Evoltra(clofarabine)
Oncology· 97 cited findings· 1 source document
Company: Sanofi →
What the regulatory reviews say
Evoltra (clofarabine) is approved under exceptional circumstances. Clinical trials included a Phase 1/2 study that began on 11 March 2006 and concluded on 25 November 2009 for the last Phase 2 patient, with a data cut-off date of 11 May 2010. The Recommended Phase 2 Dose for clofarabine was 40 mg/m2, and for cyclophosphamide, it was 440 mg/m2.
In Phase 1, the overall response rate was 64.0%, with a median overall survival of 27.1 weeks. The hazard ratio for death in Phase 1 cohorts 1-4 versus the Recommended Phase 2 Dose was 0.668. In Phase 2, the median event-free survival was 10.7 weeks, and 40.0% of patients proceeded to transplant.
Safety findings in Phase 2 showed that 80.0% of patients experienced at least one serious adverse event related to clofarabine. Grade 4 events occurred in 64.0% of patients, and Grade 5 events occurred in 32.0% of patients. Three patients developed veno-occlusive liver disease, and 64.0% of patients died during the Phase 2 study. Early deaths in patients receiving the Recommended Phase 2 Dose were 25.8%.
Key figures — cited to the source page
| Hazard ratio for death (Phase 1 cohorts 1-4 vs RP2D) | 0.668 | Sanofi — Evoltra EMA EPAR variation assessment report (EMEA/, p.9 |
| Overall response rate (Phase 1) | 64.0 | Sanofi — Evoltra EMA EPAR variation assessment report (EMEA/, p.10 |
| Median EFS (Phase 2) | 10.7 | Sanofi — Evoltra EMA EPAR variation assessment report (EMEA/, p.10 |
| Patients proceeding to transplant (Phase 2) | 40.0 | Sanofi — Evoltra EMA EPAR variation assessment report (EMEA/, p.10 |
| Patients with at least 1 SAE related to clofarabine (Phase 2) | 80.0 | Sanofi — Evoltra EMA EPAR variation assessment report (EMEA/, p.10 |
| Patients with Grade 5 event (Phase 2) | 32.0 | Sanofi — Evoltra EMA EPAR variation assessment report (EMEA/, p.11 |
| Early deaths (RP2D patients) | 25.8 | Sanofi — Evoltra EMA EPAR variation assessment report (EMEA/, p.9 |
| Approval status of clofarabine (Evoltra) | approved under exceptional circumstances | Sanofi — Evoltra EMA EPAR variation assessment report (EMEA/, p.2 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.