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CLINICAL NEWS |
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had discontinued treatment ( n = 572 ). Discontinuations were due to PD ( 62.2 %), death ( 7.9 %), and AEs ( 5.9 %).
The median treatment duration was 4.9 months , with a median relative dose intensity ( measured by comparing actual dose intensity with planned dose intensity ) of 0.901 , which the researchers noted “[ indicates ] that treatment was generally well tolerated with a low dose reduction / interruption rate and high treatment compliance .”
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Of the 676 patients evaluable for safety endpoints , the most frequently reported grade 3 / 4 hematologic AEs included neutropenia ( 49.7 %), anemia ( 33 %), and thrombocytopenia ( 24.1 %). Pneumonia of any grade occurred in 111 patients ( 16.4 %), and all but 0.1 percent of those cases were infectious . Serious AEs were observed in 62.9 percent of patients ( n = 425 ), with SPMs reported in 15 patients ( 5 with solid |
tumors and 10 with non-invasive skin cancers ).
Hematologic and non-hematologic AEs tended to occur mostly in early treatment cycles with a diminished frequency afterward , they added . At the time of analysis , 57.7 percent of patients in the safety population had died , the majority ( 68.5 %) after treatment discontinuation . “ The safety profile was consistent with the profile observed in the pivotal
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studies of pomalidomide plus low-dose dexamethasone , and no new safety signals were identified in this large patient population ,” Dr . Dimopoulos and authors noted . “ Similar to the MM-002 and MM-003 studies , the most frequent grade 3 / 4 AEs were hematologic with a low incidence of febrile neutropenia and discontinuations due to AEs were infrequent [ 6 %].”
The efficacy results with pomalidomide plus low-dose dexamethasone
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BOSULIF offers proven efficacy for patients with resistance or intolerance to prior therapy 2
In 2nd-line treatment , after imatinib ( n = 266 evaluable ) a
34 % 53 % of patients of patients achieved MCyR at 6 months ( 95 % CI : 28.2 , 39.9 ) achieved MCyR with a minimum follow-up of 23 months
Median duration of MCyR was not reached at the time of analysis
53 % of patients with MCyR maintained MCyR for at least 18 months ( with a minimum follow-up of 23 months )
In 3rd-line treatment , after imatinib followed by nilotinib and / or dasatinib therapy ( n = 108 evaluable )
• 27 % of patients achieved MCyR by 6 months ( 95 % CI : 18.8 , 36.2 )
• 32 % of patients achieved MCyR with a minimum follow-up of 13 months
• Median duration of MCyR was not reached at the time of analysis — 51 % of patients with MCyR maintained MCyR for at least 9 months ( with a minimum follow-up of 13 months )
BOSULIF has a distinct safety and tolerability profile 2
Warnings and precautions include : gastrointestinal toxicity , myelosuppression , hepatic toxicity , fluid retention , renal toxicity , and embryofetal toxicity . Please see Important Safety Information below for more detail .
Most common adverse reactions observed in ≥20 % of patients in the Phase 1 / 2 safety population ( N = 546 )
All grades (%) Diarrhea ( 82 ) Rash ( 35 )
Nausea ( 46 ) |
Anemia ( 27 ) |
Thrombocytopenia ( 41 ) |
Pyrexia ( 26 ) |
Vomiting ( 39 ) Fatigue ( 24 ) Abdominal pain ( 37 )
For more information on BOSULIF , visit www . BosulifHCP . com .
Most common Grade 3 / 4 adverse reactions observed in ≥10 % of patients
Grade 3 / 4 (%) Thrombocytopenia ( 29 ) Anemia ( 13 ) Neutropenia ( 12 ) a
Median duration of treatment was 22 months for evaluable patients . MCyR = major cytogenetic response .
Embryofetal Toxicity : BOSULIF may cause fetal harm when administered to a pregnant woman . Women of childbearing potential should be advised of potential hazard to the fetus and to avoid becoming pregnant while receiving BOSULIF .
Adverse Reactions : The most common adverse reactions observed in greater than 20 % of patients in the Phase 1 / 2 safety population ( N = 546 ) were diarrhea , nausea , thrombocytopenia , vomiting , abdominal pain , rash , anemia , pyrexia , and fatigue . The most common Grade 3 / 4 adverse reactions and laboratory abnormalities observed in greater than 10 % of patients were thrombocytopenia , anemia , and neutropenia .
CYP3A Inhibitors and Inducers : Avoid concurrent use with strong or moderate CYP3A inhibitors or inducers .
Please see brief summary of full Prescribing Information on the following pages .
Proton Pump Inhibitors : Consider using short-acting antacids or H2 blockers instead of PPIs to avoid a reduction in BOSULIF exposure . Separate antacid or H2 blocker dosing and BOSULIF dosing by more than 2 hours .
Nursing Mothers : Given the potential for serious adverse reactions in nursing infants , a decision should be made whether to discontinue nursing or BOSULIF , taking into account the importance of the drug to the mother .
References : 1 . Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology ( NCCN Guidelines ®) for Chronic Myelogenous Leukemia V . 1.2016 . © National Comprehensive Cancer Network , Inc . 2015 . All rights reserved . Accessed October 27 , 2015 . To view the most recent and complete version of the guideline , go online to NCCN . org . NATIONAL COMPREHENSIVE CANCER NETWORK ®, NCCN ®, NCCN GUIDELINES ®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network , Inc . 2 . BOSULIF Prescribing Information . New York , NY : Pfizer Inc .
PP-BOS-USA-0184-01 © 2016 Pfizer Inc . All rights reserved . May 2016