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)

COSELA INTEGRATED SAFETY ANALYSIS

ADVERSE REACTIONS

  • The adverse reaction summary here presents pooled safety results from Studies 1, 2, and 3. The patients included in the pooling are those randomized patients that received at least 1 dose of COSELA™ (trilaciclib) (122 patients) or placebo (118 patients)
  • Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis
  • Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each)
  • The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia
  • COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib

Adverse Reactions In ≥5% Patients With ES-SCLC Receiving COSELA (WITH ≥2% HIGHER INCIDENCE WITH COSELA COMPARED TO THE CHEMOTHERAPY REGIMENS GROUP)

CHEMOTHERAPY REGIMENS WITH COSELA (N=122) CHEMOTHERAPY REGIMENS (N=118)
Adverse Reaction All Gradesa (%) Grades 3 (%) All Gradesa (%) Grades 3 (%)
Fatigue 34 3 27 2
Hypocalcemiab 24 <1 21 <1
Hypokalemiac 22 6 18 3
Hypophosphatemiad 21 7 16 2
Aspartate aminotransferase increasede 17 <1 14 <1
Headache 13 0 9 0
Pneumonia 10 7 8 7
Rash 9 <1 6 0
Infusion-related reaction 8 0 2 0
Edema peripheral 7 0 4 <1
Abdominal pain upper 7 0 3 0
Thrombosis 7 3 2 2
Hyperglycemia 6 2 3 0

Adverse Reaction

Fatigue
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
34 3
Chemotherapy Regimens (N=118)
27 2
Hypocalcemiab
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
24 <1
Chemotherapy Regimens (N=118)
21 <1
Hypokalemiac
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
22 6
Chemotherapy Regimens (N=118)
18 3
Hypophosphatemiad
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
21 7
Chemotherapy Regimens (N=118)
16 2
Aspartate aminotransferase increasede
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
17 <1
Chemotherapy Regimens (N=118)
14 <1
Headache
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
13 0
Chemotherapy Regimens (N=118)
9 0
Pneumonia
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
10 7
Chemotherapy Regimens (N=118)
8 7
Rash
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
9 <1
Chemotherapy Regimens (N=118)
6 0
Infusion-related reaction
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
8 0
Chemotherapy Regimens (N=118)
2 0
Edema peripheral
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
7 0
Chemotherapy Regimens (N=118)
4 <1
Abdominal pain upper
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
7 0
Chemotherapy Regimens (N=118)
3 0
Thrombosis
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
7 3
Chemotherapy Regimens (N=118)
2 2
Hyperglycemia
All Gradesa (%) Grades 3 (%)
Chemotherapy Regimens With Cosela (N=122)
6 2
Chemotherapy Regimens (N=118)
3 0

Laboratory-related adverse reactions reported in this table represent a combined analysis of laboratory parameters and any reported laboratory-related adverse reactions

aGraded per NCI CTCAE v4 .03x

bHypocalcemia=calcium decreased (lab) or treatment-emergent adverse event (TEAE) preferred term 'Hypocalcemia'

cHypokalemia=potassium decreased (lab) or TEAE preferred terms 'Hypokalemia,' 'Blood potassium decreased'

dHypophosphatemia=phosphate decreased (lab) or TEAE preferred terms 'Hypophosphatemia,' 'Blood phosphorus decreased'

eAspartate aminotransferase increased=aspartate aminotransferase increased (lab) or TEAE preferred term 'Blood aspartate aminotransferase increased'

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).