- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
Clinical, Journal: Moxetumomab Pasudotox: Clinical Experience in Relapsed/Refractory Hairy Cell Leukemia. (Pubmed Central) - Jul 11, 2020
A limited review of the literature on HCL was undertaken. Nursing care of patients prescribed moxetumomab pasudotox includes monitoring clinical and laboratory parameters, managing side effects, being aware of signs of serious side effects, and maintaining patient hydration during administration.
- |||||||||| Journal: Novel therapeutics in hairy cell leukemia. (Pubmed Central) - Jun 15, 2020
Expert opinion: Despite the number of prospective studies recently published on these agents in HCL, questions remain about which agents to use, when to best utilize them, how to best dose or schedule them, and the role of combination therapy. Further clinical research is required to answer these questions and to discover other drugs effective in the treatment of relapsed HCL.
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
Clinical, Review, Journal: Moxetumomab pasudotox-tdfk for relapsed/refractory hairy cell leukemia: a review of clinical considerations. (Pubmed Central) - Apr 24, 2020
Further clinical research is required to answer these questions and to discover other drugs effective in the treatment of relapsed HCL. Clinicians providing care for patients receiving moxetumomab pasudotox-tdfk should be aware of the strategies required for safe administration, including the management of serious adverse events.
- |||||||||| Leustatin (cladribine) / J&J, Rituxan (rituximab) / Roche, Biogen, Zenyaku Kogyo
Journal, IO Biomarker: No Loose Ends: A Review of the Pharmacotherapy of Hairy Cell and Hairy Cell Leukemia Variant. (Pubmed Central) - Apr 16, 2020
HCL and HCLv are uncommon lymphoid neoplasms that lead to a characteristic constellation of symptoms. The emergence of PAs and novel targeted agents have improved the likelihood and durability of responses for these patients.
- |||||||||| Leustatin (cladribine) / J&J, Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Rituxan (rituximab) / Roche, Biogen, Zenyaku Kogyo
Journal: Moxetumomab pasudotox for the treatment of hairy cell leukemia. (Pubmed Central) - Apr 1, 2020
The drug has been approved in 2018 by the FDA for the treatment of patients with relapsed/refractory HCL who had at least two prior systemic therapies including at least one purine nucleoside analog. Expert opinion: The use of moxetumomab pasudotox is a promising new strategy for the treatment of HCL.
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
Industrial Biotechnology Award: Development and Scale-Up of the Commercial Fed Batch Refolding Process for Lumoxiti, an anti-CD22 Two Chain Immunotoxin (Independence Ballroom A/B, Philadelphia 201 Hotel) - Feb 13, 2020 - Abstract #ACSSp2020ACS_Sp_17408;
Results from the 950L commercial scale refolding process are provided, demonstrating a greater than fivefold improvement in volumetric productivity compared to the clinical process. Lastly, several novel challenges that arose during late stage development are discussed including identification and control of low level expression of endogenous DE3 bacteriophage with a recA deficient E.coli host strain, as well as validation strategy for a process where the two polypeptide chains comprising Lumoxiti are expressed and recovered in separate fermentation unit operations.
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca
Enrollment open: PROXY: US Post-Marketing Safety Study of Moxetumomab Pasudotox-tdfk (LUMOXITI) (clinicaltrials.gov) - Dec 19, 2019
P=N/A, N=80, Recruiting,
Lastly, several novel challenges that arose during late stage development are discussed including identification and control of low level expression of endogenous DE3 bacteriophage with a recA deficient E.coli host strain, as well as validation strategy for a process where the two polypeptide chains comprising Lumoxiti are expressed and recovered in separate fermentation unit operations. Not yet recruiting --> Recruiting
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
Journal: Moxetumomab pasudotox: A first-in-class treatment for hairy cell leukemia. (Pubmed Central) - Nov 22, 2019
Common adverse effects are reviewed, and management strategies for select adverse effects are suggested. Implications for contemporary practitioners are also provided, as use of this novel agent is likely to increase as follow-up studies are reported.
