BLINATUMOMAB SAFETY AND ACTIVITY IN OLDER PATIENTS WITH RELAPSED/REFRACTORY B?PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA IN TWO PHASE 2 STUDIES
(Abstract release date: 05/21/15)
EHA Library. Kantarjian H. 06/12/15; 103113; S115
H Kantarjian
Contributions
Contributions
Abstract
Abstract: S115
Type: Oral Presentation
Presentation during EHA20: From 12.06.2015 12:30 to 12.06.2015 12:45
Location: Room C1
Background
Treatment options for older patients with relapsed/refractory acute lymphoblastic leukemia (ALL) are limited. Blinatumomab is a bispecific T-cell engager (BiTE®) antibody construct that directs cytotoxic T cells to CD19-expressing B cells, and is approved in the US for treatment of Ph-negative relapsed/refractory ALL. In two phase 2 adult studies of blinatumomab (Topp MS, et al. J Clin Oncol. 2014;32:4134-40; Topp MS, et al. Lancet Oncol. 2015;16:57-66), 69% and 43% of patients, respectively, achieved complete response (CR) or CR with partial hematologic recovery (CRh*).
Aims
We report pooled data for the combined subsets of older patients (≥ 65 years).
Methods
Patients with relapsed/refractory, Ph-negative B-precursor ALL received open-label blinatumomab by continuous intravenous infusion (4 weeks on/2 weeks off). Patients achieving CR or CRh* after two cycles could receive three consolidation cycles. Response was assessed by bone marrow aspiration and complete blood count with differential. CR required blasts < 5%, ANC > 1000/μL and platelets > 100,000/μL. CRh* required blasts < 5%, ANC > 500/μL and platelets > 50,000/μL. Minimal residual disease (MRD) was detected by ASO-PCR of Ig heavy chain loci.
Results
A total of 36 older patients (median age 70 years, range 65-79) received blinatumomab for a median (range) of 2 (1-6) cycles. Twenty (56%) patients achieved best response of CR/CRh* within two cycles, including 14 (39%) CR and 6 (17%) CRh*. Among patients who responded to blinatumomab, 16 (80%) had an MRD response; of these, 12 (60%) had complete MRD response (undetectable MRD) and 4 (20%) others had detectable MRD but with < 10-4 blasts. With median follow-up of 18.2 months, median (range) relapse-free survival was 7.4 (1.0-34.0) months. With median follow-up of 29.4 months, overall survival among patients was 5.5 (0.3-41.9) months. Ten (28%) patients were alive at last follow up, including 6 in sustained remission. Two (10%) of the patients who responded to blinatumomab underwent allogeneic hematopoietic stem cell transplantation (HSCT) after blinatumomab therapy. Treatment-emergent adverse events (AE) CTCAE grade ≥ 3 were reported for 31 (86%) patients, most commonly febrile neutropenia (22%) and neutropenia (19%). Neurologic AE occurred in 26 (72%) patients, including grade ≥ 3 events for 28%. One (3%) patient had grade ≥ 3 cytokine release syndrome. Of 7 fatal AEs reported in patients, none were considered related to treatment.
Summary
Older patients (≥ 65 years) with relapsed/refractory ALL in two phase 2 studies of single-agent blinatumomab had similar treatment responses and tolerability compared with patients in the overall study populations.
Keyword(s): Antibody, CD19, Immunotherapy
Session topic: ALL clinical trials
Type: Oral Presentation
Presentation during EHA20: From 12.06.2015 12:30 to 12.06.2015 12:45
Location: Room C1
Background
Treatment options for older patients with relapsed/refractory acute lymphoblastic leukemia (ALL) are limited. Blinatumomab is a bispecific T-cell engager (BiTE®) antibody construct that directs cytotoxic T cells to CD19-expressing B cells, and is approved in the US for treatment of Ph-negative relapsed/refractory ALL. In two phase 2 adult studies of blinatumomab (Topp MS, et al. J Clin Oncol. 2014;32:4134-40; Topp MS, et al. Lancet Oncol. 2015;16:57-66), 69% and 43% of patients, respectively, achieved complete response (CR) or CR with partial hematologic recovery (CRh*).
