Virtual Library

 x 
My Library Virtual Library FAQ

Start Your Search

Y. Hu



Author of

  • +

    P1.07 - Immunology and Immunotherapy (ID 693)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Immunology and Immunotherapy
    • Presentations: 1
    • +

      P1.07-037 - Testing the Positive and Negative Immune Checkpoint on PBMCs of Patients from Initiatory to Terminative Treatment of Anti PD-1 Antibody (ID 10459)

      09:30 - 09:30  |  Author(s): Y. Hu

      • Abstract

      Background:
      Recent approaches to malignant tumor have turned to immunotherapy which shows outstanding clinical efficacy, especially the agents of programmed death 1(PD-1) pathway. In this study, we try to find the relationshi between the clinical benefit and the change of immune biomarkers in peripheral blood monocular cells(PBMCs) by continuous testing.

      Method:
      Nineteen patients diagnosed with medium and advanced cancer received nivolumab 3mg/kg or pembrolizumab 2mg/kg intravenously, combined with chemotherapy in some cases, every two or three weeks until the disease is progression or the treatment is suspended due to unacceptable toxicity. We performed flow cytometry analysis of peripheral blood samples to test negative immune checkpoint molecules: PD-1, CTLA-4, TIM-3, LAG-3, BTLA, 2B4, VISTA, CD160, CD107a, Ki-67 and positive molecules: OX40, GITR, ICOS, CD137. Blood was collected before, during and after treatment.

      Result:
      Between Dec 22, 2016 and Jun 14, 2017, we collected blood samples from 19 patients and evaluated them every two cycles by RECICST 1.1. The objective responses rate(ORR) was 3/19(15.8%). Progressive disease(PD) was observed in two of these patients after two cycles of treatment. The rate of grade 3-4 adverse events related to anti-PD-1 agents was 2/19(10.5%), including interstitial pneumonia. Immune biomarker analysis demonstrated that negative biomarkers including LAG-3(P=0.027), 2B4(P=0.049), VISTA(P=0.035), CD160(P=0.037), and the positive one ICOS(P=0.030) showed variation before and after treatment. After immunotherapy, such inhibited molecules as BTLA and CD160 obviously higher expressions than others. Additionally, the proportions of CD4+T, CD8+T and NK might have been effects to the response of immunotherapy.

      Conclusion:
      The clinical benefit after the treatment with anti-PD-1 agents might be related to the change of expressions of other immune checkpoints, which may suggest the next therapy when patients get progressed. The low expressions of LAG-3, 2B4, VISTA, CD160 and the high expression of ICOS may be a good signal of the response of immunotherapy. Our study is ongoing and we still need a large amount of sample analysis and in-depth profiling.

  • +

    P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Clinical Design, Statistics and Clinical Trials
    • Presentations: 1
    • +

      P2.04-003 - Phase II Trial of X-396 (Ensartinib) for Chinese Patients with ALK (+) Non–Small-Cell Lung Cancer Who Progressed on Crizotinib (ID 8849)

      09:30 - 09:30  |  Author(s): Y. Hu

      • Abstract

      Background:
      Crizotinib has been established as the standard first-line treatment for patients with ALK-rearranged non-small-cell lung cancer. However, despite its superiority to chemotherapy, resistance occurs within approximately 12 months. New ALK-inhibitors are needed to overcome the resistance to crizotinib and to increase drug penetration to CNS. X-396 (ensartinib) is a novel, potent ALK tyrosine kinase inhibitor (TKI). Its phase I/II study showed X-396 is well-tolerated with favorable anti-tumor activities in both ALK TKI-naïve and crizotinib-resistant NSCLC patients, as well as patients with CNS metastases. The recommended phase II dose (RP2D) was established at 225 mg, once daily.

      Method:
      A phase II, multi-center study is evaluating the efficacy and safety of single-agent X-396 in Chinese patients with ALK (+) non–small-cell lung cancer after progression on crizotinib. Eligible patients will have documentation of a positive ALK rearrangement and progression on crizotinib. X-396 225 mg is orally administered until disease progression or intolerable toxicity. The primary endpoint is RECIST 1.1 response rate. Secondary endpoints include PFS, duration of response, and safety. The sample size is calculated using the test for inequality method, assuming that X396 have an ORR of 50% in patients with ALK-positive NSCLC, 15% higher than that from existing second-line therapy. Therefore, up to 144 patients will be enrolled with a significance level and power of 5% and 90%, respectively. Recruitment will be started on September, 2017.

      Result:
      Section not applicable

      Conclusion:
      Section not applicable