Sapacitabine Fails to Meet Primary Endpoint in Clinical Trial of Older AML Patients

In a clinical trial of older patients with acute myeloid leukemia (AML), the experimental oral leukemia drug sapacitabine failed to meet its primary endpoint of statistically significant improvement in overall survival (OS).

The randomized, phase III SEAMLESS study enrolled patients with AML who were ≥70 years old and  “unfit” for intensive induction chemotherapy, or who refused the treatment. Patients were randomized to receive oral sapacitabine (also known as CYC682) in alternate cycles with intravenous (IV) decitabine or IV decitabine alone.

Cyclacel, the drug’s manufacturer, reported, however, that there was a trend in improvement in complete remission rates among sapacitabine-treated patients (a secondary endpoint of the study).  They also noted that they will discuss the next steps in the approval process with European and U.S. regulatory authorities, including data from yet-to-be-completed subgroup analyses.

Sapacitabine was designated as an orphan drug for the treatment of AML and MDS by both the U.S. Food and Drug Administration and European Medicines Agency. Other planned phase II studies will evaluate sapacitabine for the treatment of patients with myelodysplastic syndromes, cutaneous T-cell lymphoma, and non-small cell lung cancer.

Source: Cyclacel press release, February 23, 2017.