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Zhendong Chen



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    MA14 - The Adequate MTarget Is Still the Issue (ID 140)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
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      MA14.05 - A Randomized Phase III Trial of Fruquintinib Versus Placebo in Patients with Advanced Non-Small Cell Lung Cancer (FALUCA) (Now Available) (ID 1490)

      15:45 - 17:15  |  Author(s): Zhendong Chen

      • Abstract
      • Presentation
      • Slides

      Background

      Fruquintinib, an orally active kinase inhibitor that selectively targets vascular endothelial growth factor (VEGF) receptor, demonstrated significant benefit in progression-free survival and disease control in a randomized Phase II study in patients with non-small-cell lung cancer (NSCLC) who had failed two lines of chemotherapy. This Phase III FALUCA trial is a randomized, double-blind, placebo-controlled, multicenter trial designed to confirm the efficacy in the same patient population (NCT02691299).

      Method

      From December 2015 to February 2018, 45 clinical centers across China participated in the trial. A total of 730 patients aged 18-75 with advanced NSCLC who had failed two lines of chemotherapy were screened and 527 who met the eligibility criteria were enrolled into the study. Patients were stratified based on epidermal growth factor receptor mutation status and prior use of VEGF inhibitor therapy, and were randomized in a 2:1 ratio to receive fruquintinib (n=354) or placebo (n=173) once daily in a 3 weeks on/1 week off 4-week cycle. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response. The final data cutoff was on September 21, 2018.

      Result

      Median OS was 8.94 months for fruquintinib and 10.38 months for placebo (hazard ratio, 1.02; 95% CI, 0.816 to 1.283; p=0.841). Median PFS was 3.68 months for fruquintinib comparing to 0.99 months for placebo, respectively (hazard ratio, 0.34; 95%CI, 0.279 to 0.425; p<0.001). The ORR and DCR were 13.8% and 66.7% for fruquintinib, compared with 0.6% and 24.9% for placebo (both p<0.001), respectively. The most frequent treatment-emergent adverse events with fruquintinib (≥grade 3) were hypertension (20.7%), hand-foot syndrome (11.0%), and proteinuria (1.4%). A sensitivity analysis revealed that median OS was significantly prolonged with fruquintinib compared with placebo in patients who received no subsequent systemic anti-tumor therapies (7.00 months versus 5.06 months ; hazard ratio, 0.64; 95%CI, 0.453 to 0.903; p=0.010).

      Conclusion

      The FALUCA trial failed to meet the primary end point of OS while confirming significant benefit in secondary end points including PFS, ORR and DCR. The safety profile of fruquintinib in this patient population was acceptable and consistent with that identified in the Phase II study. A post-hoc sensitivity analysis revealed that the anti-tumor therapies that patients received post disease progression probably contributed to the failure of this study on the primary end point.

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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
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-03 - Efficacy and Safety of Biosimilar QL1101 Compared with Avastin in Patients with Non-Squamous Non-Small Cell Lung Cancer (ID 738)

      09:45 - 18:00  |  Author(s): Zhendong Chen

      • Abstract

      Background

      QL1101 is a biosimilar molecule of bevacizumab (BEV, Avastin®), a monoclonal antibody (mAb) that binds and inhibits vascular endothelial growth factor (VEGF).The main purpose of the study is to evaluate whether the effectiveness of QL1101 is bioequivalent to that of Avastin®, and the secondary purpose is to evaluate the bioequivalence on safety and immunogenicity between QL1101 and Avastin®.

      Method

      Total 512 patients with locally metastatic or recurrent non-squamous cell non-small cell lung cancer were planned to recruit in the study (NCT03169335). The patients were divided into QL1101 (test group) or Avastin® (control group) at 1:1 ratio in combination respectively with paclitaxel/carboplatin (paclitaxel 175mg/m2, carboplatin AUC=5). QL1101 or Avastin was given every 3 weeks as one treatment cycle for 6 cycles with the same dose of 15mg/kg per time, then followed by QL1101 single-drug maintenance treatment. The primary endpoint was the best objective response rate (ORR) at week 18 as evaluated by the blind independent imaging review committee, and the secondary endpoints include DOR, PFS and OS.

      Result

      A total of 675 subjects were screened and 532 were finally enrolled and treated including 266 in the trial group and 266 in the control group. At week 18, the ORR of the QL1101 group and Avastin group were 52.26% (CR: 0, PR: 139) and 56.02% (1 cases CR, 148 PR), respectively, and risk ratio (RR) value and 90% CI was 0.933 (0.818-1.064), which met the pre-specified equivalence margins (0.75-1.33). The mDOR in QL1101 group and Avastin group was 5.88 and 6.93 month (P=0.5044respectively, and mPFS were 7.88 and 8.34 months (P=0.2760) accordingly, the 12-month OS in the two groups was 69.18% and 75.10% respectively. The incidence of CTCAE grade 3 adverse events was 31.20 % in QL1101 group and 24.06 % in Avastin group, respectively (P = 0.0808). The immunogenicity (ADA and Nab tested) of the two groups was similar.

      Conclusion

      QL1101 and Avastin are equivalent in clinical efficacy, and the safety profile (including immunogenicity) is quite similar in patients with non-squamous cell non-small cell lung cancer. There are no unexpected serious adverse reactions were found during the study.