EFFICACY AND SAFETY OF IMATINIB GENERICS; A REPORT FROM POLISH (PALG) IMATINIB GENERICS REGISTRY
(Abstract release date: 05/19/16)
EHA Library. Sacha T. 06/11/16; 135188; S432
Assoc. Prof. Tomasz Sacha
Contributions
Contributions
Abstract
Abstract: S432
Type: Oral Presentation
Presentation during EHA21: On Saturday, June 11, 2016 from 11:30 - 11:45
Location: Hall A2
Background
Imatinib generics could substantially decrease costs of CML therapy, however there is a lack of data regarding the efficacy and safety of its use in larger populations of CML patients.
Aims
The aim of the study was to evaluate the efficacy and safety of imatinib generics in patients suffering from chronic phase CML treated de novo with generics („de novo” patients), and in the group of patients switched from glivec to imatinib generics („switched” patients) during a one-year therapy period.
Methods
In „de novo” group the rate of BCR/ABL1 reduction to < 10% at 3 months and to < 1% at 6 months of therapy, the rate of optimal response, and failure according to current ELN guidelines, the rate of CCyR,MMR,MR4, and MR4,5 achieved at 12 months of therapy, and the rate of patients switched to second generation TKI have been assessed. In the „switched” group the rate of sustained, improved and worsened molecular response, the rate of CCyR, MMR, MR4, and MR4,5 loss have been estimated. To assess the safety of imatinib generics in both groups the rate of hematologic (3rd or 4th grade), and of non-hematologic adverse events (all grades according to CTCAE criteria) have been evaluated. In current report the results of one-year, “real-life” observation started on 03.APR.2014 in 501 patients treated in 12 Polish Hematology Centers are presented. Polish Adult Leukemia Group imatinib generics registry records approximately 900 patients, in the current report only patients who completed 12-month observation (all patients with available RQ-PCR result at 12 month), with MMR achieved before start of therapy with generics, and treated for more than 12 months with generics („switched” patients) have been analyzed.
Results
Forty patients started de novo treatment with generics (24 Nibix, 16 Meaxin), and 461 patients were switched from Glivec to imatinib generics (343 to Nibix, 118 to Meaxin). Early molecular response (BCR/ABL1 < 10% at 3 months) was achieved in 75%, and the reduction of BCR/ABL1 to < 1% at 6 months in 68% of „de novo” patients. Optimal response (MMR at 12 months) was achieved in 75% of „de novo” patients. Two patient from this group were switched to 2GTKI due to simultaneously occurred resistance and non-hematological toxicity. Hematologic toxicity (grade 3 or 4) was observed in 2 patients (therapy was not changed), non-hematologic toxicity occurred in 17 patients (2 patients were switched to 2GTKI). In the „switched” group the molecular response under therapy with generics was sustained, improved and worsened in 47.0%, 27.3%, and 25.5% of patients respectively. MMR was lost in 2.4%, CCyR in 0.4% and MR4.5 in 4.5% of patients switched to imatinib generics. During a one-year observation 4.5% of patients were switched to 2GTKI; 3,8% for intolerance (non-haematologic toxicity only), 0.8% for resistance, and 0.6% for intolerance + resistance.
Conclusion
This is the first report on “real life” imatinib generics effectiveness and safety in a big cohort of CML patients. Two tested generics of imatinib (Meaxin and Nibix) seem to be not less effective as Glivec in therapy of patients with CML CP, safety profile of both generics is acceptable – no increased switching rate between 1st and 2GTKI was noted.
Session topic: Chronic myeloid leukemia - Clinical
Keyword(s): Chronic myeloid leukemia, Generic drugs, Imatinib
Type: Oral Presentation
Presentation during EHA21: On Saturday, June 11, 2016 from 11:30 - 11:45
Location: Hall A2
Background
Imatinib generics could substantially decrease costs of CML therapy, however there is a lack of data regarding the efficacy and safety of its use in larger populations of CML patients.
Aims
The aim of the study was to evaluate the efficacy and safety of imatinib generics in patients suffering from chronic phase CML treated de novo with generics („de novo” patients), and in the group of patients switched from glivec to imatinib generics („switched” patients) during a one-year therapy period.
