Showed event-free and overall survival rates of 65.5% and 91.5%, respectively
14.2% of patients treated with Sprycel induction therapy received stem cell transplant in first remission
PRINCETON, NJ, USA I December 9, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) today announced data from the phase 2 CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) treated with Sprycel (dasatinib) added to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone. The combination demonstrated an event-free survival (EFS) rate, the study’s primary endpoint, of 65.5% (95% CI: 57.7 to 73.7), and an overall survival (OS) rate of 91.5% (95% CI: 84.2 to 95.5) at three years. Sprycel and chemotherapy were generally well-tolerated in pediatric Ph+ ALL patients. Results will be presented today during an oral session (Abstract #98) at the 2017 American Society of Hematology Annual Meeting in Atlanta, Georgia.
“Philadelphia chromosome-positive acute lymphoblastic leukemia remains a high-risk leukemia type,” said Stephen Hunger, MD, lead study author, Chief of the Division of Oncology and Director of the Center for Childhood Cancer Research at Children’s Hospital of Philadelphia. “In this study, the addition of dasatinib to chemotherapy in pediatric patients with Ph+ ALL yielded similar event-free and overall survival rates to recent North American and European pediatric Ph+ ALL trials, with a lower percentage of patients undergoing hematopoietic stem cell transplantation in first remission, indicating the potential of dasatinib as a new treatment option for these patients.”
Patients treated in the study (n=106), all aged younger than 18 years, received continuous daily Sprycel beginning at day 15 of induction chemotherapy. All treated patients achieved complete remission. Patients who had evidence of minimal residual disease (MRD) ≥0.05% at the end of the first block of treatment (day 78), and those with MRD 0.005% to 0.05% who remained MRD-positive at any detectable level after three additional high-risk chemotherapy blocks, were eligible for hematopoietic stem cell transplantation (HSCT) in first remission. Among treated patients, 19 met this criteria, and 15 (14.2%) received HSCT. The remaining 85.8% of patients received Sprycel plus chemotherapy for two years.
“Ph+ ALL is known to have poorer outcomes than other ALL subtypes in both adults and children, and the availability of treatment options is limited, particularly for young patients,” said Jonathan Leith, Ph.D., hematology development lead, Bristol-Myers Squibb. “For more than a decade Sprycel has been an important treatment option for adults with Ph+ ALL, and these data help advance our understanding of its potential in pediatric patients.”
Study CA180-372
In the ongoing CA180-372 (NCT01460160) study, patients received Sprycel 60 mg/m2 tablets or powder for oral suspension, once daily, in addition to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone for two years or until the occurrence of unacceptable toxicity.
Two patients discontinued Sprycel due to toxicity, one due to allergy and one due to prolonged thrombocytopenia. Primary toxicities of any causality included hematological toxicity such as grade 3 or 4 febrile neutropenia (75.5%), sepsis (23.6%) and bacteremia (24.5%). Non-hematologic, non-infectious grade 3 or 4 adverse events (AEs) attributed to Sprycel and reported in more than 10% of patients were limited to elevated alanine aminotransferase (21.7%) and aspartate transaminase (10.4%). Other grade 3 or 4 AEs attributed to Sprycel were pleural effusion (3.8%), edema (2.8%), hemorrhage (5.7%) and cardiac failure (0.8%). No events of pulmonary hypertension or pulmonary arterial hypertension were reported. Seven deaths occurred during protocol therapy, with five patients receiving chemotherapy (three due to sepsis, one due to pneumonia and one with unknown cause) and two, transplant-related.
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, and in November 2017, Sprycel received FDA approval for the expanded indication for treatment in pediatric patients with CP Ph+ CML. The adult indication is approved in more than 50 countries.
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.
- Pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
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: 14
Showed event-free and overall survival rates of 65.5% and 91.5%, respectively
14.2% of patients treated with Sprycel induction therapy received stem cell transplant in first remission
PRINCETON, NJ, USA I December 9, 2017 I Bristol-Myers Squibb Company (NYSE:BMY) today announced data from the phase 2 CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) treated with Sprycel (dasatinib) added to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone. The combination demonstrated an event-free survival (EFS) rate, the study’s primary endpoint, of 65.5% (95% CI: 57.7 to 73.7), and an overall survival (OS) rate of 91.5% (95% CI: 84.2 to 95.5) at three years. Sprycel and chemotherapy were generally well-tolerated in pediatric Ph+ ALL patients. Results will be presented today during an oral session (Abstract #98) at the 2017 American Society of Hematology Annual Meeting in Atlanta, Georgia.
“Philadelphia chromosome-positive acute lymphoblastic leukemia remains a high-risk leukemia type,” said Stephen Hunger, MD, lead study author, Chief of the Division of Oncology and Director of the Center for Childhood Cancer Research at Children’s Hospital of Philadelphia. “In this study, the addition of dasatinib to chemotherapy in pediatric patients with Ph+ ALL yielded similar event-free and overall survival rates to recent North American and European pediatric Ph+ ALL trials, with a lower percentage of patients undergoing hematopoietic stem cell transplantation in first remission, indicating the potential of dasatinib as a new treatment option for these patients.”
Patients treated in the study (n=106), all aged younger than 18 years, received continuous daily Sprycel beginning at day 15 of induction chemotherapy. All treated patients achieved complete remission. Patients who had evidence of minimal residual disease (MRD) ≥0.05% at the end of the first block of treatment (day 78), and those with MRD 0.005% to 0.05% who remained MRD-positive at any detectable level after three additional high-risk chemotherapy blocks, were eligible for hematopoietic stem cell transplantation (HSCT) in first remission. Among treated patients, 19 met this criteria, and 15 (14.2%) received HSCT. The remaining 85.8% of patients received Sprycel plus chemotherapy for two years.
“Ph+ ALL is known to have poorer outcomes than other ALL subtypes in both adults and children, and the availability of treatment options is limited, particularly for young patients,” said Jonathan Leith, Ph.D., hematology development lead, Bristol-Myers Squibb. “For more than a decade Sprycel has been an important treatment option for adults with Ph+ ALL, and these data help advance our understanding of its potential in pediatric patients.”
Study CA180-372
In the ongoing CA180-372 (NCT01460160) study, patients received Sprycel 60 mg/m2 tablets or powder for oral suspension, once daily, in addition to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone for two years or until the occurrence of unacceptable toxicity.
Two patients discontinued Sprycel due to toxicity, one due to allergy and one due to prolonged thrombocytopenia. Primary toxicities of any causality included hematological toxicity such as grade 3 or 4 febrile neutropenia (75.5%), sepsis (23.6%) and bacteremia (24.5%). Non-hematologic, non-infectious grade 3 or 4 adverse events (AEs) attributed to Sprycel and reported in more than 10% of patients were limited to elevated alanine aminotransferase (21.7%) and aspartate transaminase (10.4%). Other grade 3 or 4 AEs attributed to Sprycel were pleural effusion (3.8%), edema (2.8%), hemorrhage (5.7%) and cardiac failure (0.8%). No events of pulmonary hypertension or pulmonary arterial hypertension were reported. Seven deaths occurred during protocol therapy, with five patients receiving chemotherapy (three due to sepsis, one due to pneumonia and one with unknown cause) and two, transplant-related.
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, and in November 2017, Sprycel received FDA approval for the expanded indication for treatment in pediatric patients with CP Ph+ CML. The adult indication is approved in more than 50 countries.
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.
- Pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
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: 14
