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Guojun Zhang



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    EP1.14 - Targeted Therapy (ID 204)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.14-03 - Driver Genes as Predictive Indicators of Brain Metastasis in Patients with Advanced NSCLC: EGFR and ALK as Well as RET Gene Mutations (Now Available) (ID 2124)

      08:00 - 18:00  |  Author(s): Guojun Zhang

      • Abstract
      • Slides

      Background

      Brain metastasis is a cause of disease progression and death in lung cancer patients, and is also one of the most common metastatic sites of lung cancer. Non-small lung cancer (NSCLC) accounts for about 80% of all lung cancer patients, and adenocarcinoma has become the main subtype of NSCLC in recent years. A retrospective analysis verified the role of gene mutations in brain metastasis in patients with non-small lung cancer (NSCLC).

      Method

      The clinicopathological data of 552 patients who received driver genes detection for lung cancer in the Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital from January 2015 to June 2017 were collected; NGS was used for gene detection. The driving genes for detection were EGFR, ALK, KRAS, ROS-1, BRAF, ERBB2, RET and c-MET, which were eight lung cancer driving genes recommended in NCCN guidelines. All the tests were carried out in the Center of Molecular Pathology in the Affiliated Tumor Hospital of Zhengzhou University.

      Result

      Of the 552 patients with advanced NSCLC, 153 (27.7%) had brain metastases. Univariate analysis showed that age (P = 0.008), gender (P = 0.016), smoking history (P = 0.010), lymph node metastasis (P = 0.003), and three driver genes: positive EGFR mutation (P = 0.001), positive ALK gene fusion (P = 0.021) and positive RET gene fusion (P = 0.003) were factors influencing the incidence of brain metastasis. Logistic multivariate regression analysis revealed that only positive EGFR mutation (P = 0.012), positive ALK gene fusion (P = 0.015), positive RET gene fusion (P = 0.003), pathological type (P = 0.009), lymph node N2–3 metastasis (P = 0.000) and a younger age (P = 0.000) were independent risk factors for brain metastasis. In addition, a ROC curve was plotted with the above factors with AUC=0.705 (P=0.000).

      Conclusion

      EGFR mutation, ALK gene fusion and RET gene fusion in advanced NSCLC patients play roles in brain metastasis as positive driver genes.

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    OA02 - A New Vision of Targets and Strategies (ID 120)

    • Event: WCLC 2019
    • Type: Oral Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
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      OA02.03 - The Third Generation EGFR Inhibitor (EGFR-TKI) HS-10296 in Advanced NSCLC Patients with Resistance to First Generation EGFR-TKI (Now Available) (ID 766)

      10:30 - 12:00  |  Author(s): Guojun Zhang

      • Abstract
      • Presentation
      • Slides

      Background

      HS-10296 is an oral, potent, high selective third generation EGFR tyrosine-kinase inhibitor (EGFR-TKI) for sensitizing mutations, and the EGFR Thr790Met (T790M) resistance mutation which has been demonstrated by phase I study. This phase II, open-label, multicenter single-arm study was designed to confirm the efficacy and safety of HS-10296 in a large population of non-small-cell lung cancer (NSCLC) patients with EGFR T790M mutation, who had progressed after first generation EGFR-TKI treatment.

      Method

      Patients aged at least 18 years with centrally confirmed EGFR T790M-positive mutations, locally advanced or metastatic (stage IIIB/IV) NSCLC after first generation EGFR-TKI treatment received HS-10296 110 mg orally once daily until disease progression, or intolerable toxicity, or patient withdrawal. Patients with asymptomatic, stable brain metastases not requiring steroids were allowed to enroll. The primary endpoint was the objective response rate (ORR) by independent central review using Response Evaluation Criteria in Solid Tumors, version 1.1 every 6 weeks. Response endpoints (ORR and disease control rate [DCR]) were assessed in response analysis set. Secondary end points including progression-free survival (PFS), duration of response (DoR), depth of response (DepOR), overall survival (OS) and safety were evaluated in full analysis set. The final data cutoff was on Jan 5, 2019. The study is still ongoing.

      Result

      Totally, 244 patients (median age 60.8) entered study in 36 sites in mainland China (189 patients) and Taiwan (55 patients) between May 16, 2018 to Oct 23, 2018. 2 patients were excluded from the evaluable for response analysis set (n=242) due to absence of measurable disease at baseline by independent central review. At data cutoff, 182 (74.6%) patients remained on treatment. The median duration of follow-up was 4.7 months. 160 of 242 patients achieved confirmed partial responses by independent central review. The ORR was 66.1% (95% CI: 59.8-72.1). The DCR was 93.4% (95% CI: 89.5-96.2). The most common adverse reactions (≥ 10%) were blood creatine phosphokinase increased (43 [17.6%]), aspartate aminotransferase increased (29 [11.9%]), pruritus (28 [11.5%]), rash (28 [11.5%]) and alanine aminotransferase increased (26 [10.7%]). The most common all-causality grade 3 and 4 adverse events were blood creatine phosphokinase increased (14 [5.7%]) and hyponatraemia (4 [1.6%]). Serious adverse events were reported in 30 (12.3%) patients, of which 19 (7.8%) were investigator assessed as possibly treatment-related to HS-10296. Three deaths were due to adverse events; one was related to cardiopulmonary failure, other two events occurred after disease progression. There was no interstitial lung disease during study treatment.

      Conclusion

      HS-10296 has demonstrated good clinical benefit with minimal toxicity in patients with EGFR T790M-positive NSCLC patients who have progressed after first generation EGFR-TKI treatment. The Phase III study has already launched comparing HS-10296 with gefinitib in advanced NSCLC patients with EGFR sensitizing mutations. (The study was sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.; ClinicalTrials.gov number, NCT02981108)

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