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Poster Discussion - Non-metastatic NSCLC and other thoracic malignancies

5386 - Trilaciclib (T) decreases myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients receiving 1st line chemotherapy plus atezolizumab

Date

29 Sep 2019

Session

Poster Discussion - Non-metastatic NSCLC and other thoracic malignancies

Presenters

Davey Daniel

Citation

Annals of Oncology (2019) 30 (suppl_5): v710-v717. 10.1093/annonc/mdz264

Authors

D. Daniel1, V. Kuchava2, I. Bondarenko3, O. Ivashchuk4, D. Spigel5, A. Dasgupta6, S. Reddy7, T. Melkadze8, J. Jaal9, I. Kudaba10, L. Hart11, A. Matitashvili12, K.D. Koynov13, Z.(. Yang14, S.G. Wolfe15, R. Malik16, S.R. Morris17, J.M. Antal18, J. Goldschmidt19

Author affiliations

  • 1 Oncolology, Sarah Cannon Research Institute, Tennessee Oncology-Chattanooga, 37404 - Chattanooga/US
  • 2 Oncology, LTD Clinical Oncology Center, 0159 - Tbilisi/GE
  • 3 Oncology And Medical Radiology Department, Dnipropetrovsk city multidisciplinary clinical hospital №4, 49102 - Dnipro/UA
  • 4 Oncology, Chernivtsi Regional Clinical Oncology Center, 58013 - Chernivtsi/UA
  • 5 Tennessee Oncology, Sarah Cannon Research Institute, 37203 - Tennessee/US
  • 6 Medical Oncology, Millennium Oncology, 77090 - Houston, TX/US
  • 7 Oncology, Northside Hospital, Inc, 30341 - Atlanta/US
  • 8 Oncology, LTD Research Institute of Clinical Medicine, 0112 - Tbilisi/GE
  • 9 Hematology/oncology, Tartu University Hospital, 51014 - Tartu/EE
  • 10 Latvian Oncology Center, Riga East University Hospital, LLC, 1038 - Riga/LV
  • 11 Oncology, Florida Cancer Specialists, 33905 - Fort Myers/US
  • 12 Oncology, LTD Cancer Research Centre, 0177 - Tbilisi/GE
  • 13 Oncology, Multiprofile Hospital for Active Treatment, 1303 - Sofia/BG
  • 14 Biostatistics, G1 Therapeutics, 27709 - Research Triangle Park/US
  • 15 Clinical Operations, G1 Therapeutics, 27709 - Research Triangle Park/US
  • 16 Cmo, G1 Therapuetics, Inc, 27709 - Research Triangle Park/US
  • 17 Clinical Development, G1 Therapeutics, 27709 - Research Triangle Park/US
  • 18 Clinical Development, G1 Therapeutics, Inc., 27709 - Research Triangle Park/US
  • 19 Oncology, Blue Ridge Cancer Center, 24060 - Blacksburg/US
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Resources

Abstract 5386

Background

Chemotherapy (chemo)-induced damage of hematopoietic stem and progenitor cells (HSPC) causes multi-lineage myelosuppression. Current supportive therapies are lineage specific and administered after damage has occurred. T, a highly selective, reversible CDK4/6 inhibitor and first-in-class myelopreservation agent, preserves HSPCs during chemotherapy, improving its safety and tolerability. This trial (NCT03041311) studied the benefits of T in ES-SCLC patients receiving 1L chemo + atezolizumab (A).

Methods

This placebo (P)-controlled, double-blind, Ph2 study randomized (1:1) chemo-naïve ES-SCLC pts with adequate organ function, ECOG 0-2, and no symptomatic brain mets, to T or P with etoposide/carboplatin/A (ECA) for four induction cycles followed by maintenance (A). Prophylactic growth factors were prohibited in cycle 1; otherwise standard supportive care was allowed. Prespecified lineage-specific endpoints assessed the effect of T on myelosuppression. Tumor response was assessed using RECIST v1.1. FACT-L and FACT-An were evaluated.

Results

T + ECA was well tolerated with fewer ≥ G3 AEs in T (62% overall; 50% any drug related) vs P (87%; 74%), primarily due to less heme toxicity. T improved ANC, RBC measures and SOC interventions (Table). T also delayed time to deterioration in some PRO functioning domains and anemia symptoms. T did not affect chemo efficacy as measured by ORR and PFS; OS will be presented.Table: 1742PD

Parameter, n [1]ECA + P N = 53ECA + T N = 54Adjusted 1-sided P- value
Mean Duration (d) G4 ANC in Cycle 1[2]40<0.0001
Pts w G4 ANC*26 (49%)1 (2%)<0.0001
Dose reductions (per 100 cycles) ǂ8.52.10.0195
Pts w RBC transfusions ≥ week 5*11 (21%)7 (13%)0.1335
Pts w G-CSF Admin*25 (47%)16 (30%)0.0686

[1] Data presented as proportion (*) or event rate (ǂ) [2] Surrogate for febrile neutropenia

Conclusions

Addition of T improves safety/tolerability of chemo as shown by statistically significant and clinically meaningful improvement in myelosuppression endpoints, reduction of chemo side effects, and SOC interventions and no detriment to anti-tumor efficacy. These data confirm the myelopreservation benefits of T seen in another 1L ES-SCLC trial (NCT02499770).

Clinical trial identification

GIT28-05: NCT03041311, EudraCT2017-000358-20.

Editorial acknowledgement

Legal entity responsible for the study

G1 Therapeutics, Inc.

Funding

G1 Therapeutics, Inc.

Disclosure

D. Daniel: Research grant / Funding (institution): G1 Therapeutics; Research grant / Funding (institution): ER Squibb & sons; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingleheim; Research grant / Funding (institution): Genentech; Research grant / Funding (institution): Eli Lilly and Company; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Roche. D. Spigel: Advisory / Consultancy, Research grant / Funding (institution): Genentech/Roche; Research grant / Funding (institution): G1 Therapeutics. J. Jaal: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim. L. Hart: Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: G1 Therapeutics. K.D. Koynov: Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Roche; Honoraria (institution): Boehringer Ingelheim; Honoraria (institution): servier; Honoraria (institution): Novartis; Honoraria (institution): Merck; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: MSD; Honoraria (institution): Bayer; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Eli Lilly; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Astelas; Honoraria (self), Honoraria (institution), Travel / Accommodation / Expenses: Amgen; Honoraria (institution): Intellect Pharma; Travel / Accommodation / Expenses: AstraZeneca. Z.(. Yang: Full / Part-time employment: G1 Therapeutics. S.G. Wolfe: Full / Part-time employment: G1 Therapeutics. R. Malik: Full / Part-time employment: G1 Therapeutics. S.R. Morris: Full / Part-time employment: G1 Therapeutics. J.M. Antal: Full / Part-time employment: G1 Therapeutics. All other authors have declared no conflicts of interest.

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