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丁丹（分析师）邮箱：电话：0755-23976735证书编号：S0880514030001甘坛焕（分析师）电话：021-38675855证书编号：S0880523080007唐玉青（研究助理）电话：021-38031031证书编号：S088012307013322023 年ESMO 重点创新药进展跟踪 0102ESMO(ESMO congress)2023 ESMO 202310 20-242023 ESMOLate-breaking abstracts,LBAOral,O Mini Oral,MO Poster,PESMO 1 PD-1IO 2 TIGHT KRAS G12C3ADCWUFUyRsPoNmNoQtQsPqPrQbRdNaQnPmMmOnOeRnMrReRnMxO7NrQpOxNpPpMNZpMrQ32023 年ESMO 重点创新药进展跟踪 2023 ESMOLBAHRS-4642 KRAS G12DA first-in-human phase 1 study of a novel KRAS G12D inhibitor HRS-4642 in patients w ith advanced solid tumors harboring KRAS G12D mutationKRAS G12D HRS-4642 KRAS G12D 1LBA33PD-1Neoadjuvant short-course radiotherapy followed by camrelizumab plus chemotherapy versus long-course chemoradiotherapy followed by chemotherapy in locally advanced rectal cancer:arandomized phase III trial(UNION)III UNIONLBA25+PD-1/+Camrelizumab plus famitinib versus camrelizumab alone and investigators choice of chemotherapy in w omen w ith recurrent or metastatic cervical cancer LBA44+PD-1/VEGFR-2+Perioperative camrelizumab(C)combined w ith rivoceranib(R)and chemotherapy(chemo)versus chemo for locally advanced resectable gastric or gastroesophageal junction(G/GEJ)adenocarcinoma:the first interim analysis of a randomized,phase 3 trial(DRAGON IV)G/GEJ3 DRAGON IV1512MONeoadjuvant Camrelizumab and Apatinib in Patients w ith Resectable Non-Small-Cell Lung Cancer:One-Year Update From a Phase 2 Trial2 11296P2023 ESMO42023 年ESMO 重点创新药进展跟踪 2023 ESMOSHR-A1811 HER2 ADCThe HER2-targeting ADC SHR-A1811 in HER2-expressing/mutated advanced non-breast solid tumors(STs):results from the global phase 1 study656MOPhase 1 trial of SHR-A1811 in HER2-expressing advanced gastric cancer(GC)or gastroesophageal junction adenocarcinoma(GEJ)and colorectal cancer(CRC)684PSHR-A2009 HER3 ADCPhase 1 study of SHR-A2009,a HER3-targeted ADC,in advanced solid tumors658MOSHR-1701 PD-L1/TGF-RIIA phase 1b/2 study of SHR-1701(a bifunctional anti-PD-L1/TGF-bevacizumab(BEV)in patients w ith advanced solid tumors1026MOSHR-1701 in combination w ith BP102 and XELOX as first-line(1L)treatment for patients(pts)w ith unresectable metastatic colorectal cancer(mCRC):data from a phase 2/3 study611P2023 ESMO52023 年ESMO 重点创新药进展跟踪 2023 ESMOPD-1Tislelizumab(TIS)Plus Chemotherapy(Chemo)vs Placebo(PBO)Plus Chemo as First-Line(1L)Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma(GC/GEJC):Final Analysis Results of the RATIONALE-305 Study LBA80Pathological Response to Neoadjuvant Tislelizumab(TIS)Plus Platinum-Doublet(PtDb)Chemotherapy(CT)in Resectable Stage II-IIIA NSCLC Patients(pts)in the Phase 3(Ph3)RATIONALE-315 Trial LBA58+PD-1/TIGHT/VEGFRAdvanTIG-206:Phase II randomized open-label study of ociperlimab(OCI)+tislelizumab(TIS)+BAT1706(bevacizumab biosimilar)versus TIS+BAT1706 in patients(pts)w ith advanced hepatocellular carcinoma(HCC)945MO+PD-1/TIGHTAdvanTIG-203:Phase II randomized,multicenter study of ociperlimab(OCI)+tislelizumab(TIS)in patients(pts)w ith unresectable,locally advanced,recurrent/metastatic esophageal squamous cell carcinoma(ESCC)and programmed cell death-ligand 1(PD-L1)positivity 1020MOPD-1/TIGHTAdvanTIG-202:Phase II randomized,multicenter,open-label study of tislelizumab(TIS)w ith or w ithout ociperlimab(OCI)in patients(pts)w ith previously treated recurrent/metastatic(R/M)cervical cancer(CC)744MO2023 ESMO62023 年ESMO 重点创新药进展跟踪 2023 ESMODP303c HER2 ADC ADCA multicenter,open-label,dose escalation and expansion study of DP303c in patients w ith HER2-postive pre-treated advanced solid tumors.385MOSYHA1813 VEGFR/CSF-1RA phase I dose-expansion cohort of SYHA1813,a vascular endothelial grow th factor receptor(VEGFR)1-3/colony-stimulating factor 1 receptor(CSF1R)inhibitor,in patients(pts)with recurrent