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 >

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

SEE HOW COSELA IMPACTS MULTIPLE BLOOD CELL LINEAGES AND HELPS SUPPORT A PATIENT’S TREATMENT PLAN

Hear leading medical oncologist Dr. Edward Kim, M.B.A., M.D., share key insights about COSELA.

NOTE: Dr. Kim is appearing on behalf of G1 Therapeutics, Inc.

Neutropenia Data

(01:55)

Red Blood Cell-Related Data

(03:28)

Chemotherapy Dose Reduction Data

(01:54)

Neutropenia Data

(01:55)

See Transcript

A PROACTIVE APPROACH TO SIGNIFICANTLY REDUCE THE OCCURRENCE OF SEVERE NEUTROPENIA

In the pivotal trilaciclib study, you can see that 49% of patients receiving a chemotherapy, immunotherapy regimen had severe neutropenia occur. We still have quite a few people who will suffer from neutropenia with these chemotherapy-based regimens.

But the addition of trilaciclib to the regimen reduced that incidence significantly, down below 2%, so there was a marked difference. And the number of days that a patient has severe neutropenia occurring could lead to chemotherapy dose reductions.

With trilaciclib, this time was significantly reduced in the first cycle.

INDICATION

COSELA™ (trilaciclib) 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).

SELECT IMPORTANT SAFETY INFORMATION

  • COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.
  • Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.
  • The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please see full Prescribing Information.

Red Blood Cell-Related Data

(03:28)

See Transcript

STUDIED ACROSS MULTIPLE RBC-RELATED ENDPOINTS

What was revealed in the studies was not just protection from severe neutropenia but also protection of the red blood cell lineage.

SECONDARY AND EXPLORATORY ENDPOINTS FOR RBCs WERE EVALUATED ACROSS STUDIES

For the secondary endpoints, you can see what the numbers were (for those who were treated with placebo vs COSELA) when considering incidence of Grade 3/4 decreased hemoglobin or those who required hemoglobin transfusions (and they all trended in the appropriate direction).

For instance, the rate of RBC transfusions over time was 1.7 per 100 weeks for patients who received COSELA and 2.6 for every 100 weeks for patients receiving placebo.

This is Study 2. This proof-of-concept study was assessing safety and tolerability. And there were preliminary efficacy objectives, which were secondary or exploratory.

What this trial showed, in Study 2, was that 10% of patients receiving COSELA had a Grade 3 or 4 decreased hemoglobin compared with 18% of patients receiving placebo. And the rate of RBC transfusions over time was 0.5 over 100 for patients who received COSELA and 1.9 per 100 weeks for patients receiving placebo.

This is Study 3, which was a previously treated study. Thirty-eight percent of patients receiving COSELA had Grade 3 or 4 decreased hemoglobin compared with 59% of patients receiving placebo. You can see consistent with the other 2 studies, despite this one being a second-line, previously treated chemotherapy study, that we’re seeing the same patterns.

INDICATION

COSELA™ (trilaciclib) 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).

SELECT IMPORTANT SAFETY INFORMATION

  • COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.
  • Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.
  • The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please see full Prescribing Information.

Chemotherapy Dose Reduction Data

(01:54)

See Transcript

IMPACT ON CHEMOTHERAPY DOSE REDUCTIONS

We know that some folks like to automatically start with dose reductions, even at the first cycle.

You can see that in the Pivotal Trial, the number of dose reductions was much less when using trilaciclib versus the regimens without trilaciclib.

ADDITIONAL PIVOTAL TRIAL DATA

Carboplatin/etoposide dose reductions occurred in 25% and 26% of patients without COSELA vs 2% and 6% of patients with COSELA.

Being able to preserve dose can be very important to the treatment of patients with small cell lung cancer.

INDICATION

COSELA™ (trilaciclib) 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).

SELECT IMPORTANT SAFETY INFORMATION

  • COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.
  • Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.
  • The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please see full Prescribing Information.

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).