- |||||||||| Venclexta (venetoclax) / Roche, AbbVie
A PHASE II STUDY OF MINI-HYPER-CVD PLUS VENETOCLAX IN PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE ACUTE LYMPHOBLASTIC LEUKEMIA () - May 13, 2022 - Abstract #EHA2022EHA_648; Responding pts received vincristine and prednisone maintenance with VEN daily on D1-14 of each 28-day cycle for up to 2 yrs...Of the 15 B-ALL pts, 6 had previously received both blinatumomab (blina) and inotuzumab (INO), 7 had received blina without INO, and 2 had received neither...Fig.1: (A) Patient disposition and survival, (B) OS and RFS for the entire cohort, (C) OS of responders and non-responders Conclusion Low dose combination chemotherapy with VEN in a population of heavily pretreated R/R ALL was well-tolerated and resulted in a response rate of 63%. This study has now been amended to add navitoclax in an attempt to further improve outcomes.
- |||||||||| Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
A PHASE II STUDY OF INOTUZUMAB OZOGAMICIN FOR THE TREATMENT OF MEASURABLE RESIDUAL DISEASE-POSITIVE B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA () - May 13, 2022 - Abstract #EHA2022EHA_647; INO was given at a dose of 0.6 mg/m 2 on D1 and 0.3 mg/m 2 on D8 of C1 and 0.3 mg/m 2 on D1 and 8 of subsequent cycles (up to 6 total cycles, given every 21-28 days) along with ursodiol prophylaxis...Twelve pts (60%) had Ph+ B-ALL, 11 of whom received concurrent ponatinib and 1 dasatinib...Eleven pts (55%) had received prior blinatumomab (blina) and 4 pts (20%) had prior stem cell transplantation (SCT)...Ten pts (50%) had grade 3-4 hematological toxicities (primarily neutropenia). Conclusion Low-dose, fractionated INO is a well-tolerated option for MRD eradication in Ph+ and Ph- B-ALL pts, including in those with prior blina exposure.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
LONG TERM OUTCOMES OF NEWLY DIAGNOSED CRLF2 REARRANGED B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA () - May 13, 2022 - Abstract #EHA2022EHA_646; Table 1: Disease and treatment parameters Conclusion Despite improvements in treatment options, CRLF2 overexpressed B-ALL continue to have inferior outcomes. Earlier initiation of targeted therapies might improve outcomes.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
HYPER-CVAD WITH SEQUENTIAL BLINATUMOMAB, WITH OR WITHOUT INOTUZUMAB OZOGAMICIN, IN ADULTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-NEGATIVE B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA () - May 13, 2022 - Abstract #EHA2022EHA_635; Pts with CD20+ disease (≥1% cells) received 8 doses of ofatumumab (2000 mg) or rituximab (375 mg/m 2 )...Conclusion Hyper-CVAD with sequential blinatumomab, with or without INO, is highly effective as frontline treatment of Ph-negative B-cell ALL, with an overall MRD negativity rate of 95% and a 3-year OS rate of 85%. Early outcomes with the addition of INO to this regimen are encouraging, with no relapses or deaths observed to date.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
BLINATUMOMAB ADDED TO PREPHASE AND CONSOLIDATION THERAPY IN NEWLY DIAGNOSED PRECURSOR B-ALL IN ADULTS. A PHASE II HOVON TRIAL () - May 13, 2022 - Abstract #EHA2022EHA_633; P2 Treatment was based on a pediatric inspired protocol ( HOVON 70, Rijneveld et al., 2011) with reduced doses of anthracyclines, MTX, etoposide and PEG-ASP for pts ≥40y old...Rituximab (if CD20+), prophylactic ITs and imatinib (if Ph+) were standard...TABLE Pt characteristics Conclusion Blina can safely be added to prephase of an intensified pediatric schedule for newly diagnosed ALL up to 70y of age, albeit with dose reductions for PEG-ASP, doxorubicin and dexamethasone...The early addition of blina resulted in very early achievement of MRD negativity with 53% after prephase and 91% after blina cons-1. Further reductions of chemotherapy should be explored (especially for Ph+) if these results are maintained with longer follow-up.
- |||||||||| Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
FORTY MONTHS UPDATE OF THE GIMEMA LAL2116 (D-ALBA) PROTOCOL AND ANCILLARY LAL2217 STUDY FOR NEWLY DIAGNOSED ADULT PH+ ALL () - May 13, 2022 - Abstract #EHA2022EHA_624; Among the few relapsed cases, we observed a rather high incidence of CNS involvements. These results represent the scientific rationale for the ongoing phase 3 GIMEMA LAL2820 trial, where dasatinib has been substituted by ponatinib, CNS prophylaxis has been increased, and transplant allocation is based on genomic features and minimal residual disease monitoring.
