- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Reduced-Intensity Chemotherapy with Mini-Hyper-CVD Plus Inotuzumab Ozogamicin, with or without Blinatumomab, in Older Adults with Newly Diagnosed Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia: Results from a Phase II Study (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_772;
This novel regimen leads to durable remissions and apparent cure in the majority of pts age 60-69 years of age and in those without poor-risk cytogenetic features. To decrease treatment-related mortality, the protocol has been amended to eliminate chemotherapy for pts ≥70 years of age.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Clinical, Review, Journal: Immunotherapy in Pediatric B-Cell Acute Lymphoblastic Leukemia: Advances and Ongoing Challenges. (Pubmed Central) - Nov 3, 2020
In this article, we discuss the clinical biology and treatment of B-ALL with an emphasis on the role of immunotherapy in overcoming the challenges of conventional cytotoxic therapy. As immunotherapy continues to move into the frontline of pediatric B-ALL therapy, we also discuss strategies to address unique side effects associated with these agents and efforts to overcome mechanisms of resistance to immunotherapy.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Validation of the Combinatorial Effect of Blinatumomab and Nivolumab in Cancer Therapy (virtual poster hall) - Nov 3, 2020 - Abstract #SITC2020SITC_2044;
Finally, we have employed humanized mouse models bearing Raji or Daudi tumor cells to further validate this combination treatment in vivo. Both In-vivo and In-vitro data support that Blinatumomab is dominant in activing T cell and Nivolumab can only exhibit synergistic effect under suboptimal dosage of Blinatumomab.Download figure Open in new tab Download powerpoint Abstract 781 Figure 1 Establishment of In vitro co-culture system for CD3 BiTEestablish in vitro human PBMC based system to validate CD3 BiTE functionDownload figure Open in new tab Download powerpoint Abstract 781 Figure 2 Opdivo and CD3 BiTE CombinationOpdivo could further promote T cell activation under the treatment of CD3 BiTE Conclusions Successfully establish in vitro system to evaluate the function of CD3 BiTE and also take advantage of MLR/tumor co-culture system to demonstrate PD1 antibody could further promote T cell activation under appropriate dosage of CD3 BiTE.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Validation of the Combinatorial Effect of Blinatumomab and Nivolumab in Cancer Therapy (virtual poster hall) - Nov 3, 2020 - Abstract #SITC2020SITC_1947;
Finally, we have employed humanized mouse models bearing Raji or Daudi tumor cells to further validate this combination treatment in vivo. Both In-vivo and In-vitro data support that Blinatumomab is dominant in activing T cell and Nivolumab can only exhibit synergistic effect under suboptimal dosage of Blinatumomab.Download figure Open in new tab Download powerpoint Abstract 781 Figure 1 Establishment of In vitro co-culture system for CD3 BiTEestablish in vitro human PBMC based system to validate CD3 BiTE functionDownload figure Open in new tab Download powerpoint Abstract 781 Figure 2 Opdivo and CD3 BiTE CombinationOpdivo could further promote T cell activation under the treatment of CD3 BiTE Conclusions Successfully establish in vitro system to evaluate the function of CD3 BiTE and also take advantage of MLR/tumor co-culture system to demonstrate PD1 antibody could further promote T cell activation under appropriate dosage of CD3 BiTE.
- |||||||||| cyclophosphamide intravenous / Generic mfg.