meningioma.506MO2023 ESMOHS-20089 B7H4 ADC ADCFirst-in-human/phase I trial of HS-20089,a B7-H4 ADC,in patients w ith advanced solid tumors.381MOEGFREGFRAumolertinib plus apatinib versus aumolertinib as first-line treatment in patients w ith EGFR mutation positivelocally advanced or metastati non-small cell lung cancer(NSCLC):a randomized multicenter study LBA6972023 年ESMO 重点创新药进展跟踪 2023 ESMOAnlotinib plus chemotherapy as first-line therapy for gastrointestinal tumor patients w ith unresectable liver metastasis:preliminary results from a multi-cohort,multi-center phase II trial(ALTER-G-001)1628PPhase 2 study of anlotinib combined w ith taxanes and lobaplatin in the neoadjuvant treatment of triple-negative breast cancer:efficacy,safety and biomarker analysis from the neoALTAL trial246P+PD-L1/+Update results of anlotinib combined w ith TQB2450(PD-L1 blockade)as first-line treatment for advanced esophageal squamous cell carcinoma(ESCC):a single-arm,multicenter,open-label phase clinical trial1531P+PD-1/+Penpulimab+anlotinib plus chemo-less therapy in first-line treatment for persistent,recurrent,or metastatic cervical cancer:a single-arm,phase study(ALTN-AK105-II-06)763P2023 ESMO82023 年ESMO 重点创新药进展跟踪 2023 ESMO+()PD-1/+Penpulimab+anlotinib plus chemo-less therapy in first-line treatment for persistent,recurrent,or metastatic cervical cancer:a single-arm,phase study(ALTN-AK105-II-06)763PPD-1/VEGFRHARMONi:Randomized,double-blind,multi-center,phase III clinical study of ivonescimab or placebo combined w ith pemetrexed and carboplatin in patients w ith EGFR-mutant locally advanced or metastatic non-squamous NSCLC w ho have progression following EGFR-TKI treatment1504TiPPD-1/CTLA-4The efficacy and safety of cadonilimab combined w ith lenvatinib for first-line treatment of advanced hepatocellular carcinoma:A phase Ib/II clinical trial 947P2023 ESMOD-1553 KRAS G12CSafety and efficacy of D-1553 in combination w ith cetuximab in KRAS G12C mutated colorectal cancer(CRC):a phase II study 550OD-1553 in patients w ith KRAS G12C mutated advanced pancreatic cancer(PCa)1622P92023 年ESMO 重点创新药进展跟踪 FCN-159 MEK1/2A phase II study to explore the efficacy and safety of FCN-159 in recurrent or progressive pediatric low-grade glioma(pLGG)w ith MAPK pathw ay-activated499OHLX42 EGFR ADCTKIPreclinical evaluation of HLX42,a novel EGFR-targeting ADC,for cetuximab or TKI resistant cancer683PHLX43 PD-L1 ADCPreclinical activity of HLX43,a PD-L1-targeting ADC,in multiple PD-1/PD-L1 refractory/resistant models 693P2023 ESMOSKB264 TROP2 ADCSKB264(MK-2870)in previously treated hormone receptor-positive(HR+)/HER2-negative metastatic breast cancer(mBC):results from a phase I/II,single-arm,basket trialSKB264 HR+/HER2-I/II 380MO2023 ESMO102023 年ESMO 重点创新药进展跟踪 2023 ESMOPD-1EXTENTORCH:a randomized,phase III trial of toripalimab versus placebo,in combination w ith chemotherapy as a first-line therapy for patients w ith extensive stage small cell lung cancer(ES-SCLC)LBA93RENOTORCH:Toripalimab Combined w ith Axtinib versus Sunitinb in First-line Treatment of Advanced Renal-Cell Carcinoma(RCC):A randomized,Open-label,Phase 3 Study1882OA single-arm,multicenter clinical study of radiotherapy combined w ith toripalimab in stage I/II extranodalNK/T cell lymphoma 826O2023 ESMO+JAB-3312KRAS G12C/SHP2Glecirasib(KRAS G12C inhibitor)in combination w ith JAB-3312(SHP2 inhibitor)in patients w ith KRAS p.G12C mutated solid tumorsKRAS G12C JAB-3312 SHP2 KRAS G12C653O112023 年ESMO 重点创新药进展跟踪 2023 ESMOVEGFRUpdated results from the multicenter phase 2 study of fruquintinib plus mFOLFOX6/FOLFIRI as first-line therapy in advanced metastatic colorectal cancer(mCRC)612PA phase II study to evaluate the efficacy and safety of fruquintinib combined w ith tislelizumab and Hepatic