Delving into the Latest Updates on Fotemustine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(+-)-Diethyl (1-(3-(2-chloroethyl)-3-nitrosoureido)ethyl)phosphonate, Diethyl-1-(3-(2-chloroethyl)-3-nitrosoureido)ethylphosphonate, Fotemustine (INN/BAN)

+ [8]

Target

DNA

Mechanism

DNA inhibitors(DNA inhibitors), DNA alkylating agents

Therapeutic Areas

NeoplasmsNervous System DiseasesSkin and Musculoskeletal Diseases

Active Indication

MelanomaBrain Cancer

Inactive Indication

Non-Small Cell Lung Cancer

Originator Organization-

Active Organization

Les Laboratoires Servier SAS

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

NZ (11 Dec 1991),

Melanoma

Regulation-

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Structure

Molecular FormulaC9H19ClN3O5P

InChIKeyYAKWPXVTIGTRJH-UHFFFAOYSA-N

CAS Registry92118-27-9

The purpose of this study is to evaluate the activity of Vemurafenib in combination with Fotemustine in Patients with unresectable Stage IV melanoma harboring V600 BRAF mutation who recurred while in treatment with Vemurafenib. In addition the feasibility and safety profile of prolonging treatment of this drugs combination will be assessed.

Start Date01 Feb 2013

Sponsor / Collaborator

Istituto Nazionale Dei Tumori

EUCTR2012-004301-27-IT / Not yet recruitingPhase 3IIT

A randomized, Phase III study of Fotemustine versus the Combination of Fotemustine and Ipilimumab in Patients with Metastatic Melanoma with brain metastasis - NIBIT-M2

Start Date08 Nov 2012

Sponsor / Collaborator-

100 Clinical Results associated with Fotemustine

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100 Translational Medicine associated with Fotemustine

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100 Patents (Medical) associated with Fotemustine

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456

Literatures (Medical) associated with Fotemustine

01 Mar 2024·European Journal of Cancer

Nivolumab plus ipilimumab in melanoma patients with asymptomatic brain metastases: 7-year outcomes and quality of life from the multicenter phase III NIBIT-M2 trial

Article

Author: Maio, Michele ; Guida, Michele ; Del Vecchio, Michele ; Ferrucci, Pier Francesco ; Marchetti, Paolo ; Di Giacomo, Anna Maria ; Amato, Giovanni ; Quaglino, Pietro ; Camerini, Roberto ; Simonetti, Elena ; Mandalà, Mario ; Santangelo, Federica ; Chiarion-Sileni, Vanna ; Valente, Monica ; Covre, Alessia ; Giannarelli, Diana ; Calabrò, Luana ; Guidoboni, Massimo

BACKGROUNDThe primary analysis of the phase III NIBIT-M2 study showed a 41% 4-year overall survival (OS) of melanoma patients with asymptomatic brain metastases treated with ipilimumab plus nivolumab.METHODSHere, we report the 7-year efficacy outcomes and the Health-Related Quality of Life (HRQoL) analyses of the NIBIT-M2 study.RESULTSAs of May 1, 2023, at a median follow-up of 67 months (mo), the median OS was 8.5 (95% CI: 6.6-10.3), 8.2 (95% CI: 2.1-14.3) and 29.2 (95% CI: 0-69.9) mo for the fotemustine (F) Arm A, ipilimumab plus fotemustine Arm B, and ipilimumab plus nivolumab Arm C, respectively. The 7-year OS rate was 10.0% (95% CI: 0-22.5) in Arm A, 10.3% (95% CI: 0-22.6) in Arm B, and 42.8% (95% CI: 23.4-62.2) in Arm C. HRQoL was preserved in all treatment arms. Most functional scales evaluated from baseline to W12 were preserved, with a lower mean score decrease for EORTC Quality of Life Questionnaire (QLQ)-C30 and an increase for EORTC QLQ-Brain neoplasm (BN20) in patients receiving ipilimumab plus nivolumab.CONCLUSIONSWith the longest follow-up available to date in melanoma patients with asymptomatic brain metastases, the NIBIT-M2 study continues to show persistent therapeutic efficacy of I ipilimumab plus nivolumab while preserving HRQoL.

