Cells

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)

ADDITIONAL MYELOPROTECTION EFFICACY DATA IN 1ST-LINE PATIENTS

STUDY 2 ENDPOINTS: COSELA™ (trilaciclib) Proactively Given Prior to Etoposide and Carboplatin (E/P) in 1st‑Line ES‑SCLC Patients

See Study Design 
8%Grade 3/4Thrombocytopenia(% Patients)8%0%5%PlateletTransfusions(% Patients)18%Grade 3/4Anemia(% Patients)10%23.7%5.1%RBC Transfusions≥ Week 5(% Patients)PLATELET LINEAGE1RBC LINEAGE1NEUTROPHIL LINEAGE142.1%Grade 4 SevereNeutropenia(% Patients)010203040505.1%Mean Duration(Days) of Grade 4SN in Cycle 130FN AEs*(% Patients)8%3%E/P Regimen with COSELA (N=39)E/P Regimen (N=38)

NEUTROPHIL LINEAGE1

E/P Regimen with COSELA (N=39)E/P Regimen (N=38)42.1%Grade 4 SevereNeutropenia(% Patients)010203040505.1%Mean Duration(Days) of Grade 4SN in Cycle 130FN AEs*(% Patients)8%3%

RBC LINEAGE1

18%Grade 3/4Anemia(% Patients)10%23.7%5.1%RBC Transfusions≥ Week 5(% Patients)E/P Regimen with COSELA (N=39)E/P Regimen (N=38)01020304050

PLATELET LINEAGE1

E/P Regimen with COSELA (N=39)E/P Regimen (N=38)010203040508%Grade 3/4Thrombocytopenia(% Patients)8%0%5%PlateletTransfusions(% Patients)

E/P Regimen = E/P + Placebo. Grade 3/4 anemia defined as Grade 3/4 decreased hemoglobin. Supportive care was allowed as described in the Pivotal Study. In Study 2, a G-CSF was administered to 63.2% of patients in the Placebo Group and 10.3% in the COSELA Group at least one time; 3% of patients receiving COSELA received ESAs compared with 5% of patients receiving placebo.

Data from clinical study publication:

* Placebo, 8% (3/37); COSELA, 3% (1/38).
Data represent incidence as reported as a treatment-emergent adverse event: Placebo, 8% (3/37), COSELA, 8% (3/38).
Placebo, 0% (0/37); COSELA, 5% (2/38).

AE=Adverse Event

FN=Febrile Neutropenia

INCIDENCE OF CHEMOTHERAPY DOSE REDUCTIONS

STUDY 2 ENDPOINT: The rate of all-cause dose reductions, events per 100 cycles, was 2.2 with COSELA and 8.4 without COSELA. Dose reductions of etoposide/carboplatin are shown.

STUDY 2: % OF PATIENTS WITH DOSE REDUCTIONS OF ETOPOSIDE/CARBOPLATIN

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

Data from clinical study publication:

§ Placebo, 35.1% (13/37); COSELA, 7.9% (3/38).

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).