Neutrophil cell

To decrease the incidence of chemotherapy-induced myelosuppression in patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen

For extensive-stage small cell lung cancer (ES-SCLC)

PROACTIVELY HELPS PROTECT PATIENTS AGAINST MULTIPLE MYELOSUPPRESSIVE CONSEQUENCES

PIVOTAL STUDY ENDPOINTS: COSELA® (trilaciclib) Proactively Given Prior to Etoposide, Carboplatin, and Atezolizumab in 1st-Line ES-SCLC Patients

See Study Design 
PLATELET LINEAGE1RBC LINEAGE1NEUTROPHIL LINEAGE1Primary EndpointsSecondary EndpointsE/P/A Regimen with COSELA (N=54)E/P/A Regimen (N=53)P< 0.0001*†49.1%010203040501.9%P< 0.0001*‡4DAYS0DAYSP= 0.31055.7%1.9%Grade 4 SevereNeutropenia(% Patients)Mean Duration(Days) of Grade4 SN in Cycle 1FN AEs(% Patients)P= 0.3243§28%19%P= 0.1335*ll20.8%13.0%Grade 3/4Anemia(% Patients)RBC Transfusions≥ Week 5(% Patients)P= 0.0026¶#37.7%1.9%P= 0.5501#3.8%1.9%Grade 3/4Thrombocytopenia(% Patients)PlateletTransfusions(% Patients)

NEUTROPHIL LINEAGE1

P< 0.0001*†49.1%Grade 4 SevereNeutropenia(% Patients)010203040501.9%P< 0.0001*‡Mean Duration(Days) of Grade4 SN in Cycle 140P= 0.3105FN AEs(% Patients)5.7%1.9%PrimaryEndpointsSecondaryEndpointE/P/A Regimen with COSELA (N=54)E/P/A Regimen (N=53)

RBC LINEAGE1Secondary Endpoints

P= 0.3243§28%Grade 3/4Anemia(% Patients)19%P= 0.1335*ll20.8%13.0%RBC Transfusions≥ Week 5(% Patients)01020304050E/P/A Regimen with COSELA (N=54)E/P/A Regimen (N=53)

PLATELET LINEAGE1Secondary Endpoints

PlateletP= 0.0026¶#37.7%Grade 3/4Thrombocytopenia(% Patients)1.9%3.8%1.9%P= 0.5501#Transfusions(% Patients)01020304050E/P/A Regimen with COSELA (N=54)E/P/A Regimen (N=53)

Data are from the induction phase. P values are raw one-sided or multiplicity-adjusted.

* Multiplicity-adjusted P value. (All other P values are raw one-sided.)
† Adjusted relative risk (aRR) 0.038 (95% CI, 0.008, 0.195)
‡ Mean difference -3.6 (95% CI, -4.9, -2.3)
§ aRR 0.663 (95% CI, 0.336, 1.310)
‖ aRR 0.642 (95% CI, 0.294, 1.404)
aRR 0.053 (95% CI, 0.008, 0.356)
# Results for platelet endpoints including incidence of Grade 3/4 thrombocytopenia and platelet transfusions were not consistent across COSELA clinical trials. See Study 2. See Study 3.

Grade 3/4 anemia was defined as Grade 3/4 decreased hemoglobin.

Standard-of-care supportive interventions, including RBC and platelet transfusions, were allowed per investigator discretion throughout the entire treatment period. Primary prophylaxis with granulocyte colony-stimulating factors (G-CSFs) and use of erythropoiesis stimulating agents (ESAs) were prohibited in cycle (C) 1 of induction, although therapeutic G-CSF was allowed in all cycles. More patients in the E/P/A regimen arm without COSELA received G-CSF Administration (47.2% vs 29.6%, aRR 0.646 [95% CI, 0.403, 1.034]) and had ESA use (11% vs 6%, aRR 0.529 [95% CI, 0.145, 1.927]) vs with COSELA, respectively.

E/P/A Regimen Arm=E/P/A + Placebo

AE=Adverse Event

FN=Febrile Neutropenia

View Pivotal Study publication
on PubMed >
HEAR FROM A PEER

THE MULTILINEAGE DATA THAT COMPELLED HEALTHCARE PROVIDERS TO ADOPT COSELA

Jason Porter, MD
(02:15)
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Jason Porter, MD
(02:15)

COSELA HELPS SUPPORT YOUR TREATMENT PLAN

PIVOTAL STUDY SECONDARY ENDPOINTS: The rate of all-cause chemotherapy dose reductions, events per 100 cycles, was significantly lower with COSELA, added to an E/P/A regimen: 2.1 vs 8.5 without COSELA (aRR: 0.242 [95% CI, 0.079, 0.742], P=0.0195).

See Study Design 

FEWER PATIENTS REQUIRED DOSE
REDUCTIONS OF CARBOPLATIN1

E/P/A Regimen with COSELA (N=54)E/P/A Regimen (N=53)

FEWER PATIENTS REQUIRED DOSE
REDUCTIONS OF ETOPOSIDE1

E/P/A Regimen with COSELA (N=54)E/P/A Regimen (N=53)

Dose reductions of carboplatin occurred in 2% of patients receiving COSELA and in 25% of patients receiving placebo; dose reductions of etoposide occurred in 6% of patients receiving COSELA and in 26% of patients receiving placebo. No dose reduction was allowed for COSELA or atezolizumab.

Visual representations are based on the clinical data. Statistical comparisons were not made between groups.

… fewer patients in the trilaciclib group had dose delays or reductions compared with the placebo group, suggesting that the administration of trilaciclib prior to chemotherapy helped facilitate the delivery of chemotherapy according to the standard dose and schedule.Trilaciclib prior to chemotherapy and atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer: a multicentre, randomised, double-blind, placebo-controlled Phase II trial. Int J Cancer. 2021;148:2557-2570.““

NUMBER OF PATIENTS WITH CHEMOTHERAPY CYCLE DELAYS1

Cell cycle delays can be a result of hematological toxicity or other factors.

Results were not statistically compared.

HEAR FROM A PEER

HEALTHCARE PROVIDERS SHARE HOW CHEMOTHERAPY DELAYS IMPACT PATIENTS AND PRACTICES

Jason Porter, MD
(02:34)
Monica Tripodi, APRN, MSN, FNP-C, AOCNP
(02:34)

INDICATION: COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

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Hematologic Adverse Reactions Summary

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See 2nd-/3rd-Line Data > See Study Design >
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HEAR FROM PEERS

Sujith Kalmadi, MD, describes the reductions in myelosuppression he has seen with COSELA.

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