02 Nov 2023·Immunopharmacology and Immunotoxicology

Efficacy and safety of the combined use of ipilimumab and nivolumab for melanoma patients with brain metastases: a systematic review and meta-analysis

Review

Author: Yang, Yuyan ; Su, Mengmeng ; Wang, Peng

CONTEXTImmune checkpoint inhibitors have advanced immunotherapy for melanoma patients.Objective: This study evaluates efficacy and safety of ipilimumab and nivolumab combination (IN) for melanoma brain metastases (MBM) patients.MATERIALS AND METHODSLiterature search was conducted in electronic databases and studies were included if they reported efficacy and safety of IN in MBM patients or prognostic information related to brain metastases. Outcomes evaluated were objective response rate (ORR), complete remission/stable disease/progressive disease rates, progression-free survival (PFS), overall survival (OS), incidence rates of adverse events, and hazard ratios of disease progression or mortality between IN-treated patients with and without brain metastasis.RESULTSIntracranial ORR was higher in IN-treated MBM patients than with control therapies (nivolumab or ipilimumab plus fotemustine). IN treatment led to longer PFS and OS in than control treatments. Five-year OS of IN-treated MBM patients was up to 51% compared to 34% for nivolumab. Outcomes were better for treatment naïve and asymptomatic patients. Whereas many studies reported significantly higher mortality or progression risk with IN treatment in MBM patients compared to non-MBM melanoma patients, many others did not find this risk significant. Incidence of grade 3/4 adverse events in IN-treated MBM patients was: diarrhea or colitis (16%), hepatitis (15%), rash (8%), increased alanine transaminase (8%), increased aspartate aminotransferase (7%), increased lipase (6%), increased amylase (4%), fatigue (3%), hypophysitis (2%), pneumonitis (2%), headache (2%), nausea or vomiting (1%), and neutropenia (1%).CONCLUSIONIN is an efficacious and safer treatment option for MBM patients, especially for asymptomatic and treatment naïve patients.

23 Feb 2023·Leukemia & Lymphoma

Fotemustine, etoposide, cytarabine, and cyclophosphamide (FEAC) conditioning regimen for autologous stem cell transplantation in lymphoma

Article

Author: Zhang, Lei ; Yan, Jiaqin ; Zhou, Zhiyuan ; Yu, Hui ; Wang, Xinhua ; Zhang, Mingzhi ; Sun, Zhenchang ; Lin, Meng ; Chang, Yu ; Li, Ling ; Shi, Cunzhen ; Nan, Feifei ; Zhang, Xudong ; Li, Xin ; Zhu, Linan ; Fu, Xiaorui ; Wu, Xiaolong

To investigate the efficacy and safety of the FEAC (fotemustine, etoposide, cytarabine, and cyclophosphamide) conditioning regimen for the treatment of lymphoma, we retrospectively analyzed the records of 76 Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) patients who underwent autologous stem cell transplantation (ASCT) after the FEAC conditioning regimen. Their survival, as well as the clinical efficacy, hematopoietic engraftment time, and toxicity, were analyzed. One patient died of severe pulmonary infection, and the transplant-related mortality (TRM) was 1.3% (1/76). Hematopoietic engraftment was achieved successfully in the remaining 75 patients. The median times of neutrophil and platelet engraftment were 11 d (6-21 d) and 13 d (8-24 d), respectively. The 2-year progression-free survival (PFS) rate was 69.1%, and the 2-year overall survival (OS) rate was 84.2%. FEAC conditioning regimen has acceptable toxicity, and the prognosis of patients is good, making it a feasible alternative to the BEAM regimen for ASCT.

