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Xingsheng Hu



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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-37 - BPI-9016M, a Novel c-Met Inhibitor, in Pretreated Advanced Solid Tumor: Results from a First-In-Human, Phase 1, Dose-Escalation Study (ID 12317)

      16:45 - 18:00  |  Presenting Author(s): Xingsheng Hu

      • Abstract
      • Slides

      Background

      BPI-9016M (Betta Pharmaceuticals Co, Ltd, Hangzhou, China) is a potent targeted therapy that inhibits MET and Axl. This first-in-human study is to assess the safety, tolerability, and pharmacokinetics (PK) of BPI-9016M in patients with advanced solid tumor, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for the phase Ib/II study.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Eligible patients were enrolled into sequential dose-escalating cohorts from 100 mg to 1000 mg given orally once per day continually following the conventional 3+3 design. The primary endpoint was safety and tolerability. MTD was defined as the highest dose level resulting in <1 of 3 dose limiting toxicities (DLTs). Blood levels of BPI-9016M were evaluated after single and multiple administration (NCT02478866).

      4c3880bb027f159e801041b1021e88e8 Result

      Twenty patients were enrolled and treated in 6 of 7 predefined dose cohorts (100 mg n=4, 200 mg n=3, 300 mg n=3, 450 mg n=4, 600 mg n=3, 800 mg n=3), dose escalation stopped at 800 mg due to saturation. All had stage IV non-small cell lung cancer (NSCLC) progressed on previous systemic therapy (including previous EGFR TKI in 16 patients). BPI-9016M was well-tolerated in all dose cohorts without DLT. The incidence of overall and grade 3/4 TRAEs was 85% and 45%, respectively. Common TRAEs included elevated ALT (45%), constipation (30%), elevated bilirubin (25%), and oral paresthesia (25%). Tumor response was seen in 1 patients in the 800 mg dose cohort. Systemic exposure to BPI-9016M (maximum plasma concentration and AUC) increased with increasing dose. Mean time to maximum plasma concentration and half-life were 2 to 5.33 hours and 8.09 to 22.3 hours, respectively. Two metabolites (M1, M2-2) were detected.

      8eea62084ca7e541d918e823422bd82e Conclusion

      BPI-9016M was well tolerated in patients with advanced solid tumor. A phase Ib study is ongoing to investigate the safety and activity of BPI-9016M in patients with c-Met-dysregulated advanced NSCLC (NCT02929290).

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P1.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 944)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.12-03 - A Prospective Study of Apatinib in Advanced Small Cell Lung Cancer Patients Failed from Two or More Lines of Chemotherapy (ID 13140)

      16:45 - 18:00  |  Author(s): Xingsheng Hu

      • Abstract
      • Slides

      Background

      Small lung cancer (SCLC), a highly malignant neoplastic, chemoresponsive disease. For SCLC patients who with worsening status after second-line treatment, there is currently no affirmative and widely accepted chemotherapy regimen. Apatinib is a novel oral multi-target small-molecule TKI mainly targeting the intracellular ATP-binding domain of VEGFR-2, which has a significant effect of anti-angiogenesis to suppress the growth of tumors. This study evaluated the efficacy and safety of Apatinib in SCLC patients who failed from second- or further-line chemotherapy.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Data was collected from the files of patients treated with Apatinib 500mg qd who diagnosed with advanced SCLC and failed from second or more lines of chemotherapy. Efficacy assessed after one cycles (4 weeks), then every two cycles (8 weeks) once again. The primary endpoint was PFS and the tumor response was determined according to the RECIST 1.1. PFS were graphed by Kaplan-Meier curves of progression-free survival. AEs were also evaluated and toxicity grade was determined based on CTCAE 4.0.

      4c3880bb027f159e801041b1021e88e8 Result

      22 patients were enrolled from November 10, 2016 to April 18, 2018, the number of patients that can be evaluated is 19. One patients obtained partial response, and 15 obtained stable disease, representing a DCR of 84.11%. Median PFS was 140 days (95% confidence interval [CI] 94.84–185.16). Although only one patient showed PR, all the patients’ target lesions were reduced. A total of 46 AEs were reported during the trial, grade 3-4 AEs were hypertension (9.09%), leukopenia (4.55%) and proteinuria (4.55%) which most could be relieved by dose reduction. figure 1..jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      In conclusion, Apatinib has a certain therapeutic effect in patients with advanced SCLC (third- or further-line). To further investigate the role of Apatinib in advanced SCLC patients, large sample and additional clinical trials are needed.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P2.13 - Targeted Therapy (Not CME Accredited Session) (ID 962)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.13-30 - High-Dose Icotinib in Advanced Non-Small Cell Lung Cancer with EGFR 21 L858R Mutation: The Randomized, Open-Label INCREASE Study (ID 13184)

