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).
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