Methods
In „de novo” group the rate of BCR/ABL1 reduction to < 10% at 3 months and to < 1% at 6 months of therapy, the rate of optimal response, and failure according to current ELN guidelines, the rate of CCyR,MMR,MR4, and MR4,5 achieved at 12 months of therapy, and the rate of patients switched to second generation TKI have been assessed. In the „switched” group the rate of sustained, improved and worsened molecular response, the rate of CCyR, MMR, MR4, and MR4,5 loss have been estimated. To assess the safety of imatinib generics in both groups the rate of hematologic (3rd or 4th grade), and of non-hematologic adverse events (all grades according to CTCAE criteria) have been evaluated. In current report the results of one-year, “real-life” observation started on 03.APR.2014 in 501 patients treated in 12 Polish Hematology Centers are presented. Polish Adult Leukemia Group imatinib generics registry records approximately 900 patients, in the current report only patients who completed 12-month observation (all patients with available RQ-PCR result at 12 month), with MMR achieved before start of therapy with generics, and treated for more than 12 months with generics („switched” patients) have been analyzed.
Results
Forty patients started de novo treatment with generics (24 Nibix, 16 Meaxin), and 461 patients were switched from Glivec to imatinib generics (343 to Nibix, 118 to Meaxin). Early molecular response (BCR/ABL1 < 10% at 3 months) was achieved in 75%, and the reduction of BCR/ABL1 to < 1% at 6 months in 68% of „de novo” patients. Optimal response (MMR at 12 months) was achieved in 75% of „de novo” patients. Two patient from this group were switched to 2GTKI due to simultaneously occurred resistance and non-hematological toxicity. Hematologic toxicity (grade 3 or 4) was observed in 2 patients (therapy was not changed), non-hematologic toxicity occurred in 17 patients (2 patients were switched to 2GTKI). In the „switched” group the molecular response under therapy with generics was sustained, improved and worsened in 47.0%, 27.3%, and 25.5% of patients respectively. MMR was lost in 2.4%, CCyR in 0.4% and MR4.5 in 4.5% of patients switched to imatinib generics. During a one-year observation 4.5% of patients were switched to 2GTKI; 3,8% for intolerance (non-haematologic toxicity only), 0.8% for resistance, and 0.6% for intolerance + resistance.
Conclusion
This is the first report on “real life” imatinib generics effectiveness and safety in a big cohort of CML patients. Two tested generics of imatinib (Meaxin and Nibix) seem to be not less effective as Glivec in therapy of patients with CML CP, safety profile of both generics is acceptable – no increased switching rate between 1st and 2GTKI was noted.
Session topic: Chronic myeloid leukemia - Clinical
Keyword(s): Chronic myeloid leukemia, Generic drugs, Imatinib
Abstract: S432
Type: Oral Presentation
Presentation during EHA21: On Saturday, June 11, 2016 from 11:30 - 11:45
Location: Hall A2
Background
Imatinib generics could substantially decrease costs of CML therapy, however there is a lack of data regarding the efficacy and safety of its use in larger populations of CML patients.
Aims
The aim of the study was to evaluate the efficacy and safety of imatinib generics in patients suffering from chronic phase CML treated de novo with generics („de novo” patients), and in the group of patients switched from glivec to imatinib generics („switched” patients) during a one-year therapy period.
Methods
In „de novo” group the rate of BCR/ABL1 reduction to < 10% at 3 months and to < 1% at 6 months of therapy, the rate of optimal response, and failure according to current ELN guidelines, the rate of CCyR,MMR,MR4, and MR4,5 achieved at 12 months of therapy, and the rate of patients switched to second generation TKI have been assessed. In the „switched” group the rate of sustained, improved and worsened molecular response, the rate of CCyR, MMR, MR4, and MR4,5 loss have been estimated. To assess the safety of imatinib generics in both groups the rate of hematologic (3rd or 4th grade), and of non-hematologic adverse events (all grades according to CTCAE criteria) have been evaluated. In current report the results of one-year, “real-life” observation started on 03.APR.2014 in 501 patients treated in 12 Polish Hematology Centers are presented. Polish Adult Leukemia Group imatinib generics registry records approximately 900 patients, in the current report only patients who completed 12-month observation (all patients with available RQ-PCR result at 12 month), with MMR achieved before start of therapy with generics, and treated for more than 12 months with generics („switched” patients) have been analyzed.
