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Clinical trial efficacy data
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Clinical trial efficacy data
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Clinical trial efficacy data

COSELA was studied in 3 randomized, placebo-controlled registrational studies1-4,a

1L=first-line; 2L=second-line; 3L=third-line; ES-SCLC= extensive-stage small cell lung cancer; ESA=erythropoiesis-stimulating agent; G-CSF=granulocyte colony-stimulating factor.

a

During Cycle 1, primary prophylactic G-CSF and ESA use was prohibited in all 3 studies. Both ESAs and primary prophylactic G-CSF were allowed from Cycle 2 onwards as clinically indicated. Therapeutic G-CSF, RBC, and platelet transfusions were allowed at any time during the studies as clinically indicated.4

b

Treated until disease progression or unacceptable toxicity.4

Key endpoints in Pivotal Study and Study 3

Primary endpoints1,4

  • Percentage of patients with Grade 4 severe neutropenia (absolute neutrophil count >500 cells/µL)
  • Mean number of days with Grade 4 (severe) neutropenia in Cycle 1

Secondary endpoints1,3,4,a

  • Percentage of patients requiring
    • GCSFsa
    • Red blood cell transfusions on/after week 5a
    • Platelet transfusionsb
    • ESAsc
  • Percentage of patients with Grades 3 or 4 hematologic laboratory abnormalitiesc
  • All-cause chemotherapy dose reductionsa
  • Safety and tolerability

Study 2 was a proof-of-concept study with the primary objectives of assessing safety and tolerability; efficacy objectives were secondary or exploratory.2

a
Key secondary endpoints in the Pivotal Study and Study 3.
b
Platelet transfusions were a supportive secondary endpoint in the Pivotal Study and a key secondary endpoint in Study 3.
c
Supportive secondary endpoints in the Pivotal Study and Study 3.