1742PD - Trilaciclib (T) decreases myelosuppression in extensive-stage small cell lung cancer (ES-SCLC) patients receiving first-line chemotherapy plus atezolizumab

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 myelopreser...

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Veröffentlicht in:Annals of oncology 2019-10, Vol.30, p.v713-v713
Hauptverfasser: Daniel, D., Kuchava, V., Bondarenko, I., Ivashchuk, O., Spigel, D., Dasgupta, A., Reddy, S., Melkadze, T., Jaal, J., Kudaba, I., Hart, L., Matitashvili, A., Koynov, K.D., Yang, Z., Wolfe, S.G., Malik, R., Morris, S.R., Antal, J.M., Goldschmidt, J.
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Sprache:eng
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Zusammenfassung: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). 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. 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: 1742PDTable: 1742PDParameter, n [1]ECA + P N=53ECA + T N=54Adjusted 1-sided P- valueMean Duration (d) G4 ANC in Cycle 1[2]40
ISSN:0923-7534
1569-8041
DOI:10.1093/annonc/mdz264.006