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Akimasa Sekine



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    OA07 - Precision Medicine Involves Biology and Patients (ID 132)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      OA07.03 - Clinical Outcome of Non-Small Cell Lung Cancer with EGFR/HER2 Exon 20 Insertions Identified in the LC-SCRUM-Japan (Now Available) (ID 629)

      11:00 - 12:30  |  Author(s): Akimasa Sekine

      • Abstract
      • Presentation
      • Slides

      Background

      In-frame insertions in exon 20 (Ex20ins) of EGFR/HER2 occur in 2-5 % of non-small cell lung cancer (NSCLC). There is no approved targeted therapy for patients with these mutations. Historical control data would be valuable for the development of novel targeted therapies for these rare cancers.

      Method

      A nationwide genome screening project in Japan (LC-SCRUM-Japan) has been established for the development of molecular-targeted therapies for lung cancers. In this project, 161 cancer-related genes have been analyzed by a next-generation sequencing (NGS) system, Oncomine™ Comprehensive Assay. The therapeutic efficacy and survival of the patients with non-squamous (non-sq) NSCLC harboring EGFR/HER2 Ex20ins were evaluated using a large-scale clinico-genomic database in the LC-SCRUM-Japan.

      Result

      A total of 3441 advanced non-sq NSCLC patients were successfully analyzed from 2015 to 2018. EGFR Ex20ins were detected in 73 patients (2%; M766_A767insASV/A767_S768insSVD/H773_V774insH/D770_N771insNPH/N771_P772insPH/others=22/17/5/4/4/21) and HER2 Ex20ins were detected in 128 patients (4%; A775_G776insYVMA/G776delinsVC/P780_Y781insGSP/others=95/16/10/7). The median age of the patients was 62 (range, 33-90) years. Eighty-one patients (40%) were male and 114 (57%) were never smoker. Two-hundred patients (99%) were diagnosed as adenocarcinoma and 1 as adenosquamous-cell carcinoma. Based on our database, the median overall survivals in patients with EGFR Ex20ins were 22.4 (95%CI, 15.3-36.8) months, and those with HER2 Ex20ins were 18.8 (13.6-30.3) months. In the patients with EGFR/HER2 Ex20ins, the objective response rate (ORR) and median progression-free survivals (mPFS) of 1st-line platinum-containing chemotherapies were 32% and 6.0 (5.7-7.0) months, respectively. The ORR and mPFS of docetaxel with or without ramucirumab were 26% and 5.1 (3.8-5.9) months, respectively. The ORR and mPFS of PD-1 inhibitor were 0% and 2.0 (1.6-2.6) months, respectively. No significant difference in the therapeutic efficacy of these drugs was observed between the patients with EGFR Ex20ins and HER2 Ex20ins. In 19 patients with EGFR Ex20ins treated with 1st/2nd generation EGFR-TKIs, the ORR was 5% (a M766_A767insASV-positive tumor responded to afatinib) and the mPFS was 2.1 (1.3-4.2) months.

      Conclusion

      The patients with EGFR/HER2 Ex20ins-positive NSCLC showed poor responses to PD-1 inhibitors and 1st/2nd generation EGFR-TKIs. These historical data are highly informative in evaluating the efficacy of novel targeted therapies for EGFR/HER2 Ex20ins-positive NSCLC.

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-08 - Randomized Phase II Trial of CBDCA+nab-PTX vs CDDP+GEM in Patients with Chemo-Naïve Squamous Cell Lung Cancer: NJLCG1302 (Now Available) (ID 971)

      09:45 - 18:00  |  Author(s): Akimasa Sekine

      • Abstract
      • Slides

      Background

      The subset analysis of CA031 trial showed a significant improvement of overall response rate (ORR) for carboplatin (CBDCA) plus weekly nab-PTX versus CBDCA plus PTX in patients (pts) with squamous cell histology (41% vs 24%). We conducted a phase II study comparing CBDCA plus weekly nab-PTX (CnP) to cisplatin plus gemcitabine (CG), one of the standard regimens in pts with squamous cell lung cancer (SCC).

      Method

      Chemo-naïve stage IIIB/IV or postoperative recurrent SCC pts were randomly assigned to receive either cisplatin (80 mg/m2) on day 1 plus gemcitabine (1000 mg/m2) on days 1, 8 every 3 weeks or CBDCA (area under the curve [AUC] 6 mg/ml/min) on day 1 plus nab-PTX (75 mg/m2) on days 1, 8, 15 every 3 weeks. The primary endpoint was ORR. Secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and toxicity. Assuming that an ORR of 40% in eligible pts indicates potential usefulness and ORR of 20% is the lower limit of interest, the estimated accrual was 32 pts in each arm. Allowing for dropouts, the accrual goal was determined to be 35 pts in each arm (alpha, 0.05; beta, 0.20).Thisstudy was planned to enroll 70 pts in total.

      Result

      Between June 2013 and October 2018, 71 pts were enrolled and assigned to CG arm (n=35) and CnP arm (n=36). The median follow-up time was 10.8months. At data cutoff (March 31, 2019), ORR was 43% (95% confidence interval [CI]: 27.3-58.5) in CG arm and 47% (95%CI: 31.7-62.7) in CnP arm. DCR was 77% in CG arm and 80% in CnP arm. Median PFS was 4.6 months in CG arm and 4.1months in CnP arm. Median OS was 15.2months in CG arm and 10.2months in CnP arm. Of the grade 3 or higher adverse events, anemia was more common in CnP arm (CG, 17% and CnP, 53%). There was one treatment-related death in CG arm and no treatment-related death in CnP arm.

      Conclusion

      In this study, CBDCA plus weekly nab-PTX was likely to be equivalent to cisplatin plus gemcitabine despite carboplatin-based regimen. CBDCA plus weekly nab-PTX could be a promising regimen for SCC.

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