[VIRTUAL] Update on chimeric antigen receptor – T cells (CAR-T) CD19 therapy: the Sheba experience () - Oct 31, 2020 - Abstract #EHOC2020EHOC_327;
Lympho-depleting conditioning was inducted by fludarabine 25 mg/m2 for 3 days and cyclophosphamide 900 mg/m2 for 1 day, followed by infusion of 1–1.5 × 106 transduced CAR-T cells per kilogram weight...Ten of 37 (27%) ALL patients received prior therapy directed against CD19, such as blinatumomab and Inotuzumab...The manufactured CAR-T products (n = 9) were also subjected to immunophenotypic analysis in order to elucidate the mechanisms of CAR-T cell trafficking and activity. We observed increased immunosuppressive phenotype as well as induction of T cell senescence/exhaustion in non-responding compare to responding patients.4
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal, Adverse events: Management of adverse effects of new monoclonal antibody treatments in acute lymphoblastic leukemia. (Pubmed Central) - Oct 30, 2020
Although these novel immunotherapies have revolutionized the therapeutic landscape, it is important to understand the crucial aspects of administration, especially toxicity. In this article, we review the unique toxicities and adverse effects of blinatumomab and inotuzumab ozogamicin and provide recommendations for prevention of adverse effects as well as the management options for each medication.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Journal: Antibody therapy for acute lymphoblastic leukemia (Pubmed Central) - Oct 21, 2020
Although both the treatments have higher remission and negativity of minimal residual disease rates compared to those in conventional chemotherapy, it is difficult to maintain remission in the long term. Allogeneic hematopoietic stem cell transplantation should be performed as commonly as possible.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, 6 Mercaptopurine / Teva
[VIRTUAL] Multiple relapsed acute lymphoblastic leukemia with t(9;13) in a child () - Oct 21, 2020 - Abstract #EHOC2020EHOC_279;
Orchiectomy was performed for testicular relapse, and REZ-BFM 2016 protocol and then blinatumomab was given...He received weekly intrathecal chemotherapy and FLAG-IDA (fludarabine, high dose cytarabine, G-CSF, and idarubicin) protocol that continued with weekly oral methotrexate and daily 6-mercaptopurine and received 18 Gy cranial radiotherapy...However, two months later, he readmitted with headache and combined CNS and bone marrow involvement was detected and ETO-FLAG (fludarabine, high dose cytarabine, G-CSF, and etoposide) regimen was given. Treatment of relapsed ALL still is a challenge and experimental trials may be considered for these patients.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Trial primary completion date, Combination therapy: Blinatumomab and Pembrolizumab for Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia With High Marrow Lymphoblasts (clinicaltrials.gov) - Oct 19, 2020
P1/2, N=24, Recruiting,
In acute lymphoblastic leukemia, Blinatumomab therapy may be an effective salvage treatment in patients with extramedullary relapse.Keywords: Relapsed acute lymphoblastic leukemia, blinatumomab, allogenic bone marrow transplantation. Trial primary completion date: Aug 2020 --> Aug 2022
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
[VIRTUAL] Development of an in vitro assay to assess bispecific T cell engager using T cells from CD3e humanized mice () - Oct 14, 2020 - Abstract #SITC2020SITC_1055;
A successful example in the clinical is Blinatumomab, a BiTE antibody against CD3/CD19 approved in 2014 to treat acute lymphoblastic leukemia...Conclusions Our data showed the feasibility of using humanized mice T cells as a replacement for hPBMCs to assess BiTE antibody in vitro. We are further validating the application of murine hCD3 T cells for in vivo models to test bispecific T cell engagers.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
[VIRTUAL] Development of an in vitro assay to assess bispecific T cell engager using T cells from CD3e humanized mice () - Oct 14, 2020 - Abstract #SITC2020SITC_320;
A successful example in the clinical is Blinatumomab, a BiTE antibody against CD3/CD19 approved in 2014 to treat acute lymphoblastic leukemia...Conclusions Our data showed the feasibility of using humanized mice T cells as a replacement for hPBMCs to assess BiTE antibody in vitro. We are further validating the application of murine hCD3 T cells for in vivo models to test bispecific T cell engagers.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
[VIRTUAL] Successful administration of blinatumomab in the outpatient pediatric oncology setting () - Oct 8, 2020 - Abstract #ASHP2020ASHP_306;
Based on these findings, better treatment modalities can be offered to pediatric patients and their families for complex, multi-day chemotherapy regimens to prevent prolonged length of stay in the hospital. Multidisciplinary collaboration in conjunction with patient/family understanding and cooperation is necessary for the successful management of outpatient treatments.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Trial completion date, Trial primary completion date: NCI-2017-00596: Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Oct 8, 2020
