Bristol-Myers Squibb (BMS) has published the results of an observational study SIMPLICITY, which confirmed that Sprycel maintained efficacy for longer periods at standard doses than nilotinib as the first-line treatment of chronic myeloid leukemia.
|BMS' chronic myeloid leukemia treatment Sprycel|
Sprycel is a second-generation tyrosine kinase inhibitor (TKI) taken once daily with or without a meal.
The drug received approval from the Ministry of Food and Drug Safety as the second-line treatment for patients with chronic myeloid leukemia in January 2007, while the drug’s indication was further expanded to be used as a first-line treatment for newly diagnosed adult patients with chronic myeloid leukemia in January 2011.
The drug also received approval to treat pediatric patients with chronic myeloid leukemia in March last year.
Professor Michael Mauro at Memorial Sloan Kettering Cancer Center presented the trial data at the International Association for Comparative Research on Leukemia and Related Diseases (IACRLRD) 2019, in Seoul.
The SIMPLICITY study has been underway since 2010 to evaluate the TKI in patients with chronic myeloid leukemia in Europe and the U.S.
To analyze the dose patterns and predictors of dose reduction, the research team administered 100mg of Sprycel daily to 405 patients, or 300mg or 400mg nilotinib twice-a-day to 350 patients. Afterwards, the researchers followed up on the drug intake pattern for five years.
The results showed that the proportion of patients who started their first-line treatment at the standard dose was significantly higher in the Sprycel group when compared with the nilotinib group.
The majority of Sprycel-treated group, 92.1 percent, was able to start their treatment with a standard dose of 100mg, while 70.1 percent of the nilotinib-administered group started their treatment with a standard dose of 300mg. Another 13.6 percent started with 400mg nilotinib, which is the approved amount for patients using the drug as a second-line treatment.
The study also showed the median time to dose reduction median longer in the Sprycel 100mg group (139.5 days) than in the nilotinib 300mg (84 days) or 400mg (80.5 days) group.
Also, in patients receiving dose reductions, the median duration of therapy (DoT) was significantly longer for those starting on Sprycel 100mg (47.5 months), versus those starting on nilotinib 400mg (26.2 months).
“Chronic myeloid leukemia requires long-term management, and it is important to maintain proper treatment according to the dosage and regimen,” Mauro said. “The study showed that the duration of treatment for patients with reduced doses was longer in the Sprycel group than in the nilotinib group, which will help medical staff select and optimize the dosage in the clinical setting.”