- |||||||||| azacitidine / Generic mfg.
AZACITIDINE AS TREATMENT OF KMT2A INFANT ACUTE LYMPHOBLASTIC LEUKEMIA: SINGLE CENTER EXPERIENCE () - May 13, 2022 - Abstract #EHA2022EHA_610; AZA was administered every 21 days (d) for 4 cycles (cy), with the following schedule: 55 mg/m 2 for 5 d, 55 mg/m 2 for 7 d, 75 mg/m 2 for 5 d, 75 mg/m 2 for 7 d, respectively; prednisone 1 mg/m 2 was associated to each cycle...The child received consolidation chemotherapy followed by 2 cy of bispecific CD3-CD19 antibody (ab) Blinatumomab and underwent allogeneic hematopoietic stem cell transplant (HSCT) from matched unrelated donor (MUD) with detectable MRD...Due to early relapse after HSCT, he received 2 cy of anti-CD22 ab Inotuzumab, achieving CR without platelet recovery (CRi)...Preclinical studies have revealed heterogeneous results when HMA are combined with cytotoxic drugs; results of two pilot trials of AZA combined with chemotherapy are still ongoing. Further clinical trials could clarify the optimal schedule, timings and dosage of HMA.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Journal: Innovative Approaches to the Management of Acute Lymphoblastic Leukemia Across the Age Spectrum. (Pubmed Central) - May 10, 2022 Although allogeneic hematopoietic stem cell transplant was previously routinely used as consolidation for adults with ALL, incorporation of measurable residual disease and other risk stratification strategies has enabled better identification of patients who will benefit from allogeneic hematopoietic stem cell transplant. Ongoing clinical trials investigating these approaches will continue the evolution of treatment approaches for adults with ALL, with further improvement in outcomes anticipated.
- |||||||||| S63845 / Servier, Novartis, Ligand, Blincyto (blinatumomab) / Astellas, Amgen, Koselugo (selumetinib) / Merck (MSD), AstraZeneca
Use of luciferase-labeled target cells to explore immune cell killing in high throughput format () - May 9, 2022 - Abstract #CIMT2022CIMT_233; Depending on compound combination, we observe synergistic but also antagonistic effects. Our data support the outstanding usefulness of this methodological approach for the exploration of bispecific cytotoxic immune cell engager agents.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Blinatumomab Nonresponse and High-Disease Burden Are Associated With Inferior Outcomes After CD19-CAR for B-ALL. (Pubmed Central) - May 6, 2022 No abstract available With the largest series to date in pediatric CD19-CAR, and, to our knowledge, the first to study the impact of sequential CD19 targeting, we demonstrate that blinatumomab nonresponse and high-disease burden were independently associated with worse RFS and EFS, identifying important indicators of long-term outcomes following CD19-CAR.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal, Oncolytic virus, IO biomarker: CD19-targeted BiTE expression by an oncolytic vaccinia virus significantly augments therapeutic efficacy against B-cell lymphoma. (Pubmed Central) - May 6, 2022 More importantly, treatment with OVV-CD19BiTE both in vitro and in vivo resulted in potent antitumor activity in comparison with control OVV or blinatumomab, a first-in-class BiTE, thereby resulting in long-term tumor remissions without relapse. The study provides strong evidence for the therapeutic benefits of CD19-targeting BiTE expression by OVV, and suggests the feasibility of testing the approach in clinical trials.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Keytruda (pembrolizumab) / Merck (MSD)
Enrollment change, Trial completion date, Trial termination, 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) - May 3, 2022 P1/2, N=14, Terminated, No abstract available N=24 --> 14 | Trial completion date: Aug 2023 --> Apr 2022 | Recruiting --> Terminated | Trial primary completion date: Aug 2022 --> Apr 2022
- |||||||||| Review, Journal: Bispecific Antibodies for Non-Hodgkin Lymphoma Treatment. (Pubmed Central) - Apr 30, 2022
However, several CD20 × CD3 BsAbs including odronextamab, mosunetuzumab, glofitamab, and epcoritamab emerged recently...In addition, how do BsAbs compare to CAR T-cell therapy and how to choose and sequence between BsAbs and CAR T-cell therapy need to be addressed. While many of these critical questions remain to be answered in clinical studies, we believe the future of BsAbs in the NHL is very bright.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Inpatient outcomes of blinatumomab use: A national inpatient sample analysis. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_4368; While many of these critical questions remain to be answered in clinical studies, we believe the future of BsAbs in the NHL is very bright. In this cross-sectional study of a large national cohort of patients receiving inpatient blinatumomab, multiple blinatumomab associated toxicities led to increased LOS and cost of hospitalization.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal, IO biomarker: Optimization of therapeutic T cell expansion in G-Rex device and applicability to large-scale production for clinical use. (Pubmed Central) - Apr 26, 2022 Given the need to increase the efficiency and safety of large-scale T cell expansion for clinical use, we have optimized the method to expand in G-Rex devices both cytokine-induced killer cells (CIKs) from peripheral or cord blood and blinatumomab-expanded T cells (BETs)...CIK-Gs also showed therapeutic activity in vivo in the Ph pre-B ALL-2 model in mice. The expansion of both CIKs and BETs in G-Rex was validated in good manufacturing practices (GMP) conditions, and we plan to use G-Rex for T cell expansion in future clinical studies.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Oncaspar liquid (pegaspargase) / Servier, Unituxin (dinutuximab) / United Therapeutics Corp
Clinical, Review, Journal: Clinical pharmacology of cytotoxic drugs in neonates and infants: Providing evidence-based dosing guidance. (Pubmed Central) - Apr 22, 2022 For the remaining drugs, including commonly used agents such as cisplatin, cytarabine, ifosfamide, and methotrexate, pharmacological evidence for dosing in infants was limited or non-existent: grades C and D were scored for 10 and 2 drugs, respectively. The review provides clinically relevant evidence-based dosing guidance for cytotoxic drugs in neonates and infants.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Review, Journal, IO biomarker: Targeted inhibitors and antibody immunotherapies: Novel therapies for paediatric leukaemia and lymphoma. (Pubmed Central) - Apr 22, 2022 Considering the number of oncology medicinal products available for adults and the rarity of paediatric cancers, prioritisation based on scientific evidence and medical need, as well as international collaboration, is critical. Herein, we review the current status of drug development for children with leukaemia and lymphoma, excluding cellular therapy despite its well-known significance.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Qarziba (dinutuximab beta) / Jazz, Blincyto (blinatumomab) / Astellas, Amgen
Journal: Market access to new anticancer medicines for children and adolescents with cancer in Europe. (Pubmed Central) - Apr 22, 2022 This study reveals ample variability in HTA decision making in nine European Union countries. Collaboration and alignment of required evidence is needed to facilitate robust scientific HTA assessments, also considering methodological challenges in paediatric oncology.
- |||||||||| Jakafi (ruxolitinib) / Novartis, Incyte, Iclusig (ponatinib) / Takeda, Otsuka, Incyte, Blincyto (blinatumomab) / Astellas, Amgen
OUTCOMES IN A PREDOMINANTLY HISPANIC/LATINO PATIENT COHORT WITH PHILADELPHIA-LIKE B-ALL () - Apr 20, 2022 - Abstract #ASPHO2022ASPHO_314; Despite most of the patients receiving targeted agents with upfront therapy, they frequently experienced disease relapse. Further analysis of recent clinical trials incorporating therapy targeting JAK-STAT pathways and ABL class fusions will characterize the utility of these treatment options for patients with Ph-like B-ALL.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
A BALANCING ACT: BLINATUMOMAB USE IN A RARE OCCURRENCE OF PH+ ALL IN A PATIENT WITH DOWN SYNDROME () - Apr 20, 2022 - Abstract #ASPHO2022ASPHO_14; We were able to successfully achieve remission in our patient with DS and Ph+ B-ALL while avoiding further toxicities from traditional chemotherapy using three cycles of blinatumomab. Blinatumomab offers a promising addition to standard chemotherapy and imatinib for Ph+ B-ALL in DSpatients.
- |||||||||| Journal, CAR T-Cell Therapy: Management of relapsed or refractory large B-cell lymphoma in patients ineligible for CAR-T cell therapy. (Pubmed Central) - Apr 20, 2022
Navigating this scenario, will uncover new challenges, including identifying an ideal sequence for these therapies, the most effective combinations, and search for consistent predictive factors to help selecting the appropriate population of LBCL patients. At present, supporting clinical research for CAR-T ineligible patients, a new and challenging group, must remain a major focus that is complementary to advances in CAR T-cell therapy.
- |||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Journal: Lineage Conversion in Pediatric B-Cell Precursor Acute Leukemia under Blinatumomab Therapy. (Pubmed Central) - Apr 19, 2022 The immunophenotype of an existing leukemia sometimes changes via different mechanisms and with different additional molecular changes. Careful investigation of all BM compartments together with all molecular -minimal residual disease studies can lead to reliable identification of lineage switch.
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