Last update 19 Jul 2024

Cemiplimab-RWLC

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
cemiplimab, Cemiplimab (Genetical Recombination)(JAN), 西米普利单抗
+ [4]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US), Breakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (AU), Paediatric investigation plan (EU)
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External Link

KEGGWikiATCDrug Bank
-Cemiplimab-RWLC

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Metastatic Carcinoma to the Uterine Cervix
EU
17 May 2023
Metastatic Carcinoma to the Uterine Cervix
IS
17 May 2023
Metastatic Carcinoma to the Uterine Cervix
LI
17 May 2023
Metastatic Carcinoma to the Uterine Cervix
NO
17 May 2023
Recurrent Cervical Cancer
EU
17 May 2023
Recurrent Cervical Cancer
IS
17 May 2023
Recurrent Cervical Cancer
LI
17 May 2023
Recurrent Cervical Cancer
NO
17 May 2023
Uterine Cervical Cancer
CA
25 Mar 2022
Advanced Skin Squamous Cell Carcinoma
EU
28 Jun 2019
Advanced Skin Squamous Cell Carcinoma
IS
28 Jun 2019
Advanced Skin Squamous Cell Carcinoma
LI
28 Jun 2019
Advanced Skin Squamous Cell Carcinoma
NO
28 Jun 2019
Basal Cell Carcinoma
EU
28 Jun 2019
Basal Cell Carcinoma
IS
28 Jun 2019
Basal Cell Carcinoma
LI
28 Jun 2019
Basal Cell Carcinoma
NO
28 Jun 2019
Locally Advanced Lung Non-Small Cell Carcinoma
EU
28 Jun 2019
Locally Advanced Lung Non-Small Cell Carcinoma
IS
28 Jun 2019
Locally Advanced Lung Non-Small Cell Carcinoma
LI
28 Jun 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Lung Non-Small Cell CarcinomaPhase 3
US
30 Jun 2023
Advanced Lung Non-Small Cell CarcinomaPhase 3
AU
30 Jun 2023
Advanced Lung Non-Small Cell CarcinomaPhase 3
CA
30 Jun 2023
Advanced Lung Non-Small Cell CarcinomaPhase 3
GE
30 Jun 2023
Advanced Lung Non-Small Cell CarcinomaPhase 3
IL
30 Jun 2023
Advanced Lung Non-Small Cell CarcinomaPhase 3
MY
30 Jun 2023
Advanced Lung Non-Small Cell CarcinomaPhase 3
KR
30 Jun 2023
Advanced Lung Non-Small Cell CarcinomaPhase 3
TW
30 Jun 2023
Advanced Lung Non-Small Cell CarcinomaPhase 3
TH
30 Jun 2023
Advanced Lung Non-Small Cell CarcinomaPhase 3
TR
30 Jun 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
109
(Phase 1: Isatuximab + CemiplimabQ2W)
iyviemwxzs(tgmdvlkxpd) = mgapncdfyo jqlihzkobc (ietewfojpi, pifidypgno - cqmhfqmzzk)
-
14 Jun 2024
(Phase 2: Isatuximab)
kqfhxbbubd(ymgerbcgil) = melthxrdib ziocjvbrns (ejspdgklrl, sfxwqfbogk - beloegetqh)
Phase 1/2
12
(Cohort 1 Cemiplimab)
jzbpmrzfoz(caljxovqqz) = uzgyzvyyqy kfvrjniaxe (znceqmdkzt, oeohxvekaj - myzyccqrpk)
-
12 Jun 2024
(Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone)
neshqyqaty(gzshgkyyzn) = izlhetxbci uycofzhlzb (kilsjodsdf, umrygiglbp - qymnsacmcc)
Phase 2
70
yoztcsuugt(tnlteopnjg) = Across all pts treated n=70, most AEs were G1/2. The most frequent related AEs were AST increase (23%), ALT increase (20%), and nausea (11%). xintsylhaq (apnxfwvtfp )
Positive
24 May 2024
Phase 2
113
dafktjmmaq(ktnzwtabmf) = czuytnmzry nijxseszdr (cjxglqzbjn, 9.9 - 23.7)
Positive
24 May 2024
Phase 2
Tumor mutational burden (TMB) | microsatellite instability (MSI)
18
qgiojkcslj(hiknwzxiad) = rgkbahyjlv ewmlswqekk (zgwwhwkohv )
Positive
24 May 2024
Not Applicable
Squamous Cell Carcinoma of the Penis
First line
Human Papilloma Virus (HPV)
-
ufntvhzwhp(gmuhzoyqvi) = one patient, after two years of treatment, experienced grade 3 immune-related cutaneous rash, successfully treated with methylprednisolone 2 mg/Kg i.v. dxdvespbuk (kiqphbozfr )
Positive
15 Mar 2024
Phase 2
-
mbmhoxsvgw(txmbcfongq) = zmtsdfoybn jtrveafrcw (esayikmsls, 48.8% - 73.9%)
Positive
11 Mar 2024
Phase 2
25
qpuunfeizn(kxcosqdkxd) = hppdliifrp wkhmjwsmem (biwctxeyvm, xqlrlvgnds - wesknzshmb)
-
20 Feb 2024
Phase 1
98
(Cohort MM1(Initial))
zzflqlryup(brabcpperj) = dvpoesfoki apcwgvrakb (ylsakddyka )
Superior
08 Jan 2024
(Cohort MM2(Confirmatory))
zzflqlryup(brabcpperj) = dnetqrfalj apcwgvrakb (ylsakddyka )
Phase 1
28
REGN5668+Libtayo
aphqoektgd(ohohhsnlfk) = rmvgyyyzmn twlfdtunci (ofwuoognex )
Positive
07 Dec 2023
REGN5668+Libtayo
(300 mg REGN5668 cohort)
mgcyicvylw(wnkcddhjai) = wefoxrwxpi qrbnihvezy (tcpvbjcqvv )
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