EFFICACY AND SAFETY OF INOTUZUMAB OZOGAMICIN IN OLDER PATIENTS WITH RELAPSED/REFRACTORY ACUTE LYMPHOBLASTIC LEUKEMIA ENROLLED IN THE GLOBAL PHASE 3 RANDOMIZED CONTROLLED INO-VATE TRIAL
(Abstract release date: 05/19/16)
EHA Library. Jabbour E. 06/10/16; 133155; P167
Dr. Elias Jabbour
Contributions
Contributions
Abstract
Abstract: P167
Type: Poster Presentation
Presentation during EHA21: On Friday, June 10, 2016 from 17:15 - 18:45
Location: Poster area (Hall H)
Background
Inotuzumab Ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, has demonstrated superior response vs standard care for relapsed/refractory acute lymphoblastic leukemia (ALL) in the ongoing phase 3 INO-VATE trial (complete remission [CR]/CR with incomplete hematologic recovery [CRi], 81% [95% CI; 72–88]; minimal residual disease [MRD] negativity in responders, 78% [68–87]; median remission duration [DoR], 4.6 [3.9–5.4] months).
Aims
To assess the efficacy and safety of InO in patients with relapsed/refractory ALL aged ≥55 vs <55 years
Methods
Per protocol, the intent-to-treat analyses of CR/CRi included the first 218 of 326 patients randomized (ITT218). The safety population included 139 patients who received ≥1 InO dose (max 1.8 mg/m2/cycle [0.8 mg/m2 on day 1; 0.5 mg/m2 on days 8 and 15 of a 21–28 day cycle for ≤6 cycles]). MRD negativity was assessed by central flow cytometry (<0.01%). Data as of October 2, 2014 are presented (trial ongoing). Informed consent was obtained from all patients.
Results
109 patients in the ITT218 received InO (median age, 47 [range, 18–78] years; patients ≥55 years, 43 [39%]). Remission rates and DoR were similar whereas MRD-negativity rates in responders were numerically higher in older patients (Table). In the safety population, grade ≥3 adverse events (AEs) were most frequently cytopenias (neutropenia, 46%; thrombocytopenia, 37%; febrile neutropenia, 24%); these grade ≥3 AEs were more common in patients ≥55 (n=53) vs <55 years (n=86): thrombocytopenia (49% vs 29%), neutropenia (53% vs 42%), febrile neutropenia (28% vs 21%). Patients ≥55 vs <55 years had similar discontinuation rates due to AEs (both 17%). For patients ≥55 vs <55 years, any grade hepatobiliary AE rates were similar (both 26%) and included, hyperbilirubinemia (both 15%), and veno-occlusive liver disease (VOD) including post-SCT VOD (both 11%; 2 fatal in patients <55 years [1 after second SCT]).
Conclusion
InO was highly effective in older patients with relapsed/refractory ALL for whom treatment options are currently limited; responses and safety profiles were generally similar to younger patients and the overall study population.
Session topic: Acute lymphoblastic leukemia - Clinical 1
Keyword(s): Acute lymphoblastic leukemia, Chemotherapy, Phase III, Relapsed acute lymphoblastic leukemia
Type: Poster Presentation
Presentation during EHA21: On Friday, June 10, 2016 from 17:15 - 18:45
Location: Poster area (Hall H)
Background
Inotuzumab Ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, has demonstrated superior response vs standard care for relapsed/refractory acute lymphoblastic leukemia (ALL) in the ongoing phase 3 INO-VATE trial (complete remission [CR]/CR with incomplete hematologic recovery [CRi], 81% [95% CI; 72–88]; minimal residual disease [MRD] negativity in responders, 78% [68–87]; median remission duration [DoR], 4.6 [3.9–5.4] months).
Aims
To assess the efficacy and safety of InO in patients with relapsed/refractory ALL aged ≥55 vs <55 years
Methods
Per protocol, the intent-to-treat analyses of CR/CRi included the first 218 of 326 patients randomized (ITT218). The safety population included 139 patients who received ≥1 InO dose (max 1.8 mg/m2/cycle [0.8 mg/m2 on day 1; 0.5 mg/m2 on days 8 and 15 of a 21–28 day cycle for ≤6 cycles]). MRD negativity was assessed by central flow cytometry (<0.01%). Data as of October 2, 2014 are presented (trial ongoing). Informed consent was obtained from all patients.
Results
109 patients in the ITT218 received InO (median age, 47 [range, 18–78] years; patients ≥55 years, 43 [39%]). Remission rates and DoR were similar whereas MRD-negativity rates in responders were numerically higher in older patients (Table). In the safety population, grade ≥3 adverse events (AEs) were most frequently cytopenias (neutropenia, 46%; thrombocytopenia, 37%; febrile neutropenia, 24%); these grade ≥3 AEs were more common in patients ≥55 (n=53) vs <55 years (n=86): thrombocytopenia (49% vs 29%), neutropenia (53% vs 42%), febrile neutropenia (28% vs 21%). Patients ≥55 vs <55 years had similar discontinuation rates due to AEs (both 17%). For patients ≥55 vs <55 years, any grade hepatobiliary AE rates were similar (both 26%) and included, hyperbilirubinemia (both 15%), and veno-occlusive liver disease (VOD) including post-SCT VOD (both 11%; 2 fatal in patients <55 years [1 after second SCT]).
Conclusion
InO was highly effective in older patients with relapsed/refractory ALL for whom treatment options are currently limited; responses and safety profiles were generally similar to younger patients and the overall study population.
