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L. Caffrey
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P1.04 - Clinical Design, Statistics and Clinical Trials (ID 690)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Clinical Design, Statistics and Clinical Trials
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.04-006 - Rovalpituzumab Tesirine vs Topotecan in Patients with Advanced Small Cell Lung Cancer Following 1<sup>st</sup> Line Chemotherapy (ID 8393)
09:30 - 09:30 | Author(s): L. Caffrey
- Abstract
Background:
Small cell lung cancer (SCLC) represents ~15% of lung cancers. Patients (pts) are staged with limited or extensive stage disease (ES). ES standard therapy consists of a platinum-based therapy + a second agent (etoposide). Initial response rates are high but not durable. Treatment for relapsed pts is limited, but includes topotecan. However, efficacy of topotecan is suboptimal and there is a high unmet need in this population. Delta-like protein 3 (DLL3) is an atypical Notch receptor family ligand identified as a target in SCLC and neuroendocrine carcinomas (NECs). DLL3 is highly expressed in SCLC and NECs but not normal tissue. Rovalpituzumab tesirine (Rova-T™) is an antibody-drug conjugate composed of a DLL3-targeting IgG1 monoclonal antibody tethered to a toxic DNA crosslinker. Rova-T has antitumor activity in relapsed ES SCLC pts, and was well-tolerated[1]. Thus, we are investigating Rova-T vs topotecan as a 2[nd] line therapy in advanced SCLC.
Method:
This is a Phase 3, randomized, open-label, multicenter study (NCT03061812) to assess efficacy, safety, and tolerability of Rova-T vs topotecan. Approximately 411 pts will be enrolled and randomized 2:1 between 2 arms. Arm A regimen: 0.3 mg/kg Rova-T intravenous (IV) on Day 1 + 8 mg dexamethasone orally, twice daily on Day -1, 1 and 2 of a 42-day cycle; administered for 2 cycles with up to 2 additional cycles permitted. Arm B: 1.5 mg/m[2] topotecan (or per local label) IV on Days 1-5 of each 21-day cycle; administered until disease progression. Pt eligibility: ≥ 18 years; confirmed, advanced/metastatic SCLC with first disease progression following frontline standard therapy; DLL3-high tumor expression; ECOG 0-1; no prior exposure to a pyrrolobenzodiazepine-based drug or topotecan, irinotecan, or other topoisomerase I inhibitor. Primary objectives: to determine if Rova-T improves objective response rate and overall survival vs topotecan. Secondary objectives: to assess if Rova-T improves progression-free survival vs topotecan; to compare duration of objective response between arms; and to assess effect on patient-reported outcomes. 1. Rudin et al., Lancet Oncol, 2016.
Result:
Section not applicable
Conclusion:
Section not applicable
