Drug Type Bispecific antibody |
Synonyms ivonescimab, AK 112, AK-112 + [4] |
Target |
Mechanism PD-1 inhibitors(Programmed cell death protein 1 inhibitors), VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date CN (21 May 2024), |
RegulationFast Track (US), Priority Review (CN), Breakthrough Therapy (CN) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
EGFR positive Non-squamous non-small cell lung cancer | CN | 21 May 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
PD-L1 positive Non-Small Cell Lung Cancer | NDA/BLA | CN | 27 Jul 2024 | |
PD-L1 positive Non-Small Cell Lung Cancer | NDA/BLA | CN | 27 Jul 2024 | |
Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | CN | 31 Oct 2024 | |
Squamous cell carcinoma of head and neck metastatic | Phase 3 | CN | 31 Oct 2024 | |
Advanced biliary tract cancer | Phase 3 | CN | 22 Oct 2024 | |
Advanced Bile Duct Carcinoma | Phase 3 | CN | 01 Oct 2024 | |
Unresectable Biliary Tract Carcinoma | Phase 3 | CN | 01 Oct 2024 | |
metastatic non-small cell lung cancer | Phase 3 | US | 26 Oct 2023 | |
metastatic non-small cell lung cancer | Phase 3 | CA | 26 Oct 2023 | |
Squamous non-small cell lung cancer | Phase 3 | CN | 28 Jul 2023 |
Phase 3 | EGFR-mutated non-small Cell Lung Cancer EGFR Mutation | 322 | Ivonescimab (Ivo) + Pemetrexed/Carboplatin | haqzyuzexc(egfgpokqen) = dgskkycvds jlerzroefi (tlthwhkyxb ) View more | Positive | 12 Dec 2024 | |
Placebo + Pemetrexed/Carboplatin | haqzyuzexc(egfgpokqen) = tekuvzydch jlerzroefi (tlthwhkyxb ) View more | ||||||
Phase 3 | EGFR-mutated non-small Cell Lung Cancer EGFR mutation-positive | 322 | Ivonescimab (Ivo) + Pemetrexed/Carboplatin | wlipysbzao(vuxxovodcc) = amzvlimrdd ydzerkubhy (cmwgfzupvm ) | Positive | 12 Dec 2024 | |
Placebo + Pemetrexed/Carboplatin | wlipysbzao(vuxxovodcc) = kiyvqyssgk ydzerkubhy (cmwgfzupvm ) | ||||||
NCT05227664 (SABCS2024) Manual | Phase 2 | Triple Negative Breast Cancer First line | 30 | grwedqemej(lycdlhhido) = wkdxeygtfd jlydlkobvn (mjvtcjjtdj ) View more | Positive | 26 Nov 2024 | |
(PD-L1 CPS ≥10) | grwedqemej(lycdlhhido) = krhirxwcfq jlydlkobvn (mjvtcjjtdj ) View more | ||||||
NCT05227664 (ESMO2024) Manual | Phase 2 | 30 | oezygaltsp(neqqfzbzwh) = tsvyvviqgp citrnszbza (fdkhbpblru ) View more | Positive | 16 Sep 2024 | ||
oezygaltsp(neqqfzbzwh) = phxtrbnxex citrnszbza (fdkhbpblru ) View more | |||||||
NCT05229497 (ESMO2024) Manual | Phase 2 | 30 | Ivonescimab monotherapy | ntdjfvkmbh(tofizvxzxe) = itkslivoid hnfupmwlve (hlnjqeseme ) View more | Positive | 14 Sep 2024 | |
ntdjfvkmbh(tofizvxzxe) = rtqknqnoub hnfupmwlve (hlnjqeseme ) View more | |||||||
NCT05382442 (ESMO2024) Manual | Phase 2 | 40 | FOLFOXIRI + Ivonescimab | grtubqksxg(kzctckrajk) = psdnomajgr tgbeemydxj (uffzgpipvd ) View more | Positive | 14 Sep 2024 | |
grtubqksxg(kzctckrajk) = lztzruskdq tgbeemydxj (uffzgpipvd ) View more | |||||||
NCT05247684 (WCLC2024) Manual | 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 ) View more | Positive | 08 Sep 2024 | |
Ivonescimab 30 mg/kg | |||||||
Phase 3 | 398 | Ivonescimab 20 mg/kg | ulmjeudlma(mgtvjancbf) = ywjailembo zknwcgbdid (fgsbnmwdqc ) View more | Positive | 08 Sep 2024 | ||
Pembrolizumab 200 mg | ulmjeudlma(mgtvjancbf) = nlbscjtvkr zknwcgbdid (fgsbnmwdqc ) View more | ||||||
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 ) View more | 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 | |||