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Stacy Osbaugh

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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
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      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

      • Abstract
      • Slides


      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

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      8eea62084ca7e541d918e823422bd82e Conclusion

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