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate, Rituxan (rituximab) / Roche, Biogen
Moxetumomab Pasudotox-Tdfk in Heavily Pretreated Patients with Relapsed/Refractory Hairy Cell Leukemia (HCL): Long-Term Follow-up from the Pivotal Phase 3 Trial (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3988;
P3
Eligible patients had received ≥ 2 prior systemic therapies, including ≥ 2 courses of a purine nucleoside analog (PNA) or 1 course of a PNA followed by ≥ 1 course of rituximab or a BRAF inhibitor...Based on primary and follow-up analyses of serum creatinine, there was no decline in renal function over time; 12 months post-treatment all mean (SD) serum creatinine laboratory values stayed within normal limits, which suggests current management strategies for HUS (oral hydration, i.v. fluid supplementation on the day of infusion, and the use of dexamethasone) are adequate...Moxetumomab pasudotox-tdfk treatment was associated with a manageable safety profile. Moxetumomab pasudotox-tdfk achieved a high rate of durable responses, demonstrating the ability to achieve MRD negativity in heavily pretreated patients with HCL.
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
Challenges In Management Of Hairy Cell Leukemia In 2019 (W307, Level 3 (Orange County Convention Center)) - Oct 27, 2019 - Abstract #ASH2019ASH_33;
Furthermore, most physicians will have limited experience in treating patients with moxetumomab pasudotox-tdfk, a drug approved by the FDA in 2018 for patients with relapsed or refractory HCL...Adequate time will be provided for questions and participation from the audience. Sponsor: Innate Pharma
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca
Journal: Hairy cell leukemia (Pubmed Central) - Sep 26, 2019
A multidisciplinary discussion is always necessary. In complex cases, expert advice is desirable.
- |||||||||| Rituxan (rituximab) / Roche, Biogen
Recombinant immunotoxins for hematologic malignancies (Level 3 - Ballroom C) - Sep 18, 2019 - Abstract #AACRNCIEORTC2019AACR_NCI_EORTC_566;
Recombinant immunotoxins are similar to but distinct from growth-factor fusions toxins like denileukin diftitox and Tagraxofusp, FDA-approved in 1999 and 2018, respectively...Anti-CD25 recombinant immunotoxin LMB-2 was active in several hematologic malignancies, notably hairy cell leukemia (HCL) and adult T-cell leukemia (ATL)...Improved targeting of HCL was achieved with anti-CD22 recombinant immunotoxin Moxetumomab Pasudotox (Moxe) that was stabilized with a disulfide bond in the Fv and has a high affinity for CD22...Molecular remissions assessed by blood analysis may be useful to determine the number of cycles of Moxe to administer to achieve long-term CR or possibly cure. To achieve molecular remissions with fewer cycles, Moxe is being tested with rituximab to facilitate tumor reduction and decrease anti-drug antibody formation.
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca
Clinical, Journal: Moxetumomab Pasudotox: First Global Approval. (Pubmed Central) - Aug 1, 2019
This article summarizes the milestones in the development of moxetumomab pasudotox leading to this first approval for the treatment of adults with relapsed or refractory hairy cell leukaemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analogue. Development of moxetumomab pasudotox for non-Hodgkin's lymphoma, chronic lymphocytic leukaemia and precursor cell lymphoblastic leukaemia/lymphoma was discontinued.
- |||||||||| Herceptin (trastuzumab) / Roche, Ultomiris IV (ravulizumab IV) / Alexion Pharma
Journal: Antibodies to watch in 2019. (Pubmed Central) - Aug 1, 2019
In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019...Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.
