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- ||| Elzonris (tagraxofusp) / Stemline Therapeutics
3rd Pt Death Reported in SL-401 (vs IL-3 rec CD123) BPDCN & AML Trial [Mar 15, 2017] @ASHClinicalNews https://t.co/xfAkQjXJmG #BPDCN #leusm (Twitter) - Mar 2, 2020
- Elzonris (tagraxofusp) / Menarini
[VIRTUAL] BENEFICIAL OUTCOME OF ALLOGENEIC STEM CELL TRANSPLANTATION FOR BLASTIC PLASMACYTOID DENDRITIC CELL NEOPLASM (ePoster Area) - Feb 8, 2020 - Abstract #EBMT2020EBMT_866;
Recently, targeted therapy with Tagraxofusp (SL-401), an IL-3 fusion protein which binds to CD123, has proved its efficacy with an overall response rate (ORR) of 90% in 32 untreated and 67% in 15 previously treated BPDCN patients... Induction treatment with leukemia-like regimen and proceeding to allogeneic stem cell transplantation can prolong overall survival in Asian patients with BPDCN.
- | Elzonris (tagraxofusp) / Stemline Therapeutics
Review, Journal: Tagraxofusp, a novel CD123-directed cytotoxin to treat blastic plasmacytoid dendritic cell neoplasm. (Pubmed Central) - Feb 8, 2020
In this review, we examine the preclinical studies and phase I/II clinical studies that led to FDA approval of tagraxofusp, focusing on its molecular pharmacology, pharmacokinetics, efficacy and safety profile. We also discuss future directions regarding BPDCN management.
- ||| Elzonris (tagraxofusp) / Stemline Therapeutics
Amazing lecture on #BPDCN by @doctorpemm 👏🏻🤓 Very impressed by your enthusiastic and thoughtful way of presenting! 😁 And by the outstanding work to lead the approval of tagraxofusp, the first drug approved for this rare disease! 👍🏼🏆 (Twitter) - Feb 6, 2020
- || Elzonris (tagraxofusp) / Stemline Therapeutics
Tagraxofusp is a Novel Targeted Therapy Directed to CD123 https://t.co/r4JvkrePql (Twitter) - Jan 30, 2020
- || Folotyn (pralatrexate) / Aurobindo, Idhifa (enasidenib) / BMS, Elzonris (tagraxofusp) / Menarini, Nippon Shinyaku
Clinical, Journal: Multicenter Analysis of Outcomes in Blastic Plasmacytoid Dendritic Cell Neoplasm Offers a Pre-Targeted Therapy Benchmark. (Pubmed Central) - Jan 28, 2020
This study highlights poor outcomes for BPDCN patients in the modern era and the need for new treatments. Outcomes from ongoing clinical trials for BPDCN can be evaluated relative to this contemporary cohort.
- | Venclexta (venetoclax) / Roche, AbbVie, Elzonris (tagraxofusp-erzs) / Menarini
New P2 trial: NCI-2019-08358: Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (clinicaltrials.gov) - Jan 2, 2020
P2, N=40, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
- |||| Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical: #cardioonc peeps: anyone encounter cardiotox issues in pts getting tagraxofusp 4 blastic plasmacytoid dendritic cell neoplasm? Specifically atrial fibrillation? @NikhilBassiMD @CardioOncology @onco_cardiology @jelevenson @Dr_Mike_Fradley @avirupguha @OSUCardioOnc @DarrylLeong (Twitter) - Dec 21, 2019
- | Elzonris (tagraxofusp-erzs) / Menarini
Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Metastases: Study 0314: Tagraxofusp (SL-401) in Patients With CMML or MF (clinicaltrials.gov) - Dec 20, 2019
P2, N=130, Recruiting, Sponsor: Stemline Therapeutics, Inc.
