20230612_德邦证券_医药行业证券研究报告：重点摘要汇总及数据横向对比_64页.pdf

02023ASCO()2023 6 12|S0120521080001 chentl S0120522100005 1 ASCO ASCO American Society of Clinical Oncology 1964 ASCO 2023 ASCO ADC CAR-T PD-(L)1 EGFR HER2 ASCO TKI HER2+TIGIT IBI939 ociperlimab LAG-3 IBI110 LBL-007 BCL-2 BGB-11417 APG-2575 CLDN18.2 SYSA1801 CT041 ZL-1211 TST001 CDK4/6 BPI-16350 ADC BL-B01D1 SYSA1801 SKB-264 DB-1303 SHR-1701 SI-B001 SI-B003 AK112 ZXBYvMtOmPnMsMnOrMsNoP9PaObRoMqQtRoNiNmMtNlOpOnO9PrRzRvPmRrRNZpOwO2 013 13 2023 ASCO ASCO HER2 HER2 IIb 2b HERIZON-BTC-01 Zanidatamab HER2 HER2 HER2 Ib/II Zanidatamab HER2 HER2 1b/2 BGB-11417 Bcl-2 B I 1 Bcl-2 BGB-11417 B ociperlimab TIGIT PD-1 IV/Ib AdvanTIG-105 1b ociperlimab+tislelizumab IV/GC/GEJC BGB-A445 OX40 PD1 I OX40 BGB-A445 BGB-A445 1 PD-1 III Tislelizumab sorafenib HCC RATIONALE-301/PD-1 HCC tislelizumab OS BTK/B I zanubrutinib lenalidomide/R/R B DLBCL 1 BTK/II Zanubrutinib obinutuzumab obinutuzumab/ROSEWOOD BTK III MAHOGANY 3 zanubrutinib CD20 vs lenalidomide rituximab BTK/MAIC zanubrutinib ibrutinib/R/R MZL MAIC BTK MAIC zanubrutinib rituximab MZL MAIC BTK BTKi MCL 2023 ASCO ociperlimab BGB-A445 BGB-11417 HER2 BTK PD-1 OX40 TIGIT Bcl-2 4 HER2 Oral ASCO 2b HERIZON-BTC-01 Zanidatamab HER2 HER2 HER2 2 IIb NCT04466891 20mg/kg 2 HER2 BTC GBC/ICC/ECC ORR CR PR SD PD mDOR 1 N=80 41%1%32%22%24%12.9m N=87 TRAEs 72%3 TRAEs 18%4 Aes HER2 HER2 BTC HER2 HER2 HER2 3 2 Pierre Fabre HER2 HER2 3/Daiichi SankyoHER2 ADC HER2 3/HER2 HER2 3/ORR AEs HER2 87 54%66%1(1-7)41%TRAEs 72%3 TRAEs 18%4 Aes DaiichiSankyoHER2 22 HER2 BTC 236.4%TEAE81.3