- |||||||||| Rituxan (rituximab) / Roche, Biogen
Journal, IO Biomarker: New treatment options in hairy cell leukemia with focus on BRAF inhibitors. (Pubmed Central) - Jun 22, 2019
Identification of the BRAF-V600E kinase mutation as the genetic cause of HCL has opened the way, in the relapsed/refractory experimental setting, to targeted and non-myelotoxic effective strategies that are based on inhibition of BRAF with vemurafenib, co-inhibition of BRAF and its target MEK with dabrafenib and trametinib, and BRAF inhibition with vemurafenib combined with anti-CD20 immunotherapy. In particular, vemurafenib plus rituximab is emerging as a short, safe, chemotherapy-free regimen able to induce deep complete remissions in most HCL patients refractory to, or relapsed multiple times, after chemo(immuno)therapy.
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca
Trial completion, Metastases: PLAIT: Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia (clinicaltrials.gov) - Jun 4, 2019
P3, N=80, Completed,
In particular, vemurafenib plus rituximab is emerging as a short, safe, chemotherapy-free regimen able to induce deep complete remissions in most HCL patients refractory to, or relapsed multiple times, after chemo(immuno)therapy. Active, not recruiting --> Completed
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca, Innate
Journal: Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia. (Pubmed Central) - May 24, 2019
Treatment-related serious AEs of hemolytic uremic syndrome (7.5%) and capillary leak syndrome (5%) were reversible and generally manageable with supportive care and treatment discontinuation (6 patients; 7.5%). Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability.
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca
Trial completion date, Metastases: PLAIT: Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia (clinicaltrials.gov) - Dec 20, 2018
P3, N=80, Active, not recruiting,
Moxetumomab pasudotox treatment achieved a high rate of independently assessed durable response and MRD eradication in heavily pretreated patients with HCL, with acceptable tolerability. Trial completion date: Dec 2018 --> May 2019
- |||||||||| Journal: Update on hairy cell leukemia. (Pubmed Central) - Sep 28, 2018
Rituximab has limited activity as a single agent but achieves high complete remission rates without minimal residual disease when combined with purine analogues, albeit with chemotherapy-associated toxicity. Investigational nonchemotherapy options include moxetumomab pasudotox, which targets CD22; vemurafenib or dabrafenib, each of which targets the BRAF V600E protein; trametinib, which targets mitogen-activated protein kinase enzyme (MEK); and ibrutinib, which targets Bruton tyrosine kinase (BTK).
- |||||||||| Review, Journal: New monoclonal antibodies for the treatment of acute lymphoblastic leukemia. (Pubmed Central) - Jul 19, 2017
Inotuzumab ozogamicin, an anti-CD22 antibody, alone and in combination with chemotherapy has been promising in relapsed and refractory B-cell ALL. The effectiveness and safety of several newer monoclonal antibodies including ofatumumab, obinutuzumab, epratuzumab, denintuzumab mafodotin and moxetumomab pasudotox as single agents or in combination with a chemotherapeutic back bone are currently under investigation.
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca
Trial termination, Trial primary completion date: A Phase I, Multicenter, Dose Escalation Study of CAT-8015 in Participants With Chronic Leukemia (clinicaltrials.gov) - Jul 6, 2017
P1, N=11, Terminated,
The effectiveness and safety of several newer monoclonal antibodies including ofatumumab, obinutuzumab, epratuzumab, denintuzumab mafodotin and moxetumomab pasudotox as single agents or in combination with a chemotherapeutic back bone are currently under investigation. Suspended --> Terminated | Trial primary completion date: Jan 2010 --> Apr 2008; The study is terminated early due to unavailability of investigational product.
- |||||||||| Lumoxiti (moxetumomab pasudotox) / AstraZeneca
Trial completion, Enrollment change, Trial primary completion date: Study of Moxetumomab Pasudotox in Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov) - Apr 17, 2017
P1/2, N=16, Completed,
Suspended --> Terminated | Trial primary completion date: Jan 2010 --> Apr 2008; The study is terminated early due to unavailability of investigational product. Active, not recruiting --> Completed | N=60 --> 16 | Trial primary completion date: Dec 2018 --> Apr 2017
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