Outcomes from ongoing clinical trials for BPDCN can be evaluated relative to this contemporary cohort. Phase classification: P1/2 --> P2 | N=100 --> 130 | Trial completion date: Dec 2019 --> Dec 2021 | Trial primary completion date: Dec 2019 --> Dec 2020
- ||| Elzonris (tagraxofusp) / Stemline Therapeutics
Do you see a role for SL-401 tagraxofusp/anti-CD123 in pDC-rich CMML? #HemepathJC @doctorpemm @lane_andy @TaylorJ_MD (Twitter) - Dec 20, 2019
- ||| Elzonris (tagraxofusp) / Stemline Therapeutics
#hemepathJC | Yes @sanamloghavi good q - as we presented at #ASH19 for SL401 in MF , this is indeed part of the hypothesis- b/c monocytes are CD-123 expressing ; also some datasets show that monocytes rich MF May have worse prognosis ; and in CMML again monocytes express CD123 (Twitter) - Dec 19, 2019
- | Elzonris (tagraxofusp) / Stemline Therapeutics
This is after relapse on tagraxofusp-erzs, right? $STML $IMGN (Twitter) - Dec 18, 2019
- ||| Jakafi oral (ruxolitinib) / Novartis, Incyte, Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical: Promising efficacy (and safety, phew) data from tagraxofusp+ruxolitinib aka “fuspolitinib”! (Twitter) - Dec 9, 2019
- ||||| Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical: Tagraxofusp (that’s a tongue twister) - initial results of Ph 1/2 trial in #MF by @doctorpemm - improvement in symptoms and spleen size, appears more active in pts with thrombocytopenia and monocytosis; one challenge is long term IV administration #ASH19 #mpnsm (Twitter) - Dec 9, 2019
- ||||| Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical: #ASH19 #MPNSM | @doctorpemm presenting SL-401 in MF. Encouraging spleen and symptom responses. Challenging agent to administer in this patient population. Potential to target those MF patients with monocyte-enriched phenotype - a high risk group. (Twitter) - Dec 9, 2019
- |||| Elzonris (tagraxofusp) / Stemline Therapeutics
Updated data on SL401 in MF by Dr. Pemmaraju. @doctorpemm #mpnsm (Twitter) - Dec 9, 2019
- ||||| Elzonris (tagraxofusp) / Stemline Therapeutics
Tagraxofusp from @Stemline targeting CD 123 with exciting activity in myelofibrosis! Approved in BPDCN, and other myeloid trials coming. Nice work @doctorpemm #ASH19 @MDAndersonNews @LeukemiaMDA (Twitter) - Dec 9, 2019
- ||||| Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical, P1/2 data: Join @doctorpemm for "Results from a Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Intermediate or Hi-Risk R/R Myelofibrosis," Session 634. Mon, Dec 9, 7-8:30AM, W304EFGH, Lvl 3 (Orange Co Conv Ctr) @LeukemiaMDA #ASH19 #ASH2019 (Twitter) - Dec 8, 2019
- ||||| Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical: @doctorpemm discusses tagraxofusp for R/R myelofibrosis, BPDCN patient characteristics and outcomes in the modern era and social media use amongst hematologists here at #ASH19 @VJHemOnc @ASH_hematology #HemeOnc #MPNsm @LeukemiaMDA (Twitter) - Dec 8, 2019
- ||||| Jakafi oral (ruxolitinib) / Novartis, Incyte, Elzonris (tagraxofusp) / Stemline Therapeutics
Is there a role for combination SL-401 and Ruxolitinib in advanced MPN? Come to Aishwarya Krishnan’s poster this afternoon to learn more. #mpnsm @sloan_kettering @Stemline @rosslevinemd (Twitter) - Dec 8, 2019
- || Elzonris (tagraxofusp) / Stemline Therapeutics
Elzonris in Europe? (Twitter) - Dec 7, 2019
- || Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical, Journal: Tagraxofusp: First Global Approval. (Pubmed Central) - Nov 29, 2019
A centralized registration application for the use of tagraxofusp in patients with BPDCN is under review in the EU. This article summarizes the milestones in the development of tagraxofusp leading to its first global approval for the treatment of BPDCN.
- | Elzonris (tagraxofusp) / Menarini
Review, Journal: Tagraxofusp, the first CD123-targeted therapy and first targeted treatment for blastic plasmacytoid dendritic cell neoplasm. (Pubmed Central) - Nov 27, 2019
Many patients treated with this agent were able to be bridged to stem cell transplantation, including older patients. In the future, combinations of tagraxofusp with other targeted agents will be explored.
- ||||| Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical: #ASH19 Oral Presentation | @doctorpemm et al Ph 1/2 #Tagraxofusp (SL-401) in Patients with Int-High Risk, R/R Myelofibrosis | @Vikas_Gupta_1 @AYACOUB7 @EuniceWangMD @JoeKhouryMD @mrinal90151372 | #MPNSM https://t.co/Ub1SyldcXC (Twitter) - Nov 18, 2019
- || Elzonris (tagraxofusp) / Stemline Therapeutics
@doctorpemm has a good treatment for BPDCN : Tagraxofusp ! (Twitter) - Nov 11, 2019
- ||| Elzonris (tagraxofusp) / Stemline Therapeutics
Tagraxofusp (antiCD123) in Blastic Plasmacytoid Dendritic-Cell Neoplasm | NEJM https://t.co/2MZEgwvqZi (Twitter) - Nov 7, 2019
- Elzonris (tagraxofusp) / Stemline Therapeutics
Discovery of Novel IL3RA (CD123) Isoforms By Long Read Transcriptomics, Heterogeneous Expression Among AML Patient Cohorts and the Implications for Anti-CD123 Therapeutics (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_6418;
As such, antibody-drug conjugates or CAR T cells against this antigen have been developed including tagraxofusp-erzs, recently approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)...In conclusion, changes in protein length and peptide sequence may affect the efficacy of therapeutic anti-CD123 approaches since some patients express alternative isoforms with a wide range of abundance . We anticipate that the computational and experimental pipeline used to discover and characterize these isoforms will be of high value in the study of many cell surface antigens with therapeutic potential.
