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Jun Sato



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    MA11 - Immunotherapy in Special Populations and Predictive Markers (ID 135)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Immuno-oncology
    • Presentations: 1
    • Now Available
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      MA11.07 - Efficacy of Immune-Checkpoint Inhibitors and EGFR-TKIs in NSCLC Patients with High PD-L1 Expression (Now Available) (ID 667)

      14:00 - 15:30  |  Author(s): Jun Sato

      • Abstract
      • Presentation
      • Slides

      Background

      Recently, several studies have demonstrated that patients with non-small cell lung carcinoma (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations show poor clinical outcomes in response to treatment with anti-programmed cell death-1 (PD-1) inhibitors. Conversely, EGFR tyrosine kinase inhibitors (EGFR-TKIs) are not effective in NSCLC showing high programmed death ligand 1 (PD-L1) expression levels. In this study, we retrospectively investigated the relationship between high PD-L1 expression and the efficacy of PD-1 inhibitors and EGFR-TKIs in patients with NSCLC.

      Method

      The subjects of this study were patients with NSCLC who had received treatment with PD-1 inhibitors at the National Cancer Center Hospital between March 2017 and December 2018. The PD-L1 expression in the tumor cells was divided into two groups based on the tumor proportion score (TPS): <50% (low) and ≥50% (high).

      Result

      Of the 414 patients treated with PD-1 inhibitors, the 263 patients in whom the PD-L1 expression levels could be evaluated were considered as being eligible for inclusion in this study. Among the 153 patients with high PD-L1 expression, we assessed the efficacy of PD-1 inhibitors according to the EGFR mutation status. The objective response rate (ORR) was 29.4% (95% confidence interval [CI], 1.3 to 53.1) in the EGFR-mutated patients and 43.4% (95% CI, 35.4 to 51.8) in the EGFR wild-type patients. The median progression-free survival (PFS) was 5.3 months (95% CI, 1.3 to 12.4) in the EGFR-mutated patients and 8.3 months (95% CI, 6.0 to 11.7) in the EGFR wild-type patients (hazard Ratio [HR] = 0.62; 95% CI, 0.62 to 1.14). A total of 33 patients received EGFR-TKI therapy. We assessed the efficacy of EGFR-TKIs according to the PD-L1 expression level. The ORR was 50.0% (95% CI, 28.0 to 72.0) in the high PD-L1 expression group and 52.9% (95% CI, 31.0 to 73.8) in the low PD-L1 expression group. The median PFS was 18.8 months (95% CI, 2.8 to 35.7) in the high PD-L1 expression group and 12.7 months (95% CI, 7.2 to 20.9) in the low PD-L1 expression group (HR = 0.83; 95% CI, 0.38 to 1.81).

      PD-L1 High

      EGFR+

      PD-L1 High

      EGFR−

      PD-L1 Low

      EGFR+

      PD-L1 Low

      EGFR−

      Total N

      17

      136

      18

      92

      Median age, years (range)

      62 (47–85)

      62 (33–87)

      64.5 (37–83)

      62 (33–83)

      Sex (n)

      Female

      Male

      7

      10

      36

      100

      15

      3

      25

      67

      ECOG PS (n)

      0, 1

      2

      14

      3

      125

      11

      16

      2

      81

      11

      Smoking history (n)

      Never-smoker

      Smoker

      7

      10

      21

      115

      12

      6

      13

      79

      EGFR mutation status (n)

      Ex 19 del

      L858R

      Others

      7

      6

      4

      13

      2

      3

      ICI agent used (n)

      Pembrolizumab

      Nivolumab

      11

      6

      105

      31

      4

      14

      21

      71

      Line of ICI therapy (n)

      First-line

      Second-line

      Third-line or more

      2

      3

      12

      85

      42

      9

      5

      64

      23

      0

      2

      16

      Efficasy

      ORR (%)

      PD-1 inhibitors

      EGFR-TKIs

      PFS (months)

      PD-1 inhibitors

      EGFR-TKIs

      29.4

      50.0

      5.3

      18.8

      43.4

      8.3

      0

      52.9

      1.6

      12.7

      16.3

      3.8

      Conclusion

      Even in a population of NSCLC patients showing high PD-L1 expression, the efficacy of PD-1 inhibitors tended to be lower in the EGFR-mutated patients as compared to the EGFR wild-type patients. In regard to EGFR-mutated patients with a PD-L1 TPS of ≥50%, our findings suggested that high PD-L1 expression might not predict a poor efficacy of EGFR-TKIs.

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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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      P1.01-102 - Actionable Gene Aberration and the Response of Matched Therapy Among Patients with Non-Small-Cell Lung Carcinoma (Now Available) (ID 1177)

      09:45 - 18:00  |  Author(s): Jun Sato

      • Abstract
      • Slides

      Background

      Tumor genotyping using multiplex gene panel is now standard for precision medicine in non-small-cell lung carcinoma (NSCLC). We sought to assess the prevalence of actionable genomic alterations among NSCLC patients using our next-generation sequencing panel (NCC Oncopanel) and the response of matched therapy.

      Method

      This is a post-hoc analysis of prospective study in which patients with advanced solid cancer were prospectively enrolled to undergo the comprehensive genomic profiling panel (NCC Oncopanel) conducted between July 2013 and March 2018 in National Cancer Center Hospital. The NCC Oncopanel assay, a multiplexed next-generation sequencing (NGS) assay of 114 cancer-associated genes, was performed in a CLIA-compliant laboratory in National Cancer Center. Subjects were primarily patients without any known actionable alteration such as EGFR or ALK. Patients with NSCLC were extracted into this analysis. Clinical data and treatment outcomes were retrospectively collected.

      Result

      In total, 100 patients were extracted. Sufficient tumor tissue for NGS analysis were available in 91 patients; median age was 57 (range 30‒77); 74 (81.3%) adenocarcinoma; 44 (48.4%) female; 42 (46.2%) never smoker. According to the OncoKB and CIViC database, and the Clinical Practice Guidelines for NGS in Cancer Diagnosis and Treatment issued by three major Japanese cancer-related societies, 85 patients (93.4%) had at least one potential pathogenic alteration. Actionable gene aberrations were identified in 49 (53.9%). Evidence levels were ranked as follows: 24 (26%) harbored level 1 aberrations (ALK, EGFR, ROS1, BRAF); 15 (16%) harbored level 2 (RET, DDR2, MET, ATM, BRCA2, CDK4, CTNNB1, EZH2, JAK2, NRAS, TSC1); 10 (11%) harbored level 3A (CDKN2A, ERBB2, HRAS, PTEN, SMARCA4, STK11). Matched therapy was administered into 29 (31.9%) leading to the objective response rate of 58.6% and the disease control rate of 79.3% with the median progression-free survival of 10.5 months (95%CI; 5.1‒15.8).

      Conclusion

      Multiplex gene panel is feasible and useful in screening candidates for matched therapy among NSCLC patients. NSCLC patients without any known actionable mutations should be considered to undergo comprehensive genomic profiling.

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