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C. Yu



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    P2.01 - Poster Session with Presenters Present (ID 461)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Biology/Pathology
    • Presentations: 1
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      P2.01-089 - Predictive Value of AEG-1 Expression on Tumor Response by Liquid Biopsy in NSCLC Patients Treated with Chemotherapy (ID 5679)

      14:30 - 15:45  |  Author(s): C. Yu

      • Abstract

      Background:
      AEG‑1 is important in the aggressiveness of NSCLC and also contributes to induce chemoresistance in treatment of NSCLC. In this study, we will assess the predictive and prognostic values of AEG-1 expression on tumor response and survival according to mRNA concentration by liquid biopsy in NSCLC patients treated with chemotherapy.

      Methods:
      Patients were diagnosed with a advanced NSCLC (stage IIIB and IV). Patients were enrolled to be treated by chemotherapy as first-line treatment or for metastatic or recurrent disease with Eastern Cooperative Oncology Group (ECOG) performance status of 0–1. All patients underwent blood sampling before any cancer treatment and at first response evaluation. Response to chemotherapy was assessed using RECIST criteria. mRNA was extracted from plasma samples using the QIAamp Circulating Nucleic Acid Kit (Qiagen, Valencia, CA, USA) and quantification of mRNA was performed by real-time PCR (ABI 7900) with SYBR GREEN reagent expression assay for AEG-1.

      Results:
      A total of 12 patients (9 male and 3 female) with advanced NSCLC received platinum based doublets chemotherapy. Chemotherapy regimens included 8 cisplatin and 4 carboplatin with 5 pemetrexed, 4 paclitaxel, 2 gemcitabine and 1 vinorelbine. 7 of 12 (58.3%) were adenocarcinoma. The initial response rate of chemotherapy included 6 partial responses, 1 stable disease and 5 progressive disease. The expression level of AEG-1 in patients with disease progression after chemotherapy increased significantly compared with the expression level at pre-chemotherapy (AEG-1, relative quantification of mRNA, post-progression, range: 2.14 - 8.61, p = 0.035). In the group of patients with responsive chemotherapy, the mRNA expression level of AEG-1 was not increased compared to the baseline expression (Figure 1). Figure 1



      Conclusion:
      This result suggests that mRNA concentration of AEG-1 from liquid biopsy could be a predictive biomarker of tumor response. Increased expression of AEG-1 contributed to the chemoresistance and caused lung cancer progression.

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    P3.02a - Poster Session with Presenters Present (ID 470)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02a-025 - PROs With Ceritinib Versus Chemotherapy in Patients With Previously Untreated ALK-rearranged Nonsquamous NSCLC (ASCEND-4) (ID 5128)

      14:30 - 15:45  |  Author(s): C. Yu

      • Abstract

      Background:
      Here, we present the patient-reported outcomes (PROs) of ceritinib versus chemotherapy as first-line treatment for advanced ALK+ NSCLC.

      Methods:
      Untreated, ALK+, advanced, nonsquamous NSCLC patients (N=376) were randomized (1:1) to ceritinib 750 mg/day (n=189) or chemotherapy (n=187; [pemetrexed 500 mg/m[2 ]plus cisplatin 75 mg/m[2] or carboplatin AUC 5-6] for 4 cycles followed by maintenance pemetrexed). PROs were assessed using EORTC quality-of-life questionnaire (QLQ-C30), the lung cancer module (QLQ-LC13), Lung Cancer Symptom Scale (LCSS), and EQ-5D.

