Red blood 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)

STUDIED ACROSS MULTIPLE RBC-RELATED ENDPOINTS

Pivotal study results
Study 2 results
Study 3 results

PIVOTAL STUDY SECONDARY ENDPOINTS: COSELA™ (trilaciclib) Given Prior to Etoposide, Carboplatin, and Atezolizumab (E/P/A) in Patients Newly Diagnosed With ES-SCLC

See Study Design

% OF PATIENTS WITH GRADE 3/4 ANEMIA*

Graph illustrating percentage of patients with Grade 3/4 anemia in the Pivotal StudyPROPORTION OF PATIENTS (%)28%19%E/P/A REGIMEN0%10%20%30%E/P/A REGIMEN WITH COSELA(N=53)(N=54)

Adjusted relative risk 0.663 (95% CI, 0.336, 1.310).

% OF PATIENTS WHO HAD RBC TRANSFUSIONS ON/AFTER 5 WEEKS

Graph illustrating percentage of patients who had RBC transfusions on or after 5 weeks in the Pivotal StudyPATIENTS RECEIVING ≥1 RBC TRANSFUSIONS (%)20.8%13%E/P/A REGIMENE/P/A REGIMEN WITH COSELA0%10%20%30%(N=53)(N=54)

Adjusted relative risk 0.642 (95% CI, 0.294, 1.404).

RATE OF RBC TRANSFUSIONS ON/AFTER 5 WEEKS

Graph illustrating the rate of RBC transfusions on or after 5 weeks in the Pivotal StudyRATE OF RBC TRANSFUSIONS/100 WEEKS0123E/P/A REGIMENE/P/A REGIMEN WITH COSELA1.72.6(N=53)(N=54)

Adjusted relative risk was not estimable.

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

E/P/A Regimen Arm = Placebo + E/P/A. Patients in either arm could receive supportive care as described in the study design.

In Study 1, 6% of patients receiving COSELA received erythropoiesis-stimulating agents (ESAs) compared with 11% of patients receiving placebo (adjusted relative risk 0.529 [95% CI, 0.145, 1.927]).

STUDY 2 ENDPOINTS: COSELA™ (trilaciclib) Given Prior to Etoposide and Carboplatin (E/P) in Patients Newly Diagnosed With ES-SCLC

See Study Design

% OF PATIENTS WITH GRADE 3/4 ANEMIA*

Graph illustrating percentage of ES-SCLC patients with Grade 3/4 anemia in Study 2PROPORTION OF PATIENTS (%)18%10%E/P REGIMEN0%10%20%30%E/P REGIMEN WITH COSELA(N=38)(N=39)

% OF PATIENTS WHO HAD RBC TRANSFUSIONS ON/AFTER 5 WEEKS

Graph illustrating percentage of ES-SCLC patients who had RBC transfusions on or after 5 weeks in Study 223.7%5.1%E/P REGIMENE/P REGIMEN WITH COSELA0%10%20%30%(N=38)(N=39)PATIENTS RECEIVING ≥1 RBC TRANSFUSIONS (%)

RATE OF RBC TRANSFUSIONS ON/AFTER 5 WEEKS

Graph illustrating the rate of ES-SCLC RBC transfusions on or after 5 weeks in Study 20123E/P REGIMENE/P REGIMEN WITH COSELA0.51.9(N=38)(N=39)RATE OF RBC TRANSFUSIONS/100 WEEKS

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

E/P Regimen Arm = E/P + Placebo. Supportive care was allowed as described in the Pivotal Study.

In Study 2, 3% of patients receiving COSELA received ESAs compared with 5% of patients receiving placebo.

STUDY 3 ENDPOINTS: COSELA™ (trilaciclib) Given Prior to Topotecan in 2nd- and 3rd-Line ES-SCLC Patients

See Study Design

% OF PATIENTS WITH GRADE 3/4 ANEMIA*

Graph illustrating percentage of ES-SCLC patients with Grade 3/4 anemia in Study 3PROPORTION OF PATIENTS (%)TOPOTECAN REGIMEN0%10%20%70%TOPOTECAN REGIMEN WITH COSELA(N=29)(N=32)59%38%30%40%50%60%

% OF PATIENTS WHO HAD RBC TRANSFUSIONS ON/AFTER 5 WEEKS

=”Graph illustrating percentage of ES-SCLC patients who had RBC transfusions on or after 5 weeks in Study 3TOPOTECAN REGIMENTOPOTECAN REGIMEN WITH COSELA(N=29)(N=32)0%10%20%70%41.4%31.3%30%40%50%60%PATIENTS RECEIVING ≥1 RBC TRANSFUSIONS (%)

RATE OF RBC TRANSFUSIONS ON/AFTER 5 WEEKS

Graph illustrating the rate of RBC transfusions on or after 5 weeks in Study 30126TOPOTECAN REGIMENTOPOTECAN REGIMEN WITH COSELA(N=29)(N=32)3452.66.3RATE OF RBC TRANSFUSIONS/100 WEEKS

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

Topotecan Regimen Arm = Topotecan + Placebo. Supportive care was allowed as described in the Pivotal Study.

In Study 3, 3% of patients receiving COSELA received ESAs compared with 21% of patients receiving placebo.

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).