Target responses were sustained over time in newly diagnosed and imatinib-resistant or -intolerant pediatric patients and treatment safety profile was comparable to that in adult patients
Largest prospective trial in pediatric chronic myeloid leukemia in chronic phase includes first formulation specifically developed for pediatric population
PRINCETON, NJ, USA I June 5, 2017 I Bristol-Myers Squibb Company (NYSE: BMY) today announced the first presentation of data from two cohorts of the Phase 2 CA180-226 clinical trial evaluating Sprycel (dasatinib) in imatinib-resistant or -intolerant (R/I to IM) and newly diagnosed (ND) pediatric patients with chronic phase chronic myeloid leukemia.
At minimum two-year follow-up, patients with CP-CML resistant to or intolerant of imatinib who received Sprycel demonstrated a cumulative major cytogenetic response (MCyR) rate of 55.2% (95% CI: 36, 74) 3 months into treatment, exceeding the defined threshold of clinical interest (>30%) for the primary endpoint of the cohort and increasing over time to greater than 90% (95% CI: 73, 98) at 24 months. Newly diagnosed patients with CP-CML, who received Sprycel orally or as powder for oral suspension (PFOS) once daily, achieved a cumulative complete cytogenetic response (CCyR) rate, the primary endpoint in the cohort, of 64% (95% CI: 53, 74) as early as 6 months into treatment, exceeding the defined threshold of clinical interest (>55%) and increasing over time to 94% (95% CI: 87, 98) at 24 months. The median durations of response were not estimable, or not yet reached, in each cohort at the time of follow-up (95% CI, R/I to IM: NE [54.9, NE]; ND: NE [49.9, NE]).
The secondary endpoint of estimated progression-free survival (PFS) at 48 months was greater than 75% for patients resistant to or intolerant of imatinib and greater than 90% for patients newly diagnosed with CP-CML. Sprycel was shown to have a comparable safety profile in pediatric patients with CP-CML to that reported in adults with CP-CML. In this study, there were no reported events of pleural/pericardial effusion, pulmonary edema/hypertension or pulmonary arterial hypertension related to Sprycel.
“Treatments for children and adolescents with newly diagnosed CML in chronic phase are limited, and even more so for those resistant to or intolerant of imatinib,” said Lia Gore, MD, University of Colorado School of Medicine and Children’s Hospital of Colorado. “The time to and duration of responses along with the safety profile for patients studied suggest dasatinib could become an important option for pediatric patients with chronic phase CML.”
These data will be presented today in the Pediatric Oncology II Oral Session from 8:24 to 8:36 a.m. CDT during the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 in Chicago.
“Chronic myeloid leukemia in pediatric patients is rare, making it difficult to study, and is often more aggressive in children and young adults,” said Jonathan Leith, PhD, hematology development lead, Bristol-Myers Squibb. “As part of our commitment to advance new treatment options for pediatric cancer patients, this study was designed to evaluate the potential for Sprycel to address unmet needs for those with chronic phase CML, including a formulation developed specifically for children. The results demonstrate promising efficacy and safety in the first- and second-line settings.”
Study CA180-226
CA180-226 is an ongoing Phase 2, open-label, nonrandomized study evaluating Sprycel in patients aged 18 years or younger with newly diagnosed chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) leukemias resistant to or intolerant of imatinib. Cohorts 1 and 3 examined 29 CP-CML pediatric patients resistant to or intolerant of imatinib and 84 pediatric patients with newly diagnosed CML in chronic phase (CP), respectively. Cohort 2 evaluated Sprycel in pediatric patients with accelerated/blast phase CML or Philadelphia chromosome-positive acute lymphoblastic leukemia.
Patients newly diagnosed with CP-CML received either Sprycel 60 mg/m2 tablets orally, once daily, or 72 mg/m2 Sprycel powder for oral suspension (PFOS) once daily, and patients with CP-CML resistant to or intolerant of imatinib received Sprycel tablets 60 mg/m2 orally, once daily.
One patient had a Sprycel-related AE leading to discontinuation, and one patient died from gastrointestinal bleeding unrelated to treatment. The most commonly reported AEs in newly diagnosed patients treated with Sprycel were nausea/vomiting (20%), rash (19%) and diarrhea (18%), and in imatinib-intolerant or -resistant patients were nausea/vomiting (31%), myalgia/arthralgia (17%), fatigue (14%) and rash (14%).
About Sprycel
Sprycel first received FDA approval in 2006 for the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) who are resistant or intolerant to prior therapy including imatinib. At that time, Sprycel was also approved for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to prior therapy. Sprycel is approved and marketed worldwide for these indications in more than 60 countries.
Sprycel is also an FDA-approved treatment for adults with newly diagnosed CP Ph+ CML (since October 2010). Sprycel received accelerated FDA approval for this indication. Additional country approvals for this indication total more than 50.