      Results:
      Median treatment exposure was 66.4 weeks for ceritinib and 26.9 weeks for chemotherapy. PRO compliance was high, ≥80% at most timepoints. Ceritinib significantly prolonged time to deterioration of lung cancer-specific symptoms (pain, dyspnea, and cough) versus chemotherapy in both LCSS and QLQ-LC13 instruments (composite endpoints for LCSS, HR=0.61 [0.41, 0.90]; and QLQ-LC13, HR=0.48 [0.34, 0.69]). Time to deterioration in LC13 questionnaire was significantly longer with ceritinib versus chemotherapy (23.6 [20.7, NE] vs 12.6 [8.9, 14.9] months) (Table). In the QLQ-C30 instrument, 4 of 5 functional domains and 6 of 9 symptom scales improved with ceritinib (P< 0.05); 2 scales related to gastrointestinal symptoms indicated deterioration for ceritinib. In agreement with most other scales showing symptom improvement, ceritinib demonstrated significant improvements in Global Health Status/QoL in the same instrument (QLQ-C30, P<0.001) as well as for EQ-5D-5L index (P<0.001) and EQ-5D-5L VAS (P<0.05 from cycle 13 until 49). Figure 1



      Conclusion:
      Untreated ALK+ NSCLC patients experienced significantly greater improvements in lung cancer-specific symptoms on treatment with ceritinib. General health status was significantly improved with ceritinib versus chemotherapy. Overall, PRO results from all 4 instruments independently showed improvements highlighting the consistency and robustness of these findings.

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    PL03 - Presidential Symposium (ID 428)

    • Event: WCLC 2016
    • Type: Plenary
    • Track:
    • Presentations: 1
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      PL03.07 - First-line Ceritinib Versus Chemotherapy in Patients With ALK-rearranged (ALK+) NSCLC: A Randomized, Phase 3 Study (ASCEND-4) (Abstract under Embargo until December 6, 7:00 CET) (ID 4987)

      08:35 - 10:25  |  Author(s): C. Yu

      • Abstract
      • Presentation
      • Slides

      Background:
      Here, we report results of ceritinib versus chemotherapy as first-line treatment for advanced ALK+ NSCLC.

      Methods:
      Untreated ALK+ (IHC confirmed), advanced, nonsquamous NSCLC patients (N=376; median age, 54 years) were randomized (1:1) to ceritinib 750 mg/day (n=189 [59 with brain metastases (BM)]) or chemotherapy (n=187 [62 with BM]; [pemetrexed 500 mg/m[2] plus cisplatin 75 mg/m[2] or carboplatin AUC 5-6] for 4 cycles followed by maintenance pemetrexed), stratified by WHO PS (0 vs 1-2), BM at screening, and prior neo-/adjuvant chemotherapy. Crossover from chemotherapy to ceritinib was allowed at progression (n=80 crossed-over).

      Results:
      Median treatment exposure was 66.4 weeks for ceritinib and 26.9 weeks for chemotherapy. Median follow-up duration was 19.7 months (randomization to cut-off date). The study met its primary objective, with ceritinib demonstrating statistically significant improvement in BIRC PFS (RECIST 1.1; median, 16.6 [12.6, 27.2] vs 8.1 months [5.8, 11.1], HR=0.55, P<0.001) versus chemotherapy. OS was immature (HR, 0.73 [0.50, 1.08]; P=0.056) with 42.3% of required events at interim analysis. ORR (BIRC, 72.5% vs 26.7%) and DOR (BIRC, median, 23.9 vs 11.1 months) were also higher with ceritinib versus chemotherapy. Among patients with measurable baseline BM and ≥1 postbaseline assessment, intracranial ORR (BIRC neuroradiologist; modified RECIST v1.1) was higher with ceritinib (72.7% [49.8, 89.3] vs 27.3% [10.7, 50.2]) versus chemotherapy (Table). Most common AEs (>50%) with ceritinib were diarrhea (84.7%), nausea (68.8%), vomiting (66.1%), ALT increase (60.3%), and AST increase (52.9%). Overall, 5.3% ceritinib- and 11.4% chemotherapy-treated patients discontinued due to AEs suspected to be drug-related. Figure 1



      Conclusion:
      First-line ceritinib achieved statistically significant and clinically meaningful improvement in median PFS with an estimated 45% risk reduction in advanced ALK+ NSCLC versus chemotherapy including maintenance. Moreover, ceritinib achieved high and durable systemic responses and high OIRR in patients with measurable BM. Safety profile of ceritinib is consistent with previously reported.

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