Full Efficacy & Safety Summary Table
| Indication | Prophylactic approach to reduce chemotherapy induced myelosuppression in 1L ES-SCLC patients (eg, prior to receiving a platinum/etoposide containing regimen or a topotecan containing regimen) |
| Registrational Trial | Full Approval. Phase 2 (n=107) vs. EPA alone (NCT02499770) |
| Regimen | 240 mg/m2 per dose, administer 30-minute IV infusion completed within 4 hours prior to start of chemotherapy on each day chemotherapy is administered |
| Efficacy Outcomes | •Reduction of Severe Neutropenia: from 49% to 2% •Reduced mean duration of Severe Neutropenia in Cycle 1: from 4 days to 0 days •Reduced Grade ¾ Anemia: from 28% to 19% •Reduced Carboplatin & Etoposide dose reduction %: from 25% to 2% (carboplatin) // from 26% to 6% (etoposide) |
| Safety Outcomes | Increase in Grade 3/4 ARs vs. Chemo of ≥2%: •Hyposphatemia: +5% •Hypokalemia: +3% •Hyperglycemia: +2% Total Gr ¾ Aes for Cosela + Chemo vs. Chemo only: 31% vs 19% |