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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
P1.12-06a - Rovalpituzumab Tesirine Maintenance Therapy Following 1st Line Platinum‑Based Chemotherapy in Small Cell Lung Cancer (ID 13432)
16:45 - 18:00 | Author(s): Stacy Osbaugh
Small Cell Lung Cancer (SCLC) embodies 15-20% of lung cancers. Patients are staged with either limited or extensive disease (ED); the standard front-line treatment for the latter is chemotherapy with carbo- or cisplatin combined with etoposide or irinotecan. Response rates are high with limited duration. Recurrence may be attributable to chemo-resistant tumor initiating cells (TICs). Delta-like protein 3 (DLL3) is an inhibitory Notch receptor ligand identified as a novel target in SCLC TICs. DLL3 is highly expressed in SCLC but not normal tissue. Rovalpituzumab tesirine (Rova-T™) is an antibody-drug conjugate composed of a DLL3-targeting IgG1 monoclonal antibody tethered to a DNA cross-linking toxin. Rova-T has shown activity in recurrent/relapsed ED SCLC patients1. Given DLL3 expression in TICs, exploration of Rova-T front-line maintenance strategies in ED SCLC is warranted. The postulated mechanism of action of Rova-T and its clinical activity indicate potential to improve progression-free and overall survival in this setting.a9ded1e5ce5d75814730bb4caaf49419 Method
This is a Phase 3, randomized, double-blind, placebo-controlled, international study (NCT03033511, no patients enrolled yet as of 7 February 2017). Approximately 740 ED SCLC patients will be enrolled to include ~480 patients with high DLL3 expression. Eligibility: patients ≥ 18 years; histologically or cytologically confirmed ED SCLC with ongoing clinical benefit (complete/partial response or stable disease) after 4 cycles of 1st line platinum-based therapy; definitively treated CNS metastases allowed; > 3 but ≤ 9 wks between the administration of the last cycle of platinum-based chemotherapy and randomization; available tumor tissue for DLL3 expression testing; ECOG performance score 0-1. Patients will be randomly assigned 1:1 to receive 0.3 mg/kg Rova-T or placebo on Day 1 of each 6-wk cycle, omitting every 3rd cycle. Primary objectives: determine if Rova-T improves progression-free and overall survival. Secondary objectives: assess Rova-T antitumor activity by determining objective response rate, clinical benefit rate, duration of response, and changes in patient reported outcomes.
1. Rudin et al., Lancet Oncol, 2016.4c3880bb027f159e801041b1021e88e8 Result
Section not applicable8eea62084ca7e541d918e823422bd82e Conclusion
Section not applicable6f8b794f3246b0c1e1780bb4d4d5dc53
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