Delving into the Latest Updates on Lipegfilgrastim with Synapse

Overview

Basic Info

Drug Type

Colony-stimulating factors

Synonyms

GlycoPEG-GCSF, GlycoPEGylated G-CSF, GlycoPEGylated granulocyte colony-stimulating factor

+ [7]

Target

CSF-3R

Action

agonists

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Febrile NeutropeniaNeutropenia

Inactive Indication

Peripheral Primitive Neuroectodermal TumorsRhabdomyosarcoma

Originator Organization

Teva Pharmaceutical Industries Ltd.

Active Organization

Teva Pharmaceuticals Australia Pty LtdTeva Pharmaceuticals Europe BVTeva-Handok Pharma Co., Ltd.

Inactive Organization

Merckle GmbH

Drug Highest PhaseApproved

First Approval Date

European Union (25 Jul 2013),

Febrile NeutropeniaNeutropenia

Regulation-

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Structure/Sequence

Sequence Code 4190

Source: *****

The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells for autologous stem cell transplantation in patients with lymphoma and multiple myeloma.

Start Date01 Jul 2017

Sponsor / Collaborator

Sheba Medical Center

EUCTR2015-000087-34-BE

/ Not yet recruitingPhase 2

An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 µg/kg Body Weight in Comparison to Filgrastim 5 µg/kg Body Weight in Pediatric Patients Diagnosed with Ewing Family of Tumors or Rhabdomyosarcoma Receiving Chemotherapy

Start Date24 Nov 2016

Sponsor / Collaborator

Merckle GmbH

100 Clinical Results associated with Lipegfilgrastim

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100 Translational Medicine associated with Lipegfilgrastim

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100 Patents (Medical) associated with Lipegfilgrastim

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59

Literatures (Medical) associated with Lipegfilgrastim

01 Nov 2023·Clinical Lymphoma Myeloma and Leukemia

Loss of CD34+ Cells and Effect of the Number of Viable Cryopreserved CD34+ Cells in the Infused Blood Grafts on Hematologic Recovery, Progression-Free Survival and Overall Survival in NHL Patients After Autologous Stem Cell Transplantation

Article

Author: Penttilä, Karri ; Jantunen, Esa ; Valtola, Jaakko ; Kuittinen, Outi ; Kuitunen, Hanne ; Partanen, Anu ; Mäntymaa, Pentti ; Pyörälä, Marja ; Turunen, Antti ; Vasala, Kaija ; Kuittinen, Taru ; Varmavuo, Ville ; Pelkonen, Jukka

PATIENTSThis post-hoc study aimed to find out factors affecting graft viable CD34⁺ cell loss during processing and cryopreservation in 129 non-Hodgkin lymphoma (NHL) patients receiving autologous stem cell transplantation (auto-SCT) and the impact of a low (< 2.0 × 10⁶/kg, group A) and a decent number (≥ 2 × 10⁶/kg, group B) of viable CD34⁺ cells infused on the hematologic recovery, progression-free survival (PFS) and overall survival (OS) after auto-SCT.RESULTSThe median loss of viable CD34⁺ cells during cryopreservation was higher in group A (47% vs. 19%, p < .001). A higher yield of CD34⁺ cells at the first apheresis in group B (p = .002) was linked with greater loss of viable graft CD34⁺ cells after cryopreservation. Filgrastim (FIL) use for mobilization seemed to associate with higher viable CD34⁺ cell loss compared to pegfilgrastim (PEG) or lipegfilgrastim (LIPEG) in both groups (in group A FIL 66 vs. PEG 35%, p = .006; in group B FIL 37 vs. PEG 15 vs. LIPEG 13%, p < .001). Hematologic recovery after auto-SCT was faster in group B. Neither viable CD34⁺ cell loss during storage nor viable CD34⁺ cell number < 2.0 × 10⁶/kg infused affected on PFS or OS.CONCLUSIONSG-CSF type used in mobilization and mobilization capacity were found to correlate with viable CD34⁺ cell loss during processing and storage. Most importantly, low infused viable CD34⁺ cell count did not seem to impact on PFS or OS.