      16:45 - 18:00  |  Author(s): Xingsheng Hu

      • Abstract
      • Slides

      Background

      NSCLC patients with 21 L858R mutation are less responsive to EGFR TKI treatment. This study aims to determine if high-dose icotinib can improve tumor response and progression-free survival (PFS) in this patient population.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In this randomized, open-label, multicenter phase II trial (INCREASE), patients with treatment-naïve, EGFR-mutant (19 deletion or 21 L858R at 1:2 ratio) lung adenocarcinoma were enrolled. Patients with 21 L858R were randomized to receive either routine-dose (125mg tid, 21 L858R-RD) or high-dose icotinib (250mg tid, 21 L858R-HD), whereas patients with 19 del receive icotinib 125mg tid until progression. The primary endpoint is PFS.

      4c3880bb027f159e801041b1021e88e8 Result

      Between May 22, 2015 and November 15, 2017, 253 patients were enrolled (21 L858R-RD group, n=86; 21 L858R-HD group, n=90; 19 del group, n=77). Baseline characteristics were similar among groups with the exception of age. The median PFS (by IRC) were 9.20 months (95%CI 8.31, 10.74), 12.85 (10.09, 15.84), and 12.48 (9.23, 13.93) for 21 L858R-RD, 21 L858R-HD, and 19 del group, respectively, for modified intent-to-treat population (p=0.0848); and 8.84 months (8.21, 10.55), 12.62 (9.59, 14.26), and 12.22 (9.17, 13.60) for per-protocol set (p=0.0445). The ORR were 47.7%, 73.3%, and 75.3% for 21 L858R-RD, 21 L858R-HD, and 19 del group, respectively (p=0.0007). Patients in high-dose group experienced significantly higher incidence of AEs than routine-dose groups (21 L858R-RD vs 21 L858R-HD vs 19 del: 54.7% vs 81.1% vs 66.2%, p=0.0007), but the incidences of grade 3/4 AE were similar among the groups (4.7% vs 5.6% vs 5.2%, p=0.9632).

      pfs by irc.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      A prolonged PFS and improved ORR were observed in patients treated with high-dose icotinib in NSCLC patients harboring 21 L858R mutation with tolerable toxicity.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-47 - Clinical Characteristics and Outcome for Patients with Advanced Lung Adenocarcinoma Treated with First-Line Pemetrexed Plus Platinum (ID 13078)

      12:00 - 13:30  |  Author(s): Xingsheng Hu

      • Abstract
      • Slides

      Background

      To evaluate the efficacy and safety of pemetrexed combined with platinum first-line therapy for advanced lung adenocarcinoma, as well as the clinical factors influencing outcomes.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      We retrospectively evaluated the data from 450 pemetrexed-treated patients with stage IIIb/IV lung adenocarcinoma that confirmed by cytology or histology from February 2011 to August 2017. Patients were divided into 2 groups according to the presence of maintenance therapy (yes or no) after the first-line chemotherapy. The primary endpoint was progression-free survival (PFS), secondary endpoints included objective response rate (ORR), disease control rates (DCR), and safety.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 292 received only first-line pemetrexed-based therapy, while 158 patients received maintenance pemetrexed after induction. The overall median PFS was 5.83 months (95% CI was 0.33 to 55.72 months). The maintenance treatment group had longer PFS (9.92 months, 95%CI: 3.98 to 5.21 months) than (P < 0.001) the non-maintenance treatment group (4.60 months, 95%CI: 8.70 to 11.14 months) after the first line chemotherapy (P < 0.001). The ORR and DCR of 450 patients with lung adenocarcinoma was 33.6% and 87.6%, respectively. Single-factor and multiple-factor analysis showed that positive mutation of epidermal growth factor receptor (EGFR), PS 0, exposure more than 4 cycles, and the addition of maintenance treatment were the positive prognostic factors for survival. The main adverse reactions of the patients were hematological toxicity, gastrointestinal reaction, abnormal and asthenia of liver function. However, low incidence of grade 3 or higher toxicity was seen in this study.

      8eea62084ca7e541d918e823422bd82e Conclusion

      First-line therapy with pemetrexed combined with platinum is safe and effective for advanced lung adenocarcinoma, and pemetrexed maintenance therapy has a better survival benefit.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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