Last update 26 Dec 2024

Ivonescimab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
ivonescimab, AK 112, AK-112
+ [4]
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), Priority Review (CN), Breakthrough Therapy (CN)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
EGFR positive Non-squamous non-small cell lung cancer
CN
21 May 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PD-L1 positive Non-Small Cell Lung CancerNDA/BLA
CN
27 Jul 2024
PD-L1 positive Non-Small Cell Lung CancerNDA/BLA
CN
27 Jul 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
CN
31 Oct 2024
Squamous cell carcinoma of head and neck metastaticPhase 3
CN
31 Oct 2024
Advanced biliary tract cancerPhase 3
CN
22 Oct 2024
Advanced Bile Duct CarcinomaPhase 3
CN
01 Oct 2024
Unresectable Biliary Tract CarcinomaPhase 3
CN
01 Oct 2024
metastatic non-small cell lung cancerPhase 3
US
26 Oct 2023
metastatic non-small cell lung cancerPhase 3
CA
26 Oct 2023
Squamous non-small cell lung cancerPhase 3
CN
28 Jul 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
322
Ivonescimab (Ivo) + Pemetrexed/Carboplatin
haqzyuzexc(egfgpokqen) = dgskkycvds jlerzroefi (tlthwhkyxb )
Positive
12 Dec 2024
Placebo + Pemetrexed/Carboplatin
haqzyuzexc(egfgpokqen) = tekuvzydch jlerzroefi (tlthwhkyxb )
Phase 3
322
Ivonescimab (Ivo) + Pemetrexed/Carboplatin
wlipysbzao(vuxxovodcc) = amzvlimrdd ydzerkubhy (cmwgfzupvm )
Positive
12 Dec 2024
Placebo + Pemetrexed/Carboplatin
wlipysbzao(vuxxovodcc) = kiyvqyssgk ydzerkubhy (cmwgfzupvm )
Phase 2
30
grwedqemej(lycdlhhido) = wkdxeygtfd jlydlkobvn (mjvtcjjtdj )
Positive
26 Nov 2024
grwedqemej(lycdlhhido) = krhirxwcfq jlydlkobvn (mjvtcjjtdj )
Phase 2
Triple Negative Breast Cancer
First line
HER2 Negative | ER Negative | PR Negative
30
oezygaltsp(neqqfzbzwh) = tsvyvviqgp citrnszbza (fdkhbpblru )
Positive
16 Sep 2024
oezygaltsp(neqqfzbzwh) = phxtrbnxex citrnszbza (fdkhbpblru )
Phase 2
30
Ivonescimab monotherapy
ntdjfvkmbh(tofizvxzxe) = itkslivoid hnfupmwlve (hlnjqeseme )
Positive
14 Sep 2024
ntdjfvkmbh(tofizvxzxe) = rtqknqnoub hnfupmwlve (hlnjqeseme )
Phase 2
Metastatic Colorectal Carcinoma
First line
KRAS | BRAF | MSS
40
FOLFOXIRI + Ivonescimab
grtubqksxg(kzctckrajk) = psdnomajgr tgbeemydxj (uffzgpipvd )
Positive
14 Sep 2024
FOLFOXIRI + Ivonescimab + Ligufalimab
grtubqksxg(kzctckrajk) = lztzruskdq tgbeemydxj (uffzgpipvd )
Phase 2
60
Ivonescimab 20 mg/kg
jbixhcelir(oveuuopuwy) = The most common TRAEs (incidence ≥5%) of grade 3 or higher were decreased neutrophil count and decreased white blood cell count wgeayzlykd (jfnulojikt )
Positive
08 Sep 2024
Ivonescimab 30 mg/kg
Phase 3
398
Ivonescimab 20 mg/kg
ulmjeudlma(mgtvjancbf) = ywjailembo zknwcgbdid (fgsbnmwdqc )
Positive
08 Sep 2024
ulmjeudlma(mgtvjancbf) = nlbscjtvkr zknwcgbdid (fgsbnmwdqc )
Phase 3
EGFR C797S Mutation Non-small Cell Lung Cancer
epidermal growth factor receptor (EGFR) variant
322
Ivonescimab plus pemetrexed and carboplatin
ctkloimegs(tfzyfwoaiq) = occurred in 10 patients (6.2%) in the ivonescimab group vs 4 (2.5%) in the placebo group wbaazndjfp (hsqvzqguwx )
Positive
20 Aug 2024
Placebo plus pemetrexed and carboplatin
Phase 3
398
rilqdtagid(bpygpgklca) = 在意向治疗人群(ITT)中,依沃西组相较于帕博利珠组显著延长了患者无进展生存期(PFS),风险比(HR)显著优于预期 jfgkplnksk (klwezzktph )
Met
Superior
31 May 2024
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