01 Jan 2023·Cancer Control

Outcome and Cost-Effectiveness Analysis of Long-acting G-CSF as Primary Prophylaxis of Neutropenia Induced by Chemotherapy in Breast Cancer Patients, From a Retrospective Study

Article

Author: Ma, Peizhi ; Wang, Yaqin ; Zhao, Chenglong ; Jiang, Dandan

Purpose This retrospective analysis aimed to evaluate the clinical outcomes and cost-effectiveness of long-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia caused by chemotherapy for breast cancer. Methods Patients with breast cancer who received long- or short-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia were enrolled in this study, and incidences of neutropenia were compared between two groups. A decision-analytic and a Markov model were used to compare the health benefits and costs of utilizing long- vs short-acting granulocyte-colony stimulating factor as the primary prophylaxis from the perspective of the Chinese health service system. Subsequently, one-way deterministic and probabilistic sensitivity analyses were conducted. The incremental cost-effectiveness ratios were calculated in baseline and sensitivity analyses. Results Patients receiving long-acting granulocyte-colony stimulating factor as the primary prophylaxis of chemotherapy-induced neutropenia experienced a significant lower incidence of this adverse event, compared with the short-acting one for 2 to 7 days. The outcomes of baseline analysis indicated that long-acting granulocyte-colony stimulating factor had a gain of 0.08 quality-adjusted life years and costed $149 more than the short-acting one, yielding an incremental cost-effectiveness ratio of $1792 per quality-adjusted life year. The sensitivity analysis proved the stability of our models and economic efficiency of long-acting granulocyte-colony stimulating factor. Conclusions Patients receiving long-acting granulocyte-colony stimulating factor as primary prophylaxis of neutropenia experienced lower risk of this event compared with those underusing short-acting one. The long-acting granulocyte-colony stimulating factor may be a more cost-effective strategy for primary prophylaxis of neutropenia than short-acting one, considering the Chinese willingness-to-pay threshold of $12158.6 per quality-adjusted life year.

02 Dec 2022·Current Medical Research and Opinion

Prophylaxis of chemotherapy-induced neutropenia with lipegfilgrastim in patients with lung cancer: final results from the non-interventional study NADIR

Article

Author: Schulz, Holger ; Hipp, Joachim ; Losem, Christoph ; Frost, Nikolaj ; Lück, Andreas ; Matillon, Christiane D. ; Harde, Johanna ; Fietz, Thomas ; Potthoff, Karin ; Groschek, Matthias ; Kretzschmar, Albrecht ; Niemeier, Beate ; Weide, Rudolf ; Geßner, Christian ; Grebhardt, Sina ; Eschenburg, Henning

OBJECTIVEReal-world evidence on the application of the granulocyte colony-stimulating factor lipegfilgrastim for the reduction of chemotherapy-induced neutropenia and febrile neutropenia (FN) is limited. The NADIR study aimed to evaluate effectiveness and safety of lipegfilgrastim as primary or secondary prophylaxis in patients with lung cancer undergoing chemotherapy in routine clinical practice.METHODSThe non-interventional study NADIR (German Clinical Trials Register (DRKS) Number DRKS00005711) enrolled 156 patients with small-cell lung cancer (SCLC) and 145 patients with non-small-cell lung cancer (NSCLC), who received lipegfilgrastim during chemotherapy. Primary endpoint was the incidence of severe neutropenia (CTCAE grade 3/4) and FN. The analysis was stratified for age groups (≤65 years vs. >65 years).RESULTSApproximately half of the patients were aged >65 years (SCLC 54.5%; NSCLC 46.9%). Intention of antineoplastic treatment was mostly palliative (SCLC 89.1%; NSCLC 73.1%). Patients with high FN risk (SCLC 44.9%; NSCLC 28.3%) mostly received lipegfilgrastim for primary prophylaxis (SCLC 81.4%; NSCLC 70.7%). FN was reported in 1.9% SCLC and 1.4% NSCLC patients. At least one severe neutropenia was documented in 30.1% SCLC and 17.9% NSCLC patients. For NSCLC patients aged >65 years, less severe neutropenia was reported as compared to younger patients (14.7% vs. 20.8%). Lipegfilgrastim-related adverse events were reported in 10.3% SCLC and 7.7% NSCLC patients.CONCLUSIONLipegfilgrastim in routine clinical practice of patients with lung cancer showed similar effectiveness and safety as compared to the pivotal trial. Interestingly, in older patients severe neutropenia was reported less frequently. While most patients with high FN risk received lipegfilgrastim for primary prophylaxis as recommended, there are still 20-30% of patients at high FN risk without primary prophylaxis who could benefit from better adherence to guidelines.

