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Maximilian Johannes Hochmair

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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      63P - Real-life experience with the implementation of DLL3 staining and the subsequent treatment with rovalpituzumab tesirine in heavily pretreated SCLC patients (ID 530)

      12:30 - 13:00  |  Presenting Author(s): Maximilian Johannes Hochmair

      • Abstract


      Around 15% of newly diagnosed lung cancer patients are characterized as SCLC mostly with extensive stage disease. While SCLC may be responsive to 1st or 2nd line chemotherapy, there is no approved drug for the 3rd line with guidelines recommending best supportive care. Rovalpituzumab Teserine (Rova-T) is a novel first–in-class antibody-drug conjugate and targets the delta-like protein 3 (DLL3), a newly discovered target highly expressed in SCLC and other high-grade neuroendocrine carcinomas. ROVA-T showed an encouraging single-agent anti-tumor activity and manageable safety profile in Phase 1 and 2 studies. The present study is a retrospective analysis to evaluate DLL3 testing and real-life experience with ROVA-T for patients with an unmet medical need after failure of at least 2 systemic treatments.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      DLL3 Immunohistochemistry (VENTANA DLL3 (SP347) Assay) was performed for 68 Patients with high grade neuroendocrine carcinoma (61 SCLC and 7 LCNEC). The percentages of stained tumor cells was determined - TC-counts of < 25% were interpreted as negative, counts of ≥ 25 to < 75% as positive and ≥75% as highly positive. 16 patients were eligible for treatment with Rova-T and received at least 1 of 2 planned cycles with a dose of 0.3 mg/kg.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      DLL3 staining was seen in most of the patients with high grade neuroendocrine carcinoma, 49 specimens (72.1%) were interpreted as highly positive, 10 specimens (14.7%) were considered positive. 9 (13.2 %) were considered negative, 4 (5,9%) of them showed no staining for IHC. All eligible patients had an ED with an ECOG of 0-1. 2 of the treated patients were DLL3 negative, 4 positive and 10 were highly positive. Of the 2 planned cycles 7 patients received both and 9 received only one due to disease progression or adverse events. Overall, 4 patients (25%) showed a PR, 4 (25%) had SD and 8 developed disease progression (50%). Side effects were manageable.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      DLL3 staining is frequent in SCLC patients but further studies are needed to proof it to be a useful predictive biomarker. Rova-T seems to be an option for ED SCLC patients in later lines with a high unmet need for treatment and showed a clinical benefit in selected patients with a manageable safety profile.

      b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study

      The authors.

      213f68309caaa4ccc14d5f99789640ad Funding

      Has not received any funding.

      682889d0a1d3b50267a69346a750433d Disclosure

      All authors have declared no conflicts of interest.