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P1.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 944)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Presentations: 1
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
P1.12-06b - Rovalpituzumab Tesirine vs Topotecan in Patients with Advanced Small Cell Lung Cancer Following 1<sup>st</sup> Line Chemotherapy (ID 13438)
16:45 - 18:00 | Author(s): Scott Gulbranson
Small cell lung cancer (SCLC) represents ~15% of lung cancers. Standard therapy most often consists of a platinum-based therapy + a second agent (etoposide). Initial response rates are high but not durable. Treatment for relapsed patients 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 SCLC patients, and was well-tolerated1. Thus, we are investigating Rova-T vs topotecan as a 2nd line therapy in advanced SCLC.a9ded1e5ce5d75814730bb4caaf49419 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 patients 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/m2 topotecan (or per local label) IV on Days 1-5 of each 21-day cycle; administered until disease progression. Patient 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. Efficacy endpoints include progression free survival, overall survival, objective response rate, duration of response, and patient-reported outcomes.
1. Rudin et al., Lancet Oncol, 2016.4c3880bb027f159e801041b1021e88e8 Result
Section not applicable8eea62084ca7e541d918e823422bd82e Conclusion
Section not applicable6f8b794f3246b0c1e1780bb4d4d5dc53
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