100 Deals associated with Lipegfilgrastim

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External Link

KEGG	Wiki	ATC	Drug Bank
D10242	Lipegfilgrastim	L03AA14	DB13200

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Febrile Neutropenia	Liechtenstein	Teva Pharmaceuticals Europe BV	25 Jul 2013
Febrile Neutropenia	Iceland	Teva Pharmaceuticals Europe BV	25 Jul 2013
Febrile Neutropenia	European Union	Teva Pharmaceuticals Europe BV	25 Jul 2013
Febrile Neutropenia	Norway	Teva Pharmaceuticals Europe BV	25 Jul 2013
Neutropenia	Liechtenstein	Teva Pharmaceuticals Europe BV	25 Jul 2013
Neutropenia	Iceland	Teva Pharmaceuticals Europe BV	25 Jul 2013
Neutropenia	Norway	Teva Pharmaceuticals Europe BV	25 Jul 2013
Neutropenia	European Union	Teva Pharmaceuticals Europe BV	25 Jul 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral Primitive Neuroectodermal Tumors	Phase 1	Poland	Merckle GmbH	01 Jul 2012
Rhabdomyosarcoma	Phase 1	Czechia	Merckle GmbH	01 Jul 2012
Rhabdomyosarcoma	Phase 1	Russia	Merckle GmbH	01 Jul 2012
Rhabdomyosarcoma	Phase 1	Bulgaria	Merckle GmbH	01 Jul 2012
Rhabdomyosarcoma	Phase 1	Poland	Merckle GmbH	01 Jul 2012
Peripheral Primitive Neuroectodermal Tumors	Discovery	Hungary	Merckle GmbH	01 Jul 2012
Peripheral Primitive Neuroectodermal Tumors	Discovery	Ukraine	Merckle GmbH	01 Jul 2012
Peripheral Primitive Neuroectodermal Tumors	Discovery	Bulgaria	Merckle GmbH	01 Jul 2012
Peripheral Primitive Neuroectodermal Tumors	Discovery	Russia	Merckle GmbH	01 Jul 2012
Peripheral Primitive Neuroectodermal Tumors	Discovery	Czechia	Merckle GmbH	01 Jul 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


GOA (EBMT2020)	Not Applicable	Non-Hodgkin Lymphoma	104	Pegfilgrastim 6 mg	kxlxovluhu(ntzwypdtsu) = xvoizwdekz nzsulbffcp (bwvrambanh ) View more	-	29 Aug 2020
GOA (EBMT2020)	Not Applicable	Non-Hodgkin Lymphoma	104	Lipegfilgrastim 6 mg	kxlxovluhu(ntzwypdtsu) = ukasjctysl nzsulbffcp (bwvrambanh ) View more	-	29 Aug 2020
NADENS (ESMO2019)	Not Applicable	Breast Cancer	328	Lipegfilgrastim	(bpbmmlmchw) = caqfoxitwa kvcayciclk (busqrubeks ) View more	-	28 Sep 2019
NCT02488382 (EHA2019)	Phase 1/2	Multiple Myeloma	24	Lonquex	(uccmicessm) = 13% wktvtgtixm (hofxtvzqei ) View more	-	15 Jun 2019
ESMO2018	Not Applicable	Chemotherapy-Induced Febrile Neutropenia	-	Lipegfilgrastim	(rqhzvdfycf) = pvufqrbwrg kgumjdnwsr (gdkiusdvrg ) View more	Positive	22 Oct 2018
EHA2017	Not Applicable	Lymphoma	249	Lipegfilgrastim	(zvweuiaztc) = ipaxhlklxu sdvfhbqwtn (ulphsenlog ) View more	Positive	18 May 2017
NCT01585649 (Pubmed \| Cancer Chemother Pharmacol) Manual	Phase 1	Peripheral Primitive Neuroectodermal Tumors \| Rhabdomyosarcoma	21	chemotherapy+lipegfilgrastim	(laxewcftbg) = 57% of patients; febrile neutropenia, leukopenia, neutropenia, and thrombocytopenia plgquiwsyl (asseztkpgj )	Positive	01 Jan 2017
ASCO2015	Not Applicable	Febrile Neutropenia	53	Pegfilgrastim	(zsritaplns) = dqpfmnomfd pyxxnzczrs (lybclujcvo ) View more	-	20 May 2015
ASCO2015	Not Applicable	Febrile Neutropenia	53	Lipegfilgrastim	(zsritaplns) = csnyvbfgem pyxxnzczrs (lybclujcvo ) View more	-	20 May 2015
ASCO2012	Not Applicable	Breast Cancer	-	Lipegfilgrastim 6 mg	(yqbdsiryfg) = czjaohmoac lurbeqmtfy (rexauqpzkn ) View more	Positive	20 May 2012
ASCO2012	Not Applicable	Breast Cancer	-	Pegfilgrastim 6 mg	(yqbdsiryfg) = ezrngktfty lurbeqmtfy (rexauqpzkn ) View more	Positive	20 May 2012
XM22-02-INT (ASCO2011)	Not Applicable	Breast Cancer	208	XM22 3mg	(mmplnygqgi) = xzjymbkdnd xyrhkhyfap (aoczkbloqj )	Positive	20 May 2011
XM22-02-INT (ASCO2011)	Not Applicable	Breast Cancer	208	XM22 4.5mg	(mmplnygqgi) = bdrpmruyev xyrhkhyfap (aoczkbloqj )	Positive	20 May 2011

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Lipegfilgrastim

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation