of Colorado, 80045 - Aurora/US
  • 8 Hematology/oncology, Banner MD Anderson Cancer Center, Gilbert/US
  • 9 Hematology, Texas Oncology, Fort Worth/US
  • 10 Oncology/hematology, Compass Oncology, Vancouver/US
  • 11 Medical Oncology, Moffitt Cancer Center, Tampa/US
  • 12 Oncology, Virginia Cancer Specialists Research Institute, Fairfax/US
  • 13 Medical Oncology, Oregon Health and Science University, Portland/US
  • 14 Division Of Oncology, Washington University School of Medicine, St. Louis/US
  • 15 Clinical Development, AbbVie Stemcentrx LLC, South San Francisco/US
  • 16 Division Of Medical Oncology, University of Kentucky Chandler Medical Center, Lexington/US


Abstract 3138


Delta-like protein 3 (DLL3) is an atypical Notch receptor family ligand expressed in high-grade neuroendocrine carcinomas (NECs), but not in normal tissue. Rovalpituzumab tesirine (Rova-T™) is an antibody-drug conjugate targeting DLL3. A Phase 1 study of Rova-T in small cell lung cancer showed encouraging antitumor activity in patients (pts) with DLL3 expression, and was well-tolerated1. Rova-T may also be active in other DLL3-expressing tumors.


This is a Phase 1/2, open-label, multicenter study (NCT02709889) to determine safety and 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. Eligible adults have a histologically confirmed, DLL3-expressing, advanced solid tumor relapsed/refractory to standard therapy, and no prior exposure to a pyrrolobenzodiazepine-based drug. A 3 + 3 dose escalation is used in each cohort, at doses 0.2-0.4 mg/kg of Rova-T administered intravenously on Day 1 of each 42-day cycle, and proceeding until a maximum tolerated dose (MTD) is determined. A 2-stage design will be used for disease-specific expansion cohorts.


As of 3 April 2017, 31 pts (2 melanoma, 2 MTC, 3 GBM, 3 LCNEC, 3 NEPC, 3 GEP NEC, 10 other NEC, 5 other solid tumor) have been treated (26 pts at 0.2 mg/kg, 5 pts at 0.3 mg/kg Rova-T). The MTD has not been reached. Twenty-six pts (84%) had an adverse event (AE), and only 3/31 pts (10%) had a Grade 3+ AE deemed to be related to Rova-T. Common AEs were fatigue (32%), nausea (29%), and constipation (23%). Four pts had serosal effusions, 2 (6%) of which were assessed to be drug-related, and 3 pts (10%) had adverse skin reactions. Ten pts (32%) discontinued treatment, 5 for progressive disease and 4 due to AEs. Eleven pts have had post-baseline tumor assessments, and anti-tumor activity has been observed in multiple disease cohorts.


Preliminary safety and efficacy data of Rova-T warrant continued study in these disease populations, and will be updated at time of presentation. 1. Rudin et al., Lancet Oncol 2016.

Clinical trial identification


Legal entity responsible for the study

AbbVie Stemcentrx


AbbVie Stemcentrx


A. Mansfield: Consulting to Genentech, BMS and Trovagene with honoraria provided to institution. H. Beltran, K. Lewis: Research funding from AbbVie Stemcentrx. A.F. Farago: Consulting or advisory role for AbbVie, Pharmamar, Merrimack Pharmaceuticals, Takeda, Intervention Insights. Honorarium from Foundation Medicine. C.L. Hann: Advisory board for AbbVie Stemcentrx and BMS. Research funding from GlaxoSmithKline and Merrimack Pharmaceuticals. S. Richey: Employee of Texas Oncology. Consulting or advisory role for Exelixis, Pfizer, Prometheus and Sanofi. Research funding from Novartis, BMS, Eisai, Genentech/Roche, GSK, and AbbVie. D. Smith: Research funding from US Oncology. H.P. Soares: Advisory board for Cornerstone Pharmaceuticals. Research funding from Novartis. Consultant fees/honoraria for Ipsen. A. Spira: Consultant for AbbVie. Research funding from AbbVie (to institution). S. Lally, M. Rossi, L. Saunders, S.J. Dylla, E. Kavalerchik: Employee of AbbVie Stemcentrx and may own stock. L. Anthony: Research funding from AbbVie Stemcentrx, Lexicon Pharmaceuticals, Novartis, Markey Cancer Center Foundation. All other authors have declared no conflicts of interest.

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