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Xingya Li



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    FP14 - Targeted Therapy - Clinically Focused (ID 252)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      FP14.11 - Icotinib versus Chemotherapy as Adjuvant Treatment for Stage II–IIIA EGFR-Mutant NSCLC (EVIDENCE): A Randomized, Open-Label, Phase 3 Study (ID 3605)

      00:00 - 00:00  |  Author(s): Xingya Li

      • Abstract

      Introduction

      Recent studies have shown significant benefits of EGFR tyrosine kinase inhibitors in the adjuvant setting for patients with EGFR-mutant stage IB–IIIA resected NSCLC. This study aimed to compare the efficacy and safety of icotinib with standard chemotherapy in adjuvant setting in patients with EGFR mutant stage II-IIIA NSCLC.

      Methods

      In this randomized, open-label, phase 3 study, eligible patients aged 18-70 years who had completely resected (R0), stage II-IIIA EGFR-mutant NSCLC (in-frame deletion in exon 19 or Leu858Arg point mutation in exon 21) were randomly assigned, in a 1:1 ratio, to receive either adjuvant icotinib (125 mg thrice daily administered orally for 2 years) or four-cycle chemotherapy (cisplatin plus vinorelbine, or cisplatin plus pemetrexed for non-squamous carcinoma). Patients were stratified by clinical stage (II vs IIIA), EGFR mutation type (exon 19 vs 21), and resection methods (lobectomy vs pneumonectomy). The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety.

      Results

      A total of 365 patients were screened, and 322 patients (161 for each arm) were enrolled from 29 centers across China between June 2015 and July 2019. Thirty-nine patients had major protocol violations and were excluded, leaving 283 patients in full analysis set (151 in icotinib arm and 132 in chemotherapy arm, respectively). 53% and 47% of patients had an EGFR mutation of 19 Del and 21 L858R, respectively. At the data cutoff (March 31, 2020) for the pre-specified interim analysis, 98 out of 196 (50%) events were recorded with a median follow-up of 24.9 months (95% CI, 22.1 to 28.8). In full analysis population, the median DFS (mDFS) was 47.0 months (95% CI, 36.44 to not reached) in the icotinib group and 22.1 months (95% CI, 16.8 to 30.4) in the chemotherapy group (stratified hazard ratio=0.36; 95% CI, 0.24 to 0.55; P < 0.0001). Analyses of DFS based on stratification criteria and vital demographic and prognostic factors showed consistent benefits of icotinib treatment across subgroups. The 3-year DFS was 63.9% in the icotinib group and 32.5% in the chemotherapy group. It is immature to perform OS analysis with14 (9.3%) patients in the icotinib group and 14 (10.6%) patients in the chemotherapy group died, respectively. Adverse events of grade 3 or 4 were observed in 10.9% of the patients in the icotinib group and 61.2% in the chemotherapy group. Treatment-related serious adverse events occurred in 2 (1.3%) patients in the icotinib group and 19 (13.7%) patients in the chemotherapy group. No interstitial pneumonia or treatment-related death was observed in each group.

      Conclusion

      Adjuvant icotinib significantly improved DFS in patients with EGFR mutant stage II-IIIA NSCLC compared with standard chemotherapy and demonstrated a better tolerability profile. Icotinib can provide a new treatment option for stage II-IIIA NSCLC patients with activating EGFR mutation.

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    JICC01 - Joint IASLC-CAALC-CSCO Session: The Truth and Myth of Oral Anti-VEGFR Inhibitors for Advance NSCLC (ID 276)

    • Event: WCLC 2020
    • Type: Workshop
    • Track: N.A.
    • Presentations: 1
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      JICC01.11 - Icotinib versus Chemotherapy as Adjuvant Treatment for Stage II–IIIA EGFR-Mutant NSCLC (EVIDENCE): A Randomized, Open-Label, Phase 3 Study (ID 4275)