P2, N=60, Recruiting,
Multidisciplinary collaboration in conjunction with patient/family understanding and cooperation is necessary for the successful management of outpatient treatments. Trial primary completion date: Nov 2020 --> Nov 2021 | Trial completion date: Nov 2020 --> Nov 2021
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, zeluvalimab (AMG 404) / Amgen
Enrollment open, Trial completion date, Trial primary completion date, Combination therapy: Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL (clinicaltrials.gov) - Oct 7, 2020
P1b, N=21, Recruiting,
Trial primary completion date: Nov 2020 --> Nov 2021 | Trial completion date: Nov 2020 --> Nov 2021 Not yet recruiting --> Recruiting | Trial completion date: Apr 2023 --> Jul 2022 | Trial primary completion date: Apr 2023 --> Jul 2022
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Utility Weight Considerations in Nice Immune Checkpoint Inhibitor Oncology Appraisals () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_870;
CONCLUSIONS : This review provides insights into the most accepted approaches to derive and apply utility weights in immune checkpoint inhibitor oncology economic models developed for NICE appraisals. These results may be used to inform the utility weight methodology for use in future NICE submissions and will improve consistency of checkpoint inhibitor oncology appraisals going forward.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Review, Journal: Concepts in immuno-oncology: tackling B cell malignancies with CD19-directed bispecific T cell engager therapies. (Pubmed Central) - Oct 2, 2020
Patients receiving blinatumomab may experience cytokine release syndrome and neurotoxicity; however, these events may be less frequent and severe than in patients receiving other CD19-targeted immunotherapies, such as chimeric antigen receptor T cell therapy. We review BiTE technology for treating malignancies that express CD19, analyzing the benefits and limitations of this bispecific T cell engager platform from clinical experience with blinatumomab.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia (clinicaltrials.gov) - Sep 30, 2020
P2, N=20, Recruiting,
We review BiTE technology for treating malignancies that express CD19, analyzing the benefits and limitations of this bispecific T cell engager platform from clinical experience with blinatumomab. Trial completion date: Jan 2021 --> Jan 2022 | Trial primary completion date: Aug 2020 --> Aug 2021
- |||||||||| Thymoglobulin (anti-thymocyte globulin (rabbit)) / Sanofi, Blincyto (blinatumomab) / Astellas, Amgen
Trial primary completion date: Provision of TCR?? T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Na (clinicaltrials.gov) - Sep 24, 2020
P2, N=52, Recruiting,
Trial completion date: Jan 2021 --> Jan 2022 | Trial primary completion date: Aug 2020 --> Aug 2021 Trial primary completion date: Aug 2020 --> Nov 2020
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
[VIRTUAL] Ph-positive and ph-like all: how can we further improve? (ATİLLA YALÇIN HALL) - Sep 23, 2020 - Abstract #EHOC2020EHOC_81;
The GIMEMA LAL 2317 has used blinatumomab in the front-line Ph- ALL protocol (recently closed) and Ph-like cases are being identified using a predictor described by our group (Chiaretti et al, BJH, 2018). In adult B-lineage ALL, Ph+ and Ph-like ALL account for 35–60% of cases, depending on age, making them the most prevalent genetic ALL subgroup.
- |||||||||| Leustatin (cladribine) / J&J, Opdivo (nivolumab) / Ono Pharma, BMS, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] New drugs for low grade lymphoproliferative diseases (ATİLLA YALÇIN HALL) - Sep 23, 2020 - Abstract #EHOC2020EHOC_28;
Tazemetostat a novel EZH2 inhibitor recently received accelerated approval by FDA for patients with RR-FL and EZH2 gene mutations, following the results of a phase-II study...Immune check point inhibitors (Nivolumab, Pemprolizumab, Atezolizumab) are promising as third line treatment and beyond. Other agents under investigation include the inhibitor of nuclear export selinexor, the SYK inhibitor entospletinib, the dual SYK/JAK inhibitor certulatinib and the CDK inhibitors flavopiridol and dinaciclib.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
New P2 trial: Blinatumomab Bridging Therapy (clinicaltrials.gov) - Sep 19, 2020
P2, N=35, Not yet recruiting,
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
[VIRTUAL] Not All Colonic Masses Are Adenocarcinoma () - Sep 15, 2020 - Abstract #ACG2020ACG_1195;
Rituximab was added due to CD20+ status...After receiving 2 cycles of blinatumomab, a bone marrow biopsy supported clinical remission...Support for early endoscopy in patients undergoing immunotherapy and presenting with GI complaints may help to exclude GI involvement prior to declaring remission. A future prospective trial to identify risk factors for patients with ALL at high risk for GI infiltration would be valuable to determine those more likely to benefit from early endoscopic evaluation, and thus avoid unnecessary procedures in a population already at elevated procedural risk due to immunocompromised state and common presence of cytopenias.
|
