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 PatientsSee Study Design
RBC LINEAGE1Secondary Endpoints
PLATELET LINEAGE1Secondary Endpoints
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).|
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).
Hematologic Adverse Reactions Summary
HEAR FROM PEERS
Sujith Kalmadi, MD, describes the reductions in myelosuppression he has seen with COSELA.