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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)

HEMATOLOGIC adverse REACTIONS SUMMARY

INTEGRATED SAFETY ANALYSIS OF ES-SCLC PATIENTS

  • The summary of hematologic adverse reactions based on the integrated safety dataset from across the 3 studies. The patients included are those randomized patients who received at least 1 dose of COSELA® (trilaciclib) or placebo. The data reflect adverse reactions observed by investigators at any time during the treatment period

GRADE 3/4 Hematologic Adverse REACTIONS (Integrated Safety Dataset OF ES-SCLC PATIENTS FROM ACROSS THE 3 STUDIES)

69%Neutropenia0102030405032%9%3%34%16%6070Febrile NeutropeniaAnemiaThrombocytopeniaLeukopeniaLymphopenia33%18%17%4%<1%<1%Chemotherapy Regimens with COSELA (N=122)Chemotherapy Regimens (N=118)
69%Neutropenia0102030405032%9%3%34%16%6070FebrileNeutropeniaAnemiaThrombo- cytopeniaLeukopeniaLymphopenia33%18%17%4%<1%<1%Chemotherapy Regimens with COSELA (N=122)Chemotherapy Regimens (N=118)

Results were not statistically compared.

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).

HEAR FROM A PEER

LEARN ABOUT HEMATOLOGIC ADVERSE REACTIONS THAT OCCURRED WITH COSELA

Hear leading medical oncologist Dr. Edward Kim, M.B.A., M.D., provide a summary of the hematologic adverse reactions of COSELA.

NOTE: Dr. Kim is appearing on behalf of G1 Therapeutics, Inc.

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See Transcript

HEMATOLOGIC ADVERSE REACTIONS SUMMARY

Trilaciclib clinical effectiveness was measured using neutropenia end points defined by criteria based on lab values.

Safety was a key secondary endpoint and was assessed based on the integrated data set, which included hematologic adverse events observed at any time during the treatment period by the investigators.

Given the mechanism of action of trilaciclib, these hematologic endpoints are points of interest. This is the overall summary table of hematologic events.

It gives an overview of the higher Grade 3/4 incidence of hematologic events.

INDICATION

COSELA® (trilaciclib) 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).

SELECT IMPORTANT SAFETY INFORMATION

  • COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.
  • Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.
  • The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please see full Prescribing Information at COSELA.com.

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PATIENT SUPPORT PROGRAM

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HEAR FROM PEERS

Sujith Kalmadi, MD, describes how potential safety issues can be mitigated.

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