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

NEUTROPHIL LINEAGE¹

RBC LINEAGE¹

PLATELET LINEAGE¹

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^1§

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).