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Association details:
| Biomarker: | BCR-ABL1 fusion |
|---|---|
| Cancer: | Acute Lymphocytic Leukemia |
| Drug: | Iclusig (ponatinib) (Multi-tyrosine kinase inhibitor) + Blincyto (blinatumomab) (CD3 agonist, CD19 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
2827 Chemotherapy-Free Combination of Blinatumomab and Ponatinib in Adults with Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia: Updates from a Phase II TrialClinically Relevant Abstract
Published date:
11/02/2023
Excerpt:
The chemotherapy-free combination of blinatumomab and ponatinib is safe and effective in newly diagnosed Ph-positive ALL, with high rates of MRD negativity. Encouraging duration of remission and OS has been observed without the need for HSCT.
Source:
Title:
Subgroup analysis from a phase II trial of ponatinib and blinatumomab in relapsed/refractory (R/R) Philadelphia chromosome-positive acute lymphoblastic leukemia or chronic myeloid leukemia in lymphoid blast phase.
Published date:
05/25/2023
Excerpt:
In this phase II trial, pts with R/R Ph+ ALL or CML-LBP received up to 5 cycles of blinatumomab. Pts received ponatinib 30mg daily....Among the 14 pts with R/R Ph+ ALL, the rate of CR/CRi was 92% (12 of 13 evaluable pts), with CR in 11 (85%) pts. MMR was achieved in 86% and CMR in 79%....The estimated 2-year EFS and OS for the R/R cohort were 50% and 64%, respectively….The combination of ponatinib and blinatumomab is an effective and well-tolerated chemotherapy-free regimen for pts with R/R Ph+ ALL.
DOI:
10.1200/JCO.2023.41.16_suppl.e19038
Trial ID:
Source:
Title:
A phase II trial of ponatinib and blinatumomab in adults with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL).
Published date:
05/25/2023
Excerpt:
In this phase II study, patients (pts) with newly diagnosed Ph+ ALL received up to 5 cycles of blinatumomab in combination with ponatinib, followed by ponatinib maintenance for at least 5 years….Among 35 pts evaluable for hematologic response, 23 (97%) achieved CR/CRi; 1 pt had early death. Among 48 pts evaluable for molecular response, 34 (71%) achieved CMR after 1 cycle, and 43 (90%) achieved CMR at any time....There have been no leukemia-related deaths, the estimated 2-year EFS and OS are both 90%....The chemotherapy-free combination of ponatinib and blinatumomab is safe and effective in newly diagnosed Ph+ ALL...
DOI:
10.1200/JCO.2023.41.16_suppl.e19013
Trial ID:
Source:
Title:
Low-intensity chemotherapy (mini-HCVD) and ponatinib followed by blinatumomab (blina) and ponatinib for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL): A phase II study.
Published date:
05/25/2023
Excerpt:
Pts with newly diagnosed (ND) or relapsed/refractory (R/R) Ph+ ALL... were eligible. Mini-HCVD alternating with methotrexate (MTX)/cytarabine were given on Cycles(C) 1-4, followed by blina/ponatinib....All evaluable pts achieved CR….With a median follow-up of 28 months (range, 6-37), the 2-year continuous remission duration and OS rates were 93% and 82% in the entire cohort, and 90% and 82% in the ND cohort, respectively….In Ph+ ALL, the sequential combination of mini-HCVD/ponatinib followed by blina/ponatinib resulted in high rates of CMR, encouraging survival, and had an acceptable safety profile.
Secondary therapy:
Mini-HCVD
DOI:
10.1200/JCO.2023.41.16_suppl.e19028
Trial ID:
Source:
Title:
Ponatinib and blinatumomab for Philadelphia chromosome-positive acute lymphoblastic leukaemia: a US, single-centre, single-arm, phase 2 trial
Published date:
11/16/2022
Excerpt:
The chemotherapy-free combination of ponatinib and blinatumomab resulted in high rates of complete molecular response in patients with newly diagnosed and relapsed or refractory Ph-positive acute lymphoblastic leukaemia.
DOI:
10.1016/S2352-3026(22)00319-2
Trial ID:
Source:
Title:
A Phase II Study of the Sequential Combination of Low-Intensity Chemotherapy (mini-hyper-CVD) and Ponatinib Followed By Blinatumomab and Ponatinib in Patients with Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)Clinically Relevant Abstract
Published date:
11/15/2022
Excerpt:
With a median follow-up of 23 months (range, 6-31), the 2-year CRD and OS rates are 90% and 78%, respectively, across all cohorts (Figure 1), and are 89% and 82%, respectively in the ND cohort...Sequential combination of low-intensity chemotherapy and ponatinib followed by blinatumomab and ponatinib is highly effective and well tolerated in Ph+ ALL.
Secondary therapy:
Chemotherapy
DOI:
https://doi.org/10.1182/blood-2022-167883
Test:
Source:
Title:
4046 Ponatinib and Blinatumomab for Patients with Relapsed/Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia or Chronic Myeloid Leukemia in Lymphoid Blast Phase: A Subgroup Analysis from a Phase II StudyClinically Relevant Abstract
Published date:
11/03/2022
Excerpt:
Among the 14 pts with R/R Ph+ ALL, 1 was in CR but still with detectable BCR::ABL1 at enrollment. 12 of the 13 evaluable pts (92%) achieved CR/CRi, with CR in 11 pts (85%). The one non-responding pt had received prior ponatinib-based therapy in an earlier salvage regimen. After one cycle, 11/14 (79%) achieved MMR and 10/14 pts (71%) achieved CMR. 12/14 (86%) achieved MMR and 11/14 pts (79%) achieved CMR at any time over the course of therapy.The chemotherapy-free combination of ponatinib and blinatumomab is a safe and effective regimen in both R/R Ph+ ALL and CML-LBP. High rates of deep molecular response were observed in R/R Ph+ ALL.
DOI:
https://doi.org/10.1182/blood-2022-157323
Source:
Title:
213 Ponatinib and Blinatumomab for Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Subgroup Analysis from a Phase II StudyClinically Relevant Abstract
Published date:
11/03/2022
Excerpt:
In this phase II study, pts ≥18 years of age with newly diagnosed Ph+ ALL were eligible….Simultaneous ponatinib and blinatumomab is safe and effective in pts with newly diagnosed Ph+ ALL.
DOI:
https://doi.org/10.1182/blood-2022-157775
Source:
Title:
Combination of ponatinib and blinatumomab in Philadelphia chromosome-positive acute lymphoblastic leukemia: Early results from a phase II study.
Published date:
05/28/2021
Excerpt:
Overall, 95% of patients responded; the response rate was 100% in the ND cohort and 88% in the R/R cohort....combination of ponatinib and blinatumomab shows encouraging results in Ph+ ALL.
DOI:
10.1200/JCO.2021.39.15_suppl.7001
Trial ID:
Source:
Title:
INTERIM RESULTS OF A PHASE II STUDY OF BLINATUMOMAB PLUS PONATINIB FOR PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
Published date:
05/12/2021
Excerpt:
The chemotherapy-free combination of ponatinib and blinatumomab shows encouraging safety and efficacy in Ph+ ALL, with high rates of CMR and durable remissions...