Aims
We report pooled data for the combined subsets of older patients (≥ 65 years).
Methods
Patients with relapsed/refractory, Ph-negative B-precursor ALL received open-label blinatumomab by continuous intravenous infusion (4 weeks on/2 weeks off). Patients achieving CR or CRh* after two cycles could receive three consolidation cycles. Response was assessed by bone marrow aspiration and complete blood count with differential. CR required blasts < 5%, ANC > 1000/μL and platelets > 100,000/μL. CRh* required blasts < 5%, ANC > 500/μL and platelets > 50,000/μL. Minimal residual disease (MRD) was detected by ASO-PCR of Ig heavy chain loci.
Results
A total of 36 older patients (median age 70 years, range 65-79) received blinatumomab for a median (range) of 2 (1-6) cycles. Twenty (56%) patients achieved best response of CR/CRh* within two cycles, including 14 (39%) CR and 6 (17%) CRh*. Among patients who responded to blinatumomab, 16 (80%) had an MRD response; of these, 12 (60%) had complete MRD response (undetectable MRD) and 4 (20%) others had detectable MRD but with < 10-4 blasts. With median follow-up of 18.2 months, median (range) relapse-free survival was 7.4 (1.0-34.0) months. With median follow-up of 29.4 months, overall survival among patients was 5.5 (0.3-41.9) months. Ten (28%) patients were alive at last follow up, including 6 in sustained remission. Two (10%) of the patients who responded to blinatumomab underwent allogeneic hematopoietic stem cell transplantation (HSCT) after blinatumomab therapy. Treatment-emergent adverse events (AE) CTCAE grade ≥ 3 were reported for 31 (86%) patients, most commonly febrile neutropenia (22%) and neutropenia (19%). Neurologic AE occurred in 26 (72%) patients, including grade ≥ 3 events for 28%. One (3%) patient had grade ≥ 3 cytokine release syndrome. Of 7 fatal AEs reported in patients, none were considered related to treatment.
Summary
Older patients (≥ 65 years) with relapsed/refractory ALL in two phase 2 studies of single-agent blinatumomab had similar treatment responses and tolerability compared with patients in the overall study populations.
Keyword(s): Antibody, CD19, Immunotherapy
Session topic: ALL clinical trials
Abstract: S115
Type: Oral Presentation
Presentation during EHA20: From 12.06.2015 12:30 to 12.06.2015 12:45
Location: Room C1
Background
Treatment options for older patients with relapsed/refractory acute lymphoblastic leukemia (ALL) are limited. Blinatumomab is a bispecific T-cell engager (BiTE®) antibody construct that directs cytotoxic T cells to CD19-expressing B cells, and is approved in the US for treatment of Ph-negative relapsed/refractory ALL. In two phase 2 adult studies of blinatumomab (Topp MS, et al. J Clin Oncol. 2014;32:4134-40; Topp MS, et al. Lancet Oncol. 2015;16:57-66), 69% and 43% of patients, respectively, achieved complete response (CR) or CR with partial hematologic recovery (CRh*).
Aims
We report pooled data for the combined subsets of older patients (≥ 65 years).
Methods
Patients with relapsed/refractory, Ph-negative B-precursor ALL received open-label blinatumomab by continuous intravenous infusion (4 weeks on/2 weeks off). Patients achieving CR or CRh* after two cycles could receive three consolidation cycles. Response was assessed by bone marrow aspiration and complete blood count with differential. CR required blasts < 5%, ANC > 1000/μL and platelets > 100,000/μL. CRh* required blasts < 5%, ANC > 500/μL and platelets > 50,000/μL. Minimal residual disease (MRD) was detected by ASO-PCR of Ig heavy chain loci.