100 Deals associated with Fotemustine

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External Link

KEGG	Wiki	ATC	Drug Bank
D07255	Fotemustine	L01AD05	DB04106

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Brain Cancer	CN	Les Laboratoires Servier SAS	-
Melanoma	CN	Les Laboratoires Servier SAS	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Preclinical	FR	-	-
Non-Small Cell Lung Cancer	Preclinical	GB	-	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NIBIT-M2 (ESMO2023)	Phase 3	Brain metastases	80	Fotemustine	(nrdskhafcz) = wrtfytkdez quxauhdnud (awmtwwbpoe, 6.6 - 10.3) View more	-	21 Oct 2023
				Ipilimumab+Fotemustine	(nrdskhafcz) = oibrdtjclp quxauhdnud (awmtwwbpoe, 2.1 - 14.3) View more
ASCO2022	Not Applicable	Recurrent Glioblastoma	42	Fotemustine and Bevacizumab	zxxgdyntza(irvnizvdof) = An increase in hematologic adverse events stands out in our pts hmzmnjzwxf (soecsxykiz )	-	02 Jun 2022
NCT01359956 (SICOG 0109, CTgov)	Phase 3	Melanoma recurrent	269	Interferon+Dacarbazine+Fotemustine (Fotemustine/Dacarbazine/Interferon + Fotemustine/Dacarbazine)	fdlkbzestj(lzivsfaixi) = wwxyitmewr ehpbdzhhzn (rhogwlzwpc, zjirfxtskc - vttymspizn) View more	-	13 Nov 2020
				Interferon+Dacarbazine (Dacarbazine/Interferon + Dacarbazine)	fdlkbzestj(lzivsfaixi) = xnpcfpyjvc ehpbdzhhzn (rhogwlzwpc, mgarfeuzbe - hxxjkdibkw) View more
NCT02460068 (NIBIT-M2, ESMO2020) Manual	Phase 3	Metastatic melanoma First line	76	fotemustine	(mrewvktwnp) = innkyzunis qtzniriquv (eehvksenqw, 4.8 - 12.2) View more	Positive	18 Sep 2020
				ipilimumab+fotemustine	(mrewvktwnp) = dhmnjdyyfq qtzniriquv (eehvksenqw, 2.0 - 14.3) View more
NCT01960192 (Pubmed \| J Neurooncol) Manual	Phase 2	Primary Central Nervous System Lymphoma BCL6 Overexpression	49	Fotemustine+teniposide+dexamethasone	(wokqshvmdj) = wfgkjqbjhk trbkrhbnvr (ruwkzsalci ) View more	Positive	01 Nov 2018
				methotrexate+cytarabine	(wokqshvmdj) = vcjafdrcum trbkrhbnvr (ruwkzsalci ) View more
NCT02843386 (ASCO2017) Manual	Phase 3	Uveal Melanoma Adjuvant	244	fotemustine	(yxxjikiibj) = eijaqcxinl uqgolzgzvo (nkqrrhvthh ) View more	Negative	04 Jun 2017
				surveillance	(yxxjikiibj) = nyzvjhyofn uqgolzgzvo (nkqrrhvthh )
NCT01474239 (AVAREG, Pubmed \| Neuro Oncol)	Phase 2	Recurrent Glioblastoma	91	Bevacizumab	lnnjyybihh(tuvxfckwvk) = yehnlhdopo yopuxleqlc (igbeqgpbfv, 48.4 - 74.5) View more	Positive	01 Sep 2016
				Fotemustine	lnnjyybihh(tuvxfckwvk) = rrssvlznao yopuxleqlc (igbeqgpbfv, 54.1 - 87.7) View more
NCT01983124 (Pubmed) Manual	Phase 2	BRAF V600 mutation-positive Melanoma BRAF V600 Mutation	31	vemurafenib+fotemustine	(mckjrxdace) = iycuaavxxx ehwzuemrby (cokrawedol ) View more	Positive	13 Jul 2016
IMAGE study (Pubmed \| Cancer Med)	Not Applicable	Melanoma Second line	177	Fotemustine	(bzzifilmad) = ocjdxqiwve dsmkuxdhnd (rykivetigp ) View more	-	01 Jul 2016
NCT01474239 (AVAREG \| AVAREG (ML25739), CTgov)	Phase 2	Glioblastoma Multiforme \| Recurrent Glioblastoma	91	Bevacizumab (Bevacizumab)	tpvnfvqicq(dylzzzfdev) = ocgzyqjplw iojftkjpmn (rgdvcritwg, yjwruzrqmu - nuzhaqthhp) View more	-	07 Aug 2015
				Fotemustine (Fotemustine)	tpvnfvqicq(dylzzzfdev) = yadhxqvftc iojftkjpmn (rgdvcritwg, huycllpgiu - oxttqsfrwr) View more