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Douglas W. Blayney

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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  |  Presenting Author(s): Douglas W. Blayney

      • Abstract
      • Slides


      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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