Results
Forty patients started de novo treatment with generics (24 Nibix, 16 Meaxin), and 461 patients were switched from Glivec to imatinib generics (343 to Nibix, 118 to Meaxin). Early molecular response (BCR/ABL1 < 10% at 3 months) was achieved in 75%, and the reduction of BCR/ABL1 to < 1% at 6 months in 68% of „de novo” patients. Optimal response (MMR at 12 months) was achieved in 75% of „de novo” patients. Two patient from this group were switched to 2GTKI due to simultaneously occurred resistance and non-hematological toxicity. Hematologic toxicity (grade 3 or 4) was observed in 2 patients (therapy was not changed), non-hematologic toxicity occurred in 17 patients (2 patients were switched to 2GTKI). In the „switched” group the molecular response under therapy with generics was sustained, improved and worsened in 47.0%, 27.3%, and 25.5% of patients respectively. MMR was lost in 2.4%, CCyR in 0.4% and MR4.5 in 4.5% of patients switched to imatinib generics. During a one-year observation 4.5% of patients were switched to 2GTKI; 3,8% for intolerance (non-haematologic toxicity only), 0.8% for resistance, and 0.6% for intolerance + resistance.
Conclusion
This is the first report on “real life” imatinib generics effectiveness and safety in a big cohort of CML patients. Two tested generics of imatinib (Meaxin and Nibix) seem to be not less effective as Glivec in therapy of patients with CML CP, safety profile of both generics is acceptable – no increased switching rate between 1st and 2GTKI was noted.
Session topic: Chronic myeloid leukemia - Clinical
Keyword(s): Chronic myeloid leukemia, Generic drugs, Imatinib
Type: Oral Presentation
Presentation during EHA21: On Saturday, June 11, 2016 from 11:30 - 11:45
Location: Hall A2
Background
Imatinib generics could substantially decrease costs of CML therapy, however there is a lack of data regarding the efficacy and safety of its use in larger populations of CML patients.
Aims
The aim of the study was to evaluate the efficacy and safety of imatinib generics in patients suffering from chronic phase CML treated de novo with generics („de novo” patients), and in the group of patients switched from glivec to imatinib generics („switched” patients) during a one-year therapy period.
Methods
In „de novo” group the rate of BCR/ABL1 reduction to < 10% at 3 months and to < 1% at 6 months of therapy, the rate of optimal response, and failure according to current ELN guidelines, the rate of CCyR,MMR,MR4, and MR4,5 achieved at 12 months of therapy, and the rate of patients switched to second generation TKI have been assessed. In the „switched” group the rate of sustained, improved and worsened molecular response, the rate of CCyR, MMR, MR4, and MR4,5 loss have been estimated. To assess the safety of imatinib generics in both groups the rate of hematologic (3rd or 4th grade), and of non-hematologic adverse events (all grades according to CTCAE criteria) have been evaluated. In current report the results of one-year, “real-life” observation started on 03.APR.2014 in 501 patients treated in 12 Polish Hematology Centers are presented. Polish Adult Leukemia Group imatinib generics registry records approximately 900 patients, in the current report only patients who completed 12-month observation (all patients with available RQ-PCR result at 12 month), with MMR achieved before start of therapy with generics, and treated for more than 12 months with generics („switched” patients) have been analyzed.
Results
Forty patients started de novo treatment with generics (24 Nibix, 16 Meaxin), and 461 patients were switched from Glivec to imatinib generics (343 to Nibix, 118 to Meaxin). Early molecular response (BCR/ABL1 < 10% at 3 months) was achieved in 75%, and the reduction of BCR/ABL1 to < 1% at 6 months in 68% of „de novo” patients. Optimal response (MMR at 12 months) was achieved in 75% of „de novo” patients. Two patient from this group were switched to 2GTKI due to simultaneously occurred resistance and non-hematological toxicity. Hematologic toxicity (grade 3 or 4) was observed in 2 patients (therapy was not changed), non-hematologic toxicity occurred in 17 patients (2 patients were switched to 2GTKI). In the „switched” group the molecular response under therapy with generics was sustained, improved and worsened in 47.0%, 27.3%, and 25.5% of patients respectively. MMR was lost in 2.4%, CCyR in 0.4% and MR4.5 in 4.5% of patients switched to imatinib generics. During a one-year observation 4.5% of patients were switched to 2GTKI; 3,8% for intolerance (non-haematologic toxicity only), 0.8% for resistance, and 0.6% for intolerance + resistance.
Conclusion
This is the first report on “real life” imatinib generics effectiveness and safety in a big cohort of CML patients. Two tested generics of imatinib (Meaxin and Nibix) seem to be not less effective as Glivec in therapy of patients with CML CP, safety profile of both generics is acceptable – no increased switching rate between 1st and 2GTKI was noted.
Session topic: Chronic myeloid leukemia - Clinical
Keyword(s): Chronic myeloid leukemia, Generic drugs, Imatinib
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