Session topic: Acute lymphoblastic leukemia - Clinical 1
Keyword(s): Acute lymphoblastic leukemia, Chemotherapy, Phase III, Relapsed acute lymphoblastic leukemia
Abstract: P167
Type: Poster Presentation
Presentation during EHA21: On Friday, June 10, 2016 from 17:15 - 18:45
Location: Poster area (Hall H)
Background
Inotuzumab Ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, has demonstrated superior response vs standard care for relapsed/refractory acute lymphoblastic leukemia (ALL) in the ongoing phase 3 INO-VATE trial (complete remission [CR]/CR with incomplete hematologic recovery [CRi], 81% [95% CI; 72–88]; minimal residual disease [MRD] negativity in responders, 78% [68–87]; median remission duration [DoR], 4.6 [3.9–5.4] months).
Aims
To assess the efficacy and safety of InO in patients with relapsed/refractory ALL aged ≥55 vs <55 years
Methods
Per protocol, the intent-to-treat analyses of CR/CRi included the first 218 of 326 patients randomized (ITT218). The safety population included 139 patients who received ≥1 InO dose (max 1.8 mg/m2/cycle [0.8 mg/m2 on day 1; 0.5 mg/m2 on days 8 and 15 of a 21–28 day cycle for ≤6 cycles]). MRD negativity was assessed by central flow cytometry (<0.01%). Data as of October 2, 2014 are presented (trial ongoing). Informed consent was obtained from all patients.
Results
109 patients in the ITT218 received InO (median age, 47 [range, 18–78] years; patients ≥55 years, 43 [39%]). Remission rates and DoR were similar whereas MRD-negativity rates in responders were numerically higher in older patients (Table). In the safety population, grade ≥3 adverse events (AEs) were most frequently cytopenias (neutropenia, 46%; thrombocytopenia, 37%; febrile neutropenia, 24%); these grade ≥3 AEs were more common in patients ≥55 (n=53) vs <55 years (n=86): thrombocytopenia (49% vs 29%), neutropenia (53% vs 42%), febrile neutropenia (28% vs 21%). Patients ≥55 vs <55 years had similar discontinuation rates due to AEs (both 17%). For patients ≥55 vs <55 years, any grade hepatobiliary AE rates were similar (both 26%) and included, hyperbilirubinemia (both 15%), and veno-occlusive liver disease (VOD) including post-SCT VOD (both 11%; 2 fatal in patients <55 years [1 after second SCT]).
Conclusion
InO was highly effective in older patients with relapsed/refractory ALL for whom treatment options are currently limited; responses and safety profiles were generally similar to younger patients and the overall study population.
Session topic: Acute lymphoblastic leukemia - Clinical 1
Keyword(s): Acute lymphoblastic leukemia, Chemotherapy, Phase III, Relapsed acute lymphoblastic leukemia
Type: Poster Presentation
Presentation during EHA21: On Friday, June 10, 2016 from 17:15 - 18:45
Location: Poster area (Hall H)
Background
Inotuzumab Ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, has demonstrated superior response vs standard care for relapsed/refractory acute lymphoblastic leukemia (ALL) in the ongoing phase 3 INO-VATE trial (complete remission [CR]/CR with incomplete hematologic recovery [CRi], 81% [95% CI; 72–88]; minimal residual disease [MRD] negativity in responders, 78% [68–87]; median remission duration [DoR], 4.6 [3.9–5.4] months).
Aims
To assess the efficacy and safety of InO in patients with relapsed/refractory ALL aged ≥55 vs <55 years
Methods
Per protocol, the intent-to-treat analyses of CR/CRi included the first 218 of 326 patients randomized (ITT218). The safety population included 139 patients who received ≥1 InO dose (max 1.8 mg/m2/cycle [0.8 mg/m2 on day 1; 0.5 mg/m2 on days 8 and 15 of a 21–28 day cycle for ≤6 cycles]). MRD negativity was assessed by central flow cytometry (<0.01%). Data as of October 2, 2014 are presented (trial ongoing). Informed consent was obtained from all patients.
Results
109 patients in the ITT218 received InO (median age, 47 [range, 18–78] years; patients ≥55 years, 43 [39%]). Remission rates and DoR were similar whereas MRD-negativity rates in responders were numerically higher in older patients (Table). In the safety population, grade ≥3 adverse events (AEs) were most frequently cytopenias (neutropenia, 46%; thrombocytopenia, 37%; febrile neutropenia, 24%); these grade ≥3 AEs were more common in patients ≥55 (n=53) vs <55 years (n=86): thrombocytopenia (49% vs 29%), neutropenia (53% vs 42%), febrile neutropenia (28% vs 21%). Patients ≥55 vs <55 years had similar discontinuation rates due to AEs (both 17%). For patients ≥55 vs <55 years, any grade hepatobiliary AE rates were similar (both 26%) and included, hyperbilirubinemia (both 15%), and veno-occlusive liver disease (VOD) including post-SCT VOD (both 11%; 2 fatal in patients <55 years [1 after second SCT]).
Conclusion
InO was highly effective in older patients with relapsed/refractory ALL for whom treatment options are currently limited; responses and safety profiles were generally similar to younger patients and the overall study population.
Session topic: Acute lymphoblastic leukemia - Clinical 1
Keyword(s): Acute lymphoblastic leukemia, Chemotherapy, Phase III, Relapsed acute lymphoblastic leukemia
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