U.S. FDA-APPROVED INDICATIONS FOR SPRYCEL ®
SPRYCEL® (dasatinib) is indicated for the treatment of adults with:
- Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
- Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
- Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
Please see the full Prescribing Information for SPRYCEL.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
SOURCE: Bristol-Myers Squibb
Post Views: 23
Target responses were sustained over time in newly diagnosed and imatinib-resistant or -intolerant pediatric patients and treatment safety profile was comparable to that in adult patients
Largest prospective trial in pediatric chronic myeloid leukemia in chronic phase includes first formulation specifically developed for pediatric population
PRINCETON, NJ, USA I June 5, 2017 I Bristol-Myers Squibb Company (NYSE: BMY) today announced the first presentation of data from two cohorts of the Phase 2 CA180-226 clinical trial evaluating Sprycel (dasatinib) in imatinib-resistant or -intolerant (R/I to IM) and newly diagnosed (ND) pediatric patients with chronic phase chronic myeloid leukemia.
At minimum two-year follow-up, patients with CP-CML resistant to or intolerant of imatinib who received Sprycel demonstrated a cumulative major cytogenetic response (MCyR) rate of 55.2% (95% CI: 36, 74) 3 months into treatment, exceeding the defined threshold of clinical interest (>30%) for the primary endpoint of the cohort and increasing over time to greater than 90% (95% CI: 73, 98) at 24 months. Newly diagnosed patients with CP-CML, who received Sprycel orally or as powder for oral suspension (PFOS) once daily, achieved a cumulative complete cytogenetic response (CCyR) rate, the primary endpoint in the cohort, of 64% (95% CI: 53, 74) as early as 6 months into treatment, exceeding the defined threshold of clinical interest (>55%) and increasing over time to 94% (95% CI: 87, 98) at 24 months. The median durations of response were not estimable, or not yet reached, in each cohort at the time of follow-up (95% CI, R/I to IM: NE [54.9, NE]; ND: NE [49.9, NE]).
The secondary endpoint of estimated progression-free survival (PFS) at 48 months was greater than 75% for patients resistant to or intolerant of imatinib and greater than 90% for patients newly diagnosed with CP-CML. Sprycel was shown to have a comparable safety profile in pediatric patients with CP-CML to that reported in adults with CP-CML. In this study, there were no reported events of pleural/pericardial effusion, pulmonary edema/hypertension or pulmonary arterial hypertension related to Sprycel.
“Treatments for children and adolescents with newly diagnosed CML in chronic phase are limited, and even more so for those resistant to or intolerant of imatinib,” said Lia Gore, MD, University of Colorado School of Medicine and Children’s Hospital of Colorado. “The time to and duration of responses along with the safety profile for patients studied suggest dasatinib could become an important option for pediatric patients with chronic phase CML.”
These data will be presented today in the Pediatric Oncology II Oral Session from 8:24 to 8:36 a.m. CDT during the American Society of Clinical Oncology (ASCO) Annual Meeting 2017 in Chicago.
“Chronic myeloid leukemia in pediatric patients is rare, making it difficult to study, and is often more aggressive in children and young adults,” said Jonathan Leith, PhD, hematology development lead, Bristol-Myers Squibb. “As part of our commitment to advance new treatment options for pediatric cancer patients, this study was designed to evaluate the potential for Sprycel to address unmet needs for those with chronic phase CML, including a formulation developed specifically for children. The results demonstrate promising efficacy and safety in the first- and second-line settings.”
Study CA180-226
CA180-226 is an ongoing Phase 2, open-label, nonrandomized study evaluating Sprycel in patients aged 18 years or younger with newly diagnosed chronic myeloid leukemia (CML) or Philadelphia chromosome-positive (Ph+) leukemias resistant to or intolerant of imatinib. Cohorts 1 and 3 examined 29 CP-CML pediatric patients resistant to or intolerant of imatinib and 84 pediatric patients with newly diagnosed CML in chronic phase (CP), respectively. Cohort 2 evaluated Sprycel in pediatric patients with accelerated/blast phase CML or Philadelphia chromosome-positive acute lymphoblastic leukemia.
Patients newly diagnosed with CP-CML received either Sprycel 60 mg/m2 tablets orally, once daily, or 72 mg/m2 Sprycel powder for oral suspension (PFOS) once daily, and patients with CP-CML resistant to or intolerant of imatinib received Sprycel tablets 60 mg/m2 orally, once daily.
One patient had a Sprycel-related AE leading to discontinuation, and one patient died from gastrointestinal bleeding unrelated to treatment. The most commonly reported AEs in newly diagnosed patients treated with Sprycel were nausea/vomiting (20%), rash (19%) and diarrhea (18%), and in imatinib-intolerant or -resistant patients were nausea/vomiting (31%), myalgia/arthralgia (17%), fatigue (14%) and rash (14%).
About Sprycel
Sprycel first received FDA approval in 2006 for the treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) who are resistant or intolerant to prior therapy including imatinib. At that time, Sprycel was also approved for adults with Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to prior therapy. Sprycel is approved and marketed worldwide for these indications in more than 60 countries.
Sprycel is also an FDA-approved treatment for adults with newly diagnosed CP Ph+ CML (since October 2010). Sprycel received accelerated FDA approval for this indication. Additional country approvals for this indication total more than 50.
U.S. FDA-APPROVED INDICATIONS FOR SPRYCEL ®
SPRYCEL® (dasatinib) is indicated for the treatment of adults with:
- Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
- Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
- Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
Please see the full Prescribing Information for SPRYCEL.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
SOURCE: Bristol-Myers Squibb
Post Views: 23