      07:00 - 09:00  |  Author(s): Xingya Li

      • Abstract

      Introduction
      Recent studies have shown significant benefits of EGFR tyrosine kinase inhibitors in the adjuvant setting for patients with EGFR-mutant stage IB–IIIA resected NSCLC. This study aimed to compare the efficacy and safety of icotinib with standard chemotherapy in adjuvant setting in patients with EGFR mutant stage II-IIIA NSCLC. Methods
      In this randomized, open-label, phase 3 study, eligible patients aged 18-70 years who had completely resected (R0), stage II-IIIA EGFR-mutant NSCLC (in-frame deletion in exon 19 or Leu858Arg point mutation in exon 21) were randomly assigned, in a 1:1 ratio, to receive either adjuvant icotinib (125 mg thrice daily administered orally for 2 years) or four-cycle chemotherapy (cisplatin plus vinorelbine, or cisplatin plus pemetrexed for non-squamous carcinoma). Patients were stratified by clinical stage (II vs IIIA), EGFR mutation type (exon 19 vs 21), and resection methods (lobectomy vs pneumonectomy). The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety. Results
      A total of 365 patients were screened, and 322 patients (161 for each arm) were enrolled from 29 centers across China between June 2015 and July 2019. Thirty-nine patients had major protocol violations and were excluded, leaving 283 patients in full analysis set (151 in icotinib arm and 132 in chemotherapy arm, respectively). 53% and 47% of patients had an EGFR mutation of 19 Del and 21 L858R, respectively. At the data cutoff (March 31, 2020) for the pre-specified interim analysis, 98 out of 196 (50%) events were recorded with a median follow-up of 24.9 months (95% CI, 22.1 to 28.8). In full analysis population, the median DFS (mDFS) was 47.0 months (95% CI, 36.44 to not reached) in the icotinib group and 22.1 months (95% CI, 16.8 to 30.4) in the chemotherapy group (stratified hazard ratio=0.36; 95% CI, 0.24 to 0.55; P < 0.0001). Analyses of DFS based on stratification criteria and vital demographic and prognostic factors showed consistent benefits of icotinib treatment across subgroups. The 3-year DFS was 63.9% in the icotinib group and 32.5% in the chemotherapy group. It is immature to perform OS analysis with14 (9.3%) patients in the icotinib group and 14 (10.6%) patients in the chemotherapy group died, respectively. Adverse events of grade 3 or 4 were observed in 10.9% of the patients in the icotinib group and 61.2% in the chemotherapy group. Treatment-related serious adverse events occurred in 2 (1.3%) patients in the icotinib group and 19 (13.7%) patients in the chemotherapy group. No interstitial pneumonia or treatment-related death was observed in each group. Conclusion
      Adjuvant icotinib significantly improved DFS in patients with EGFR mutant stage II-IIIA NSCLC compared with standard chemotherapy and demonstrated a better tolerability profile. Icotinib can provide a new treatment option for stage II-IIIA NSCLC patients with activating EGFR mutation.

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    P77 - Immunotherapy (Phase II/III Trials) - Combining Different Immunotherapeutic Approaches (ID 254)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Immunotherapy (Phase II/III Trials)
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P77.03 - A Phase II Study of KN046 (Bispecific Anti-PD-L1/CTLA-4) in Patients (pts) with Metastatic Non-Small Cell Lung Cancer (NSCLC) (ID 1665)

      00:00 - 00:00  |  Author(s): Xingya Li

      • Abstract

      Introduction

      KN046 is a novel bispecific antibody that blocks PD-L1 interaction with PD1 and CTLA-4 interaction with CD80/CD86. This multiple-cohort, single-arm phase II study evaluates preliminary safety and efficacy of KN046 in subjects with metastatic non-small cell lung cancer (NSCLC).

      Methods

      Eligible patients (pts) were advanced NSCLC without EGFR mutation or ALK fusions, progressed on 1st line platinum-based chemotherapy but not treated with any PD-(L)1 immune checkpoint inhibitor. All pts were given KN046 3 mg/kg (Cohort A) or 5 mg/kg (Cohort B) Q2W IV up to disease progression, intolerable toxicity, etc. Efficacy evaluation was performed by investigators per RECIST 1.1 every 8 weeks and safety and tolerability assessed per NCI-CTCAE v5.0.

      Results

      As of the July 27, 2020, 30 pts enrolled in Cohort A and 33 in Cohort B. Median age 59 years, male/female 51/12, PS 0/1 9/54, squamous NSCLC/Non-squamous NSCLC 23/40. ≥ Grade 3 treatment related treatment emergent adverse events (TRAEs) were seen in 21 (33.3%) pts, treatment related severe adverse events (SAE) 16 (25.4%) pts, immune related adverse events (irAEs) 34 (54.0%) pts, ≥ Grade 3 irAEs 11 (17.5%) pts. Common (≥ 10%) TRAEs were infusion related reaction (16, 25.4%), anemia (14, 22.2%), rash (13, 20.6%), hyperglycemia (12, 19.0%), abnormal hepatic function (10, 15.9%), hypothyroidism (10, 15.9%), alanine aminotransferase increased (8, 12.7%), asthenia (8, 12.7%), aspartate aminotransferase increased (7, 11.1%) and pruritus (7, 11.1%). Safety profile was comparable between two cohorts.

      As of cutoff date, 24 (37.5%) pts remained on the study treatment, and 39 (60.9%) pts discontinued treatment due to disease progression (n=27), AE (n=7), poor patient compliance (n=4) and one death. Median duration of drug exposure was 14 weeks (two to 56 weeks). ORR and DCR were 10.7% and 82.1%, 15.6% and 62.5% in cohort A and cohort B, respectively. Median PFS were 3.7 (2.9, 7.3), 3, 6 and 9-month PFS rate (95% CI) were 64.1% (49.4, 75.5), 36.6% (23.0, 50.4) and 34.2% (20.9, 47.9), 3, 6 and 9-month OS rate (95% CI) were 91.4% (80.5, 96.3), 86.9% (74.2, 93.6) and 81.0% (65.8, 89.9). In squamous NSCLC, median PFS was 7.3 (3.7, NE), 3, 6 and 9-month PFS rate (95% CI) was 80.0% (54.9, 92.0), 55.9% (27.0, 77.2) and 46.6% (19.0, 70.3), 3, 6 and 9-month OS rate (95% CI) were 100.0% (100.0,100.0), 88.2% (60.2, 96.9) and 88.2% (60.2, 96.9).

      Conclusion

      The bispecific antibody, KN046 was well tolerated and effective as 2nd line treatment of advanced NSCLC. KN046 showed promising PFS and OS benefit in squamous NSCLC.