A cluster of blood 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)

MYELOPROTECTION EFFICACY DATA IN 2ND- AND 3RD-LINE PATIENTS

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

See Study Design 
Grade 4 SevereNeutropenia(% Patients)Mean Duration(Days) of Grade4 SN in Cycle 1FN AEs(% Patients)PLATELET LINEAGE1RBC LINEAGE1NEUTROPHIL LINEAGE1Primary EndpointsSecondary Endpoints0102030406040.6%7217.2%6.3%80705075.9%Grade 3/4Thrombocytopenia*(% Patients)PlateletTransfusions(% Patients)Grade 3/4Anemia*(% Patients)RBC Transfusions≥ Week 5(% Patients)59%38%41.4%31.3%25.0%31.0%53.1%57.2%Topotecan Regimen with COSELA (N=32)Topotecan Regimen (N=29)

NEUTROPHIL LINEAGE1

Grade 4 SevereNeutropenia(% Patients)0102030406040.6%Mean Duration(Days) of Grade4 SN in Cycle 17DAYS2DAYSFN AEs(% Patients)17.2%6.3%80705075.9%PrimaryEndpointsSecondaryEndpointTopotecan Regimen with COSELA (N=32)Topotecan Regimen (N=29)

RBC LINEAGE1Secondary Endpoints

Grade 3/4Anemia(% Patients)41.4%31.3%RBC Transfusions≥ Week 5(% Patients)59%38%01020304060807050Topotecan Regimen with COSELA (N=32)Topotecan Regimen (N=29)

PLATELET LINEAGE1Secondary Endpoints

57.2%Grade 3/4Thrombocytopenia*(% Patients)53.1%31.0%25.0%01020304060807050PlateletTransfusions(% Patients)Topotecan Regimen with COSELA (N=32)Topotecan Regimen (N=29)

Topotecan Regimen Arm = Topotecan + Placebo. Supportive care was allowed as described in the Pivotal Study. In Study 3, a G-CSF was administered to 65.5% of patients in the Placebo Group and 50.0% in the COSELA Group at least one time. Grade 3/4 anemia defined as Grade 3/4 decreased hemoglobin. 3% of patients receiving COSELA received ESAs compared with 21% of patients receiving placebo.

Data from clinical study publications:

* Data represent incidence as reported as a treatment-emergent adverse event: Placebo, 57.1% (16/28); COSELA 53.1% (17/32).

AE=Adverse Event

FN=Febrile Neutropenia

INCIDENCE OF CHEMOTHERAPY DOSE REDUCTIONS

STUDY 3 SECONDARY ENDPOINT: The rate of all-cause dose reductions, events per 100 cycles, was 5.1 with COSELA vs 11.6 without COSELA. Dose reductions of topotecan are shown.

See Study Design 

STUDY 3: % of Patients with Dose Reductions of Topotecan1

 

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

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).