Bristol-Myers Squibb’s (BMY) Sprycel is used for the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase and Philadelphia chromosome-positive acute lymphoblastic leukemia (or ALL) who are resistant or were not tolerant of previous therapies.
Sprycel first received U.S. Food and Drug Administration approval in 2006 for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (or CML) in chronic phase who were resistant or did not adequately tolerate previous therapy including imatinib. In 1Q17, 2Q17, and 3Q17, Sprycel generated revenues of $463 million, $506 million, and $509 million, respectively.
In December 2017, Bristol-Myers Squibb presented new data from the phase 2 CA180-372 trial. The trial evaluated the safety and efficacy of Sprycel in addition to chemotherapy in pediatric patients with newly diagnosed Philadelphia chromosome-positive ALL.
Sprycel and chemotherapy demonstrated an event-free survival (or EFS) rate of 65.5%, which was also the primary endpoint of the clinical trial. Sprycel in combination with chemotherapy demonstrated an overall survival (or OS) of 91.5% at three years.
In the clinical trial, all patients under 18 years received constant daily Sprycel starting at day 15 of chemotherapy. All patients on Sprycel achieved complete remission. At the end of the first block of treatment (or day 78), patients who demonstrated evidence of minimal residual disease (or MRD) greater than 0.05% and patients demonstrating MRD between 0.005% and 0.05% after three additional blocks of high-risk chemotherapy were eligible for HSCT (hematopoietic stem cell transplantation) in first remission. Among all patients in the trial, 19 met this criterion and underwent HSCT, while the rest received Sprycel and chemotherapy combination for two years.
Success in the clinical trial is expected to further strengthen commercialization capabilities, and data generated from the trial could help label expansion of Sprycel. The National Cancer Institute’s Surveillance, Epidemiology, and End Results (or SEER) Program estimated 8,950 new incidences of CML and 1,080 deaths due to CML in the United States. SEER also estimated that 66.9% of CML patients survive for five years.
Sprycel competes with Novartis’s (NVS) Gleevec and Tasigna, Takeda Pharmaceuticals’ (TKPYY) Iclusig, and Pfizer’s (PFE) Bosulif. In 1Q17, 2Q17, and 3Q17, Novartis’s Gleevec reported revenues of $544 million, $506 million, and $445 million, respectively. The iShares Russell 1000 Value ETF (IWD) invests ~0.41% of its total portfolio holding in Bristol-Myers Squibb.