Results
A total of 36 older patients (median age 70 years, range 65-79) received blinatumomab for a median (range) of 2 (1-6) cycles. Twenty (56%) patients achieved best response of CR/CRh* within two cycles, including 14 (39%) CR and 6 (17%) CRh*. Among patients who responded to blinatumomab, 16 (80%) had an MRD response; of these, 12 (60%) had complete MRD response (undetectable MRD) and 4 (20%) others had detectable MRD but with < 10-4 blasts. With median follow-up of 18.2 months, median (range) relapse-free survival was 7.4 (1.0-34.0) months. With median follow-up of 29.4 months, overall survival among patients was 5.5 (0.3-41.9) months. Ten (28%) patients were alive at last follow up, including 6 in sustained remission. Two (10%) of the patients who responded to blinatumomab underwent allogeneic hematopoietic stem cell transplantation (HSCT) after blinatumomab therapy. Treatment-emergent adverse events (AE) CTCAE grade ≥ 3 were reported for 31 (86%) patients, most commonly febrile neutropenia (22%) and neutropenia (19%). Neurologic AE occurred in 26 (72%) patients, including grade ≥ 3 events for 28%. One (3%) patient had grade ≥ 3 cytokine release syndrome. Of 7 fatal AEs reported in patients, none were considered related to treatment.
Summary
Older patients (≥ 65 years) with relapsed/refractory ALL in two phase 2 studies of single-agent blinatumomab had similar treatment responses and tolerability compared with patients in the overall study populations.
Keyword(s): Antibody, CD19, Immunotherapy
Session topic: ALL clinical trials
Type: Oral Presentation
Presentation during EHA20: From 12.06.2015 12:30 to 12.06.2015 12:45
Location: Room C1
Background
Treatment options for older patients with relapsed/refractory acute lymphoblastic leukemia (ALL) are limited. Blinatumomab is a bispecific T-cell engager (BiTE®) antibody construct that directs cytotoxic T cells to CD19-expressing B cells, and is approved in the US for treatment of Ph-negative relapsed/refractory ALL. In two phase 2 adult studies of blinatumomab (Topp MS, et al. J Clin Oncol. 2014;32:4134-40; Topp MS, et al. Lancet Oncol. 2015;16:57-66), 69% and 43% of patients, respectively, achieved complete response (CR) or CR with partial hematologic recovery (CRh*).
Aims
We report pooled data for the combined subsets of older patients (≥ 65 years).
Methods
Patients with relapsed/refractory, Ph-negative B-precursor ALL received open-label blinatumomab by continuous intravenous infusion (4 weeks on/2 weeks off). Patients achieving CR or CRh* after two cycles could receive three consolidation cycles. Response was assessed by bone marrow aspiration and complete blood count with differential. CR required blasts < 5%, ANC > 1000/μL and platelets > 100,000/μL. CRh* required blasts < 5%, ANC > 500/μL and platelets > 50,000/μL. Minimal residual disease (MRD) was detected by ASO-PCR of Ig heavy chain loci.
Results
A total of 36 older patients (median age 70 years, range 65-79) received blinatumomab for a median (range) of 2 (1-6) cycles. Twenty (56%) patients achieved best response of CR/CRh* within two cycles, including 14 (39%) CR and 6 (17%) CRh*. Among patients who responded to blinatumomab, 16 (80%) had an MRD response; of these, 12 (60%) had complete MRD response (undetectable MRD) and 4 (20%) others had detectable MRD but with < 10-4 blasts. With median follow-up of 18.2 months, median (range) relapse-free survival was 7.4 (1.0-34.0) months. With median follow-up of 29.4 months, overall survival among patients was 5.5 (0.3-41.9) months. Ten (28%) patients were alive at last follow up, including 6 in sustained remission. Two (10%) of the patients who responded to blinatumomab underwent allogeneic hematopoietic stem cell transplantation (HSCT) after blinatumomab therapy. Treatment-emergent adverse events (AE) CTCAE grade ≥ 3 were reported for 31 (86%) patients, most commonly febrile neutropenia (22%) and neutropenia (19%). Neurologic AE occurred in 26 (72%) patients, including grade ≥ 3 events for 28%. One (3%) patient had grade ≥ 3 cytokine release syndrome. Of 7 fatal AEs reported in patients, none were considered related to treatment.
Summary
Older patients (≥ 65 years) with relapsed/refractory ALL in two phase 2 studies of single-agent blinatumomab had similar treatment responses and tolerability compared with patients in the overall study populations.
Keyword(s): Antibody, CD19, Immunotherapy
Session topic: ALL clinical trials
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