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Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies

3815 - Trilaciclib (T) decreases multi-lineage myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients receiving 1st line chemotherapy


21 Oct 2018


Poster Discussion session - Non-metastatic NSCLC and other thoracic malignancies


Cytotoxic Therapy

Tumour Site


Konstantin Dragnev


Annals of Oncology (2018) 29 (suppl_8): viii596-viii602. 10.1093/annonc/mdy298


K.H. Dragnev1, T.K. Owonikoko2, T. Csoszi3, M. Maglakelidze4, J.T. Beck5, M. Domine Gomez6, A. Lowczak7, A. Fulop8, R.J. Hoyer9, W. Hanna10, P. Lowry11, R. Aljumaily12, V.K. Chiu13, I. Bulat14, Z. Yang15, P.J. Roberts16, J.M. Antal17, R.K. Malik18, S.R. Morris17, J.M. Weiss19

Author affiliations

  • 1 Hematology/oncology, Norris Cotton Cancer Center Dartmouth-Hitchcock Medical Center, 3756 - Lebanon/US
  • 2 Department Of Hematology And Medical Oncology, Winship Cancer Institute, Emory University, 30322 - Atlanta/US
  • 3 Oncology, Hetenyi Geza Korhaz, Onkologiai Kozpont, 5004 - Szolnok/HU
  • 4 Oncology, Research Institute of Clinical Medicine, 0112 - Tbilisi/GE
  • 5 Medical Oncology And Hematology, Highlands Oncology Group, Fayetteville/US
  • 6 Oncology, University Hospital "Fundacion Jimenez Diaz", 28040 - Madrid/ES
  • 7 Oncology, Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Olsztyn/PL
  • 8 Oncology, OKTPI-Korányi National Institute for Tuberculosis and Pulmonology, 1121 - Budapest/HU
  • 9 Oncology, Memorial Hospital, University of Colorado Health, Colorado Springs/US
  • 10 Hematology/oncology, University of Tennessee Medical Center, knoxville/US
  • 11 Oncology, Guthrie Medical Group, Sayre/US
  • 12 Oncology, Oklahoma University Medical Center, Oklahoma City/US
  • 13 Hematology/oncology, University of New Mexico Comprehensive Cancer Center, Albuquerque/US
  • 14 Oncology, ICS ARENSIA Exploratory Medicine SRL, Chisinau/MD
  • 15 Biostatistics, G1 Therapeutics, Inc., Research Triangle Park/US
  • 16 Translational Medicine, G1 Therapeutics, Inc, NC 27709 - Research Triangle Park/US
  • 17 Clinical Development, G1 Therapeutics, Inc., Research Triangle Park/US
  • 18 Clinical Development, G1 Therapeutics, Inc., Research Triangle park/US
  • 19 Hematology/oncology, University of North Carolina at Chapel Hill, Chapel Hill/US


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Abstract 3815


Chemotherapy (chemo)-induced damage of hematopoietic stem and progenitor cells (HSPC) causes multi-lineage myelosuppression. T is an iv CDK4/6i in development to preserve HSPC and immune system function during chemo (myelopreservation). Preclinically, transient T-induced G1 arrest renders HSPCs resistant to chemo cytotoxicity, leading to faster hematopoietic recovery and enhanced anti-tumor immunity.


This Phase 2, randomized, placebo (P)-controlled, double-blind study dosed 75 chemo-naïve ES-SCLC pts with adequate organ function, ECOG 0-2, and no symptomatic brain metastases (NCT02499770). Pts received T or P iv prior to etoposide/carboplatin (EP) on days 1 to 3 of each cycle. Growth factors were prohibited in cycle 1; otherwise supportive care was allowed as needed. Lineage-specific endpoints were prespecified to assess the effect of T on myelosuppression. Tumor response was assessed using RECIST v1.1.


Key results are in the table. T + EP was well tolerated with fewer ≥ G3 AEs in T (50%) vs P (83.8%), primarily due to less hematological (heme) toxicity. No T-related ≥ G3 AEs occurred. Improvements were seen with T in neutrophil, RBC and lymphocyte measures in all pt subgroups. There was an increase in activated CD8+ T-cells and a decrease in regulatory T-cells in the peripheral blood (PB) with T. Tumor assessment showed: objective response rate (T 66.7%, P 62.2%); DOR (median T 5.7m, P 4.3m); and PFS (median T 6.2m, P 5.0m; HR 0.6, p = 0.06).Table: 1666PD

Parameter, nEP + P N = 37EP + T N = 38P-value (1)
G4 ANC1620.0001
G-CSF Administration244<0.0001
Febrile Neutropenia310.2773
RBC transfusion ≥ 5 weeks on study820.0781
Dose reductions due to heme toxicity1220.0029
Lymphocyte count at end of 6 cycles(2)1.608 x 109/L1.935 x 109/L0.0499

Significance testing at 2-sided α = 0.2 P, n = 22; T, n = 20


Trilaciclib demonstrated (1) myelopreservation across three hematopoietic lineages with fewer supportive care interventions and dose reductions, (2) encouraging DOR and PFS, and (3) changes in peripheral blood T-cell subsets indicating a more robust immune response. These data demonstrate strong proof-of-concept for the myelopreservation benefits of T.

Clinical trial identification

NCT02499770; EudraCT: 2016-001583-11.

Legal entity responsible for the study

G1 Therapeutics, Inc.


G1 Therapeutics, Inc.

Editorial Acknowledgement


Z. Yang, P.J. Roberts, J.M. Antal, R.K. Malik, S.R. Morris: Employee: G1 Therapeutics. J.M. Weiss: Financial support to institution: AstraZeneca, Celgene, Merck; Advisory board: AstraZeneca, Celgene, Boston Biomedical. All other authors have declared no conflicts of interest.

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