- Clinical Profile of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate (ADC), in Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (Tangerine 3 (WF3-4), Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_5017;
The encouraging single agent activity and safety profile, along with supporting preclinical efficacy studies, have led to the subsequent development of IMGN632 as monotherapy in patients with R/R BPDCN and MRD+ AML, and in combination with azacitidine and/or venetoclax in patients with R/R and untreated AML. Figure 1.
- Elzonris (tagraxofusp) / Stemline Therapeutics
Results from a Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Intermediate, or High Risk, Relapsed/Refractory Myelofibrosis (W304EFGH, Level 3 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4762;
P1/2
Enrollment continues, and updated trial data will be presented . This clinical trial is registered at clinicaltrials.gov: NCT02268253.
- Elzonris (tagraxofusp) / Stemline Therapeutics, Pomalyst (pomalidomide) / BMS
Results from Phase 1/2 Trial of Tagraxofusp in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4340;
P1/2
Evidence of pDC suppression in peripheral blood and BM was observed in this patient population. 5 patients that received tagraxofusp and POM+DEX combination had PRs and decreases in pDC levels while on treatment with tagraxofusp.
- Jakafi oral (ruxolitinib) / Novartis, Incyte, Elzonris (tagraxofusp) / Stemline Therapeutics
Evaluation of Tagraxofusp (SL-401) Alone and in Combination with Ruxolitinib for the Treatment of Myeloproliferative Neoplasms (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_4155;
This is particularly the case for patients with progression to accelerated and blast-phase MPN . Here, we demonstrate that CD123 expression is evident in many such cases .
- Venclexta (venetoclax) / Roche, AbbVie, bortezomib / J&J, Generic mfg., Elzonris (tagraxofusp) / Stemline Therapeutics
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Commonly Presents in the Setting of Prior or Concomitant Hematologic Malignancies (PCHM): Patient Characteristics and Outcomes in the Rapidly Evolving Modern Targeted Therapy Era (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3899;
In this new era of novel treatments, it is important to note that pts with BPDCN with PCHM are quite commonly encountered, most commonly with prior or concomitant MDS or CMML. Etiologies for this are multifactorial and will be an important area of research for the field, and will include further investigation of shared stem origin of these associated hematologic malignancies, older age of pts with BPDCN, and presence of CHIP, and/or myeloid mutation markers in many pts with BPDCN, including those with skin-only BPDCN.
- IMGN632 / Jazz
A Phase I Study of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, and Other CD123-Positive Hematologic Malignancies (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_2156;
P1/2
Clinical results from this study and the design of the phase 1b/2 combination study are reported in separate abstracts. Clinical trial information: NCT03386513.
- | Elzonris (tagraxofusp) / Stemline Therapeutics, Ontak (denileukin diftitox) / Eisai, Dr. Reddy’s
Review, Journal: Targeted Diphtheria Toxin-Based Therapy: A Review Article. (Pubmed Central) - Nov 5, 2019
Despite some success with immunotoxins, suicide-gene therapy strategies, whereby controlled tumor-specific expression of DT is used for the eradication of malignant cells, are gaining prominence. The first part of this review focuses on DT-based immunotoxins, and it then discusses recent developments in tumor-specific expression of DT.
- | Elzonris (tagraxofusp) / Menarini, Nippon Shinyaku
Clinical, Journal: First pediatric experience of SL-401, a CD123-targeted therapy, in patients with blastic plasmacytoid dendritic cell neoplasm: report of three cases. (Pubmed Central) - Oct 29, 2019
Sl-401 was well tolerated and can produce a promising response. Further testing this agent in children is warranted.
