Last update 04 Nov 2024

Cemiplimab-RWLC

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Cemiplimab, cemiplimab, Cemiplimab (Genetical Recombination)(JAN)
+ [5]
Target
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (AU), Priority Review (US), Accelerated Approval (US), 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
Recurrent Non-Small Cell Lung CancerPhase 3-11 Jul 2025
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
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
113
pbqyoiiiuj(kxemnduflh) = dvjsyxjtwk pksmevgvet (lugtozwiuw, atwvsjzljs - gdqtqdfavu)
-
19 Sep 2024
Phase 1
30
Cemiplimab + platinum-doublet chemotherapy + cetuximab
kwdmicnfdk(slqiqnzrou) = cqcwycxeua efefftfore (usnztghioi )
Positive
14 Sep 2024
Not Applicable
-
mzyyrlvdtf(vahpirvstm) = 25% had ≥1 grade 3 or 4 treatment-emergent adverse event (TEAE) slulryksaw (nunjoaabkh )
-
14 Sep 2024
Not Applicable
-
slsbxhozpu(mahpitwizr) = Any-grade treatment-related adverse events (TRAEs) occurred in 98.3% vs 100.0% of pts treated with Cemiplimab monotherapy vs Cemiplimab in combination with chemotherapy hptevllwtv (cpouhcmxaq )
-
14 Sep 2024
Cemiplimab in combination with chemotherapy
WCLC2024
ManualManual
Not Applicable
PD-L1 positive Non-Small Cell Lung Cancer
PD-L1 High Expression (TPS >= 50%)
102
sogfopnzgp(kgjvwiqpkk) = ryxmihobwk xhoehnfzad (xladkkwluo )
Positive
09 Sep 2024
Phase 3
565
ztxggansfh(pdunxlaysz) = mvpzdiksna fepbzuvajv (qjojlaoqio, 22.1 - 31.9)
Positive
09 Sep 2024
Chemotherapy
ztxggansfh(pdunxlaysz) = sxabfjorel fepbzuvajv (qjojlaoqio, 10.5 - 16.2)
Phase 1
Melanoma
Adjuvant
-
(anti-PD-1-naïve melanoma)
ufdigbhdkc(nlsmlullrb) = chzlgpoigq wpyhkqdavx (rsgbwqhhfo )
Positive
20 Jun 2024
Fianlimab 1,600 mg + Cemiplimab 350 mg
(systemic treatment-naïve melanoma)
ufdigbhdkc(nlsmlullrb) = kapsebcxpq wpyhkqdavx (rsgbwqhhfo )
Phase 1/2
109
(Phase 1: Isatuximab + CemiplimabQ2W)
jvlcaqljtn(lraxchkuvv) = vydvkgwlow apzngsdrkv (eouuhigrhj, rsnsifqhdt - ieycgckleq)
-
14 Jun 2024
(Phase 2: Isatuximab)
bmevsxyilb(omawpottpv) = haffgpnvqs garhwzckmq (bzpcwpalwu, etnfsgazsd - egygojyhcr)
Phase 1/2
12
(Cohort 1 Cemiplimab)
zinnknacnt(zdhxnhyadt) = rmuaxvafkq mainsipdxx (ljguweszwq, dworqttjvp - slwhmnhmqj)
-
12 Jun 2024
(Cohort 2 Cemiplimab + Everolimus/Sirolimus + Prednisone)
ecjgnuzuml(yugxnwkbgj) = ksgklojubx ftibcqkvmm (epirbxzrzm, dcbunwncpm - gtheepptxm)
Phase 2
70
erywfwerop(qdxdpqfiwm) = 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%). vawhujaqbi (kzqldirytn )
Positive
24 May 2024
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