Bristol-Myers Squibb Co. reported positive results from an ongoing phase 2 trial evaluating Sprycel in patients aged 18 years or younger with newly diagnosed chronic myeloid leukemia or Philadelphia chromosome-positive leukemias resistant to or intolerant of imatinib.
The trial met the primary endpoints for each patient group. Patients resistant to or intolerant of imatinib who received Sprycel demonstrated a cumulative major cytogenetic response rate of 55.2% three months into treatment, exceeding the defined threshold of clinical interest of more than 30% for the primary endpoint of the cohort and increasing over time to greater than 90% at 24 months.
Newly diagnosed patients achieved a cumulative complete cytogenetic response rate, the primary endpoint in the cohort, of 64% as early as six months into treatment, exceeding the defined threshold of clinical interest more than 55% and increasing over time to 94% at 24 months.
The secondary endpoint of estimated progression-free survival at 48 months was greater than 75% for patients resistant to or intolerant of imatinib and greater than 90% for patients newly diagnosed with the disease.
Sprycel was approved by the U.S. Food and Drug Administration in 2006 for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase who are resistant or intolerant to prior therapy including imatinib. It is also an FDA-approved treatment in adult patients with Philadelphia chromosome-positive lymphoblastic leukemia who are resistant or intolerant to prior therapy.
Sprycel is approved and marketed worldwide for these indications in more than 60 countries.