- ||| Elzonris (tagraxofusp) / Stemline Therapeutics
Tagraxofusp in Blastic Plasmacytoid Dendritic-Cell Neoplasm [Apr 25, 2019] @doctorpemm @lane_andy et al. @NEJM https://t.co/C1ngrvmR9S #BPDCN #caxtx (Twitter) - Oct 25, 2019
- ||| Elzonris (tagraxofusp) / Stemline Therapeutics
3rd Pt Death Reported in SL-401 (vs IL-3 rec CD123) BPDCN & AML Trial [Mar 15, 2017] @ASHClinicalNews https://t.co/xfAkQkfkLg #BPDCN #leusm (Twitter) - Oct 25, 2019
- |||| Elzonris (tagraxofusp) / Stemline Therapeutics
Nice commentary (and very nice summary figure below!) by Lukasz Gondek from @hopkinskimmel in @jclinicalinvest re: our paper on tagraxofusp resistance in AML and BPDCN. https://t.co/nkaHR2noQV https://t.co/PiTSoQwZz9 (Twitter) - Oct 15, 2019
- || Elzonris (tagraxofusp) / Stemline Therapeutics
Tagraxofusp is a Novel Targeted Therapy Directed to CD123 https://t.co/WTLobfmSKO (Twitter) - Oct 13, 2019
- Elzonris (tagraxofusp) / Stemline Therapeutics
CD123+ Plasmacytoid Dendritic Cells from Systemic Sclerosis Patients Are Susceptible to the Cytotoxic Activity of Tagraxofusp, a CD123-Targeted Therapy (Hall B5) - Oct 7, 2019 - Abstract #ACRARHP2019ACR_2664;
These data present a novel approach of targeting pDCs in the treatment of SSc, and a clinical trial is under design. Document1 Figure 1: SSc pDC survival following 24 h incubation with tagraxofusp demonstrating a similar ED50 in both CpG-stimulated (red) and unstimulated (blue) pDCs (n=5) but no effect on B/T cells or monocytes (A).
- | Venclexta (venetoclax) / Roche, AbbVie, Elzonris (tagraxofusp) / Menarini, Nippon Shinyaku
Review, Journal: Recent developments in the treatment of blastic plasmacytoid dendritic cell neoplasm. (Pubmed Central) - Oct 5, 2019
Specifically in BPDCN, tagraxofusp was highly effective with a safety profile found to be acceptable overall, with the noted occurrence of capillary leak syndrome. Future directions in therapy approaches for patients with BPDCN will include the development of other CD123-targeted agents, agents targeting beyond CD123 and investigation of rational combination approaches of CD123-directed therapy with other therapies.
- |||| Elzonris (tagraxofusp) / Stemline Therapeutics
FDA event: With new oncology medication #FDA approvals, there are two brewing crises: 1) Costs! And lesser but just as important: 2) More unpronounceable tongue-twisters #tagraxofusp-erzs for #BPDCN. What are your #2 examples? @OphiraG @GlopesMd @VPrasadMDMPH @oncology_bg @drdonsdizon (Twitter) - Oct 5, 2019
- | Elzonris (tagraxofusp) / Menarini, Nippon Shinyaku
Clinical, Journal: The interleukin-3 receptor CD123 targeted SL-401 mediates potent cytotoxic activity against CD34CD123 cells from acute myeloid leukemia / myelodysplastic syndrome patients and healthy donors. (Pubmed Central) - Oct 4, 2019
In addition to primary samples, studies on normal cord blood and healthy marrow show that SL-401 has activity against normal hematopoietic progenitors. These findings indicate potential use of SL-401 as a "bridge-to-transplant" before allogeneic hematopoietic cell transplantation in acute myeloid leukemia / myelodysplastic syndrome patients.
- ||| Vyxeos (cytarabine/daunorubicin liposomal formulation) / Jazz, Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical: At our hospital, I've only seen Vyxeos given outpatient for that reason. I wonder if we'll see the same for tagraxofusp ... #HOJournalClub (Twitter) - Oct 3, 2019
- || Venclexta (venetoclax) / Roche, AbbVie, Elzonris (tagraxofusp) / Stemline Therapeutics
Agreed, would like to see results of venetoclax & venetoclax/tagraxofusp, however would expect much greater hematologic toxicity (Twitter) - Oct 3, 2019
- |||| Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical: I think the primary outcome of the Tagraxofusp study was response rate. I agree we need longer follow-up to evaluate survival endpoints. For fit patients who can tolerate intensive induction chemotherapy and transplant we really don’t know if it’s better #HOJournalClub (Twitter) - Oct 3, 2019
- || Elzonris (tagraxofusp) / Stemline Therapeutics
The response rates for SL-401 in the relapse setting after induction chemo (IC) was better than expected. So will give a better shot at that second chance. But if historical CR rates for IC are about the same, is it a better 1st line bridge? #HOJournalclub (Twitter) - Oct 3, 2019
- |||| Elzonris (tagraxofusp) / Stemline Therapeutics
Clinical: The latest #BPDCN #Tagraxofusp paper by @doctorpemm , @lane_andy @DrHKantarjian and others in @NEJM is the subject of discussion at #HOJournalclub tonight!! Tune in.... @LeukemiaMDA #leusm #hemepath (Twitter) - Oct 3, 2019
- |||| Elzonris (tagraxofusp) / Stemline Therapeutics
Tagraxofusp, the first CD123-targeted therapy and first targeted treatment for blastic plasmacytoid dendritic cell neoplasm | @minaseconomides @lane_andy Dr McCue @doctorpemm @LeukemiaMDA #BPDCN https://t.co/tc40Y8IrU9 (Twitter) - Sep 28, 2019