artery infusion chemotherapy(HAIC)for advanced colorectal cancer liver metastases(CRLM)637PStereotactic ablative radiotherapy combined w ith fruquintinib and tislelizumab in metastatic colorectal cancer:Preliminary findings from a single-arm,prospective phase l trial(RIFLE)638PFirst report of the safety/tolerability and preliminary antitumor activity of fruquintinib plus capecitabine versus capecitabine as maintenance treatment for metastatic colorectal cancer:anopen_label randomized phase lb/lI study 639P2023 ESMO122023 年ESMO 重点创新药进展跟踪 2023 ESMOVEGFRFruquintinib combined w ith sintilimab and chemotherapy as the first line treatment in advanced naive EGFR-and ALK-negative non squamous non-small cell lung cancer(nsg-NSCLC):Updated results of a phase II trial 1494PFruquintinib Plus Sintilimab In Patients(Pts)With Either Treatmentnaive Or Previously Treated Advanced Gastric Or Gastroesophageal Junction(GEJ)Adenocarcinoma:Results From A Multicenter,SingleArm Phase 2 Study 1519PMET24-month follow up of durvalumab and savolitinib combination in MET driven clear cell and non-clear cell renal cancer 1888PFGFR1/CSF-1R/VEGFRPamiparib combined w ith Surufatinib as a neoadjuvant therapy for advanced ovarian cancer patients in the entire population:preliminary results of a prospective exploratory,single-arm phase II clinical study.762P2023 ESMO132023 年ESMO 重点创新药进展跟踪 2023 ESMOPD-L1Phase Ib/II trial of envafolimab,a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody,plus lenvatinib in patients w ith selected advanced solid tumors 1049PEnvafolimab plus chemoradiotherapy for locally advanced nasopharyngeal carcinoma(NPC),a prospective,single-armed phase II trial 920P+PD-L1+VEGFCombination therapy of envafolimab and suvemcitug in patients w ith hepatocellular carcinoma(HCC):Results from a phase II clinical trial 959PCombination therapy of envafolimab,suvemcitug,and FOLFIRI in patients w ith metastatic microsatellite stable(MSS)or mismatch-repair proficient(pMMR)colorectal cancer:Results from a phase II clinical trial636PNSCLCCombination therapy of envafolimab and suvemcitug w ith chemotherapy in patients w ith non-small cell lung cancer(NSCLC):Results from a phase II clinical trial 1467P2023 ESMO142023 年ESMO 重点创新药进展跟踪 2023 ESMOCDK4/6Antitumor activity and safety profile of trilaciclib in Chinese patients w ith extensive-stage small cell lung cancer(ES-SCLC)receiving chemotherapy(TRACES):Updated results from TRACES 1998PSupportive measures to control myelosuppression and costs for patients w ith SCLC w ith lurbinectedin,CAV or topotecan w ith or w ithout trilaciclib:A review on the basis of clinical trials 2024PPhase II trial of endostar in combination w ith concurrent chemoradiotherapy in patients w ith locally advanced squamous cell carcinoma of esophagus 1545PSIM0235 TNFR-2/CTCLSIM1811-03(SIM0235),an anti-tumor necrosis factor receptor-2(TNFR2)monoclonal antibody,in patients w ith advanced solid tumor and/or cutaneous T cell lymphomas(CTCL):Preliminary results from an on-going first-in-human phase I trial in China696PSIM0272 PRMT5A phase I study of safety,pharmacokinetics,and pharmacodynamics of SCR-6920,a protein arginine methyltransferase 5(PRMT5)inhibitor,in patients w ith advanced malignant tumors 675P2023 ESMO152023 年ESMO 重点创新药进展跟踪 2023 ESMOKN046 PD-1/CTLA-4Preliminary efficacy and safety of KN046(a bispecific anti-PD-L1/CTLA-4)in patients w ith metastatic non-small cell lung cancer w ho previously treated w ith immune checkpoint inhibitor(s)1459PUpdated results of the efficacy and safety of KN046(a bispecific anti-PD-L1/CTLA-4)in patients w ith metastatic non-small cell lung cancer(NSCLC)w ho failed prior EGFR-TKI(s)1330PThe preliminary data from a single-arm,open-label,multicenter phase II clinical trial:KN046 combined w ith axitinib as first-line(1L)treatment for NSCLC 1449PKN046 in patients w ith thymic carcinoma:A prospective,single-arm,multi-centre,phase II study2186PKN026 HER2/HER2Tw o-year follow-up data on the efficacy and safety of KN026,a HER2-targeted bispecific antibody combined w ith docetaxel as first-line treatment for HER2-positive recurrent/metastatic breast cancer418PKN026 in combination w ith docetaxel as neoadjuvant treatment for HER2+early or locally advanced breast cancer(BC):A single-arm,multicenter,phase II study247P2023 ESMO162023 年ESMO 重点创新药进展跟踪 2023 ESMOAPG-1252 Bcl-2/Bcl-xlUpdated study results of pelcitoclax(APG-1252)combined w ith osimertinib in patients(pts)w ith EGFR-mutant non-small cell lung cancer(NSCLC)1317MOBcr-Abl T315I/FGFR1/c-Kit/Flt3/PDGFR Antitumor activity of olverembatinib(HQP1351)in patients(pts)w ith TKI-resistant succinate dehydrogenase-(SDH-)deficient gastrointestinal stromal tumor(GIST)1973P2023 ESMO9MW2821 Nectin-4 ADCPreliminary results from a phase I/lI study of 9MW2821,an antibody drug conjugate targeting Nectin-4,in patients w ith advanced solid tumors.659MO8MW0511 G-CSFMW05,a novel,long-acting recombinant human serum albumin/human granulocyte-colony stimulating factor(I)fusion protein for the management of chemotherapy-induced neutropenia:Results of a phase III trial 2075P172023 年ESMO 重点创新药进展跟踪 2023 ESMOALKEfficacy and safety of ensartinib in ALK-positive non-small cell lung cancer patients w ith brain metastases:A multicenter,open-label,single-arm,phase II study1370P2023 ESMODB-1305 TROP2 ADCDB-1305(a Trop-2 targeted antibody-drug-conjugate(ADC)in patients(pts)with advanced solid tumors:Preliminary clinical results from the phase(Ph)1/2a study 689PPD-L1GEMSTONE-303:prespecified progression-free survival(PFS)and overall survival(OS)final analyses of a phase 3 study of sugemalimab plus chemotherapy vs placebo plus chemotherapy in treatment-na ve advanced gastric or gastroesophageal junction(G/GEJ)adenocarcinoma LBA79182023 年ESMO 重点创新药进展跟踪 2023 ESMOABSK-011 FGFR4First-in-human study of ABSK-011,a novel,highly selective fibroblast grow th factor receptor(FGFR)4 inhibitor for treating advanced hepatocellular carcinoma(HCC)w ith FGF19 overexpression 1012PABSK-043 PD-L1First-in-human dose-escalating study of ABSK043,a novel and oral small-molecule inhibitor of PD-L1,in patients w ith advanced solid tumors 700PBL-B01D1 EGFR/HER3 ADCBL-B01D1,a first-in-class EGFR x HER3 bispecific antibody-drug conjugate,in patients w ith Non-Smal Cell Lung Cancer.Updated results from first-in-human phase 1 study1316MOBL-M07D1 HER2 ADCBL-M07D1,a HER2 antibody-drug conjugate in subjects w ith locally advanced or metastatic HER2 expressing breast cancer and other solid tumors685P2023 ESMO192023 年ESMO 重点创新药进展跟踪 2023 ESMOIN10018 FAKIN10018 in combination w ith pegylated liposomal doxorubicin(PLD)in platinum-resistant ovarian cancer(PROC):A single-arm,phase Ib clinical trial 753PA phase Ib/II study of IN10018/FAKi in combination w ith pegylated liposomal doxorubicin(PLD)and Toripalimab in metastatic triple-negative breast cancer(TNBC):IN10018-010 398PQL1706 PD-1/CTLA-4Effcacy and safety of QL1706 plus paclitaxel and cisplatin/carboplatin+/-bevacizumab(Bev)as 1L treatment in recurrent or metastaltic cervical cancer(r/mCC):a single-arm,multicenter phase llstudy.743MO2023 ESMO202023 年ESMO 重点创新药进展跟踪 2023 ESMOCLDN18.2First Advanced G/GEJ Cancer w ith CLDN18.2 Positive-line TST001 plus Capecitabine and Oxaliplatin(CAPOX)for-Overall Survival data from Study TranStar102-Cohort C1524PPharmacokinetics,Pharmacodynamics and Exposure Response Analyses of Osemitamab in Patients w ith Locally Advanced or Metastatic Solid Tumors Osemitamab(
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