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Qingyuan Zhang



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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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      P1.01-06 - Plinabulin, a Novel Immuno-Oncology Agent Mitigates Docetaxel Chemotherapy -Induced-Neutropenia and -Thrombocytopenia in NSCLC Patients. (ID 13016)

      16:45 - 18:00  |  Author(s): Qingyuan Zhang

      • Abstract
      • Slides

      Background

      Plinabulin (Plin) is a novel non-GCSF small molecule with anti-cancer activity, in development for prevention of Chemotherapy (Chemo)-Induced-Neutropenia (CIN) and under evaluation with induced by Docetaxel (Doc), Adriamycin, Cyclophosphamide, Irinotecan, Gemcitabine, Carboplatin, Abraxane). Plin is administered as a single IV infusion per cycle, and on the same day of Chemo, 30 minutes after Chemo. In contrast to G-CSF, Plin has anti-cancer, immune-enhancing activity due to dendritic cell activation and related T-cell proliferation, and Plin does not cause bone pain. Our randomized phase (Ph) 2 study 101 (NCT00630110) in lung cancer (NSCLC) with Docetaxel (Doc) 75 mg/M2 +/- Plin established the baseline for Grade 4 neutropenia without Plin. We recently completed the Ph2 portion of the Ph2/3 Study 105 (NCT03102606), comparing Plin with Pegfilgrastim (Peg) for Doc CIN prevention in NSCLC. The 20 mg/m2 Plin dose was equally effective as Peg for CIN, and this dose will be taken into Ph3. The CIN nadir was earlier with Peg, and occurrence of bone pain was higher with Peg vs Plin (33% vs 11%, resp), suggesting a different mechanism of action (MoA). To further understand Plin’s MoA, we analyzed hematology results with Plin and Peg treated subjects.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Ph2 Study 105: NSCLC Pts were randomized to Doc 75 mg/ m2 day (D)1, and either Peg 6 mg D2 (n=14), or Plin at 5 (n=14),10 (n=13), 20 (n=14) mg/ m2 D1 (30 minutes after Doc). Blood for central hematology analysis was collected through Cycle 1. Grade (Gr) 4 neutropenia data without Plin (that is Plin 0 mg/ m2) data was taken from study 101.

      4c3880bb027f159e801041b1021e88e8 Result

      Docetaxel-induced Gr 4 Neutropenia was 14%, 23%, 14%, 33% when Doc was combined with Plin at a dose of 20, 10, 5, 0 mg/ m2 . At the highest Plin dose of 20 mg/ m2, Gr 4 Neutropenia frequency (14% for Plin or Peg) and Duration of Grade 4/Severe Neutropenia (DSN; 0.5 days for Plin or Peg) were similar for Plin and Peg, however Gr 4 thrombocytopenia frequency was 50% with Peg and 36% with Plin. All Grade thrombocytopenia was significantly higher (p=0.036) with Peg vs Plin.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Plin appears to be equally effective as Peg against Doc CIN, however Plin, but not Peg, reduced Doc-induced thrombocytopenia. This is further indication of a difference in MoA for Plin vs Peg.

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    P2.04 - Immunooncology (Not CME Accredited Session) (ID 953)

    • 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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      P2.04-29 - Preliminary Results With Tislelizumab in Chinese Patients With Non-Small Cell Lung Cancer (NSCLC) (ID 11319)

      16:45 - 18:00  |  Author(s): Qingyuan Zhang

      • Abstract
      • Slides

      Background

      NSCLC accounts for 80–85% of all lung cancers and has a poor prognosis at later stages. Immune checkpoint inhibitors have shown efficacy in patients (pts) with advanced NSCLC. Tislelizumab is a humanized IgG4 monoclonal antibody with high affinity/specificity for PD-1. Tislelizumab was specifically engineered to minimize FcϒR binding on macrophages that, based on preclinical evidence, is believed to minimize potentially negative interactions with other immune cells. In a phase 1 study, tislelizumab was generally well tolerated and showed antitumor activity in NSCLC pts; 200 mg IV Q3W was established as the recommended tislelizumab dose.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      In the ongoing indication-expansion phase of this study, Chinese pts with histologically confirmed NSCLC were enrolled into PD-L1-high (PD-L1+; 10% tumor cells expressing PD-L1) and PD‑L1‑low (PD-L1) cohorts. Antitumor activity (RECIST v1.1) and safety/tolerability (NCI-CTCAE v4.03) were assessed.

      4c3880bb027f159e801041b1021e88e8 Result

      As of 8 Dec 2017, 42 NSCLC pts (median age 54 yr [range 37–72]) were enrolled; 17 were PD-L1+ and 25 were PD-L1. Most pts were male (69%), former/current smokers (57%), and had received prior therapy (95%). Adenocarcinoma was the most prevalent histology (57%). Median follow-up was 4.5 mo and 23 pts remain on treatment. Of the 39 response-evaluable pts, 4 (n=2/14, PD-L1+; n=2/25, PD-L1) achieved confirmed PR and 20 (n=6/14, PD-L1+; n=14/25, PD‑L1) achieved SD, including 4 (n=2, PD-L1+; n=2, PD‑L1) with unconfirmed PR. Across the study population, ORR was 10% and DCR was 61.5%. ORRs by cohort were 14% (PD‑L1+) and 8% (PD-L1), respectively. Common treatment-related AEs were increased AST (24%), increased ALT (19%), hypothyroidism (12%), and rash (12%). Five grade 3 treatment-related AEs occurred in 4 pts (increased AST [n=2], hyperglycemia, increased ALT, and increased GGT [n=1 each]). No treatment-related grade 5 events were reported.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Tislelizumab was generally well tolerated and demonstrated antitumor activity in previously treated pts with advanced NSCLC. A global phase 3 study (NCT03358875) of tislelizumab vs docetaxel as potential second/third-line therapy in NSCLC pts who progressed after a platinum-based regimen is ongoing.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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