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Akira Inoue



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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-20 - Phase III Study Comparing Gefitinib (G) to Gefitinib Combined with Carboplatin and Pemetrexed (GCP) for NSCLC with EGFR Mutations (NEJ009). (ID 11263)

      16:45 - 18:00  |  Author(s): Akira Inoue

      • Abstract
      • Slides

      Background

      Although EGFR-TKI alone has been a standard first-line treatment for patients with advanced NSCLC with EGFR mutations, our phase II study (NEJ005) showed promising efficacy of GCP. NEJ009, an open-label, randomized phase III study, was conducted to evaluate the superiority of GCP vs G in progression-free survival (PFS), PFS2, and overall survival (OS).

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with newly diagnosed stage III/IV/recurrent NSCLC harboring EGFR activating mutations (exon 19 deletion or exon 21 L858R) were randomized 1:1 to G 250 mg PO QD or GCP (G 250mg PO QD combined with carboplatin AUC 5 + pemetrexed 500mg/m2, every 3 weeks). The primary endpoints consisting of PFS, PFS2, and OS were sequentially analyzed according to a preplanned gate-keeping method. Secondary endpoints included objective response rate, safety, and quality of life.

      4c3880bb027f159e801041b1021e88e8 Result

      In Sep 2017, a preplanned required number of events of PFS2 was observed. The ITT population included 344 patients with baseline characteristics fairly well balanced between the arms. Although GCP demonstrated significantly better PFS compared to G, there was no difference in PFS2 between the arms as below. Additional OS analysis (G:101 events vs GCP:83 events) revealed that median survival time of GCP was much longer than that of G (52.2 months vs 38.8 months, HR: 0.695, p=0.013).

      8eea62084ca7e541d918e823422bd82e Conclusion

      NEJ009 was the first phase III study which evaluated the efficacy of a combination of EGFR-TKI and platinum doublet chemotherapy in untreated advanced NSCLC patients with EGFR mutations. Although GCP regimen failed to demonstrate its superiority in PFS2, it may increase long survivors.

      ITT Population GCP (N=169) G (N=172)
      Median (months) Median (months) HR
      PFS 20.9 11.2 0.493
      [95%CI: 18.0, 24.2] [95%CI: 9.0, 13.4] [95%CI: 0.390, 0.623]
      P<0.001
      PFS2 20.9 21.1 0.891
      [95%CI: 18.0, 24.2] [95%CI: 17.9, 24.9] [95%CI: 0.708, 1.122]
      P=0.806
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      P1.01-33 - Randomized Phase 2 Study Comparing CBDCA+PTX+BEV and CDDP+PEM+BEV in Treatment-Naïve Advanced Non-Sq NSCLC (CLEAR study) (ID 12448)

      16:45 - 18:00  |  Author(s): Akira Inoue

      • Abstract
      • Slides

      Background

      Bevacizumab (BEV) combined with platinum-based chemotherapy is a standard treatment for advanced non-squamous non-small-cell lung cancer (non-Sq NSCLC). Cisplatin (CDDP) + pemetrexed (PEM) is suggested as the most promising chemotherapy regimen combined with BEV. However, no study has been conducted to evaluate the efficacy and safety of CDDP+PEM+BEV compared with carboplatin (CBDCA) + paclitaxel (PTX) + BEV for advanced non-Sq NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Treatment-naïve patients with advanced or recurrent EGFR/ALK-negative non-Sq NSCLC from 55 sites across Japan were randomly assigned in a 2:1 ratio to either CDDP+PEM+BEV (4 cycles of CDDP [75 mg/m2] + PEM [500 mg/m2] + BEV [15 mg/kg] q3wk, followed by maintenance PEM + BEV q3wk until progression) or CBDCA+PTX+BEV (4 cycles of CBDCA [AUC 6] + PTX [200 mg/m2] + BEV q3wk, followed by maintenance BEV q3wk until progression). The primary endpoint was progression-free survival (PFS) by central review. The secondary endpoints were PFS by investigators, overall survival (OS), overall response rate (ORR) and safety profile. The target numbers of patients and events were determined to be 210 and 170, respectively, to observe a point estimate of HR for PFS (CDDP+PEM+BEV/CBDCA+PTX+BEV) <0.83 with a high probability (80%) when the true HR was 0.72.

      4c3880bb027f159e801041b1021e88e8 Result

      Between May 2014 and May 2016, 199 patients were randomly assigned to receive CDDP+PEM+BEV (N=132) or CBDCA+PTX+BEV (N=67). The median follow-up duration was 20.6 months. PFS events occurred in 171 patients. The HR for PFS by central review (CDDP+PEM+BEV/CBDCA+PTX+BEV) was 0.825 (95% CI 0.600-1.134, median PFS, 7.6 vs 7.0 months). The median PFS by investigators was longer with CDDP+PEM+BEV than with CBDCA+PTX+BEV (HR 0.634, 95% CI 0.464-0.867, median PFS, 7.4 vs 6.8 months). The median OS was 24.5 months for CDDP+PEM+BEV and 23.6 months for CBDCA+PTX+BEV (HR 0.955, 95% CI 0.620-1.470). The ORR was 57% for CDDP+PEM+BEV and 55% for CBDCA+PTX+BEV. The most common ≥G3 adverse events in both arms (CDDP+PEM+BEV/CBDCA+PTX+BEV) were neutropenia (24%/64%), hyponatraemia (11%/9%) and hypertension (30%/23%).

      8eea62084ca7e541d918e823422bd82e Conclusion

      CDDP+PEM is the most effective chemotherapy regimen combined with BEV for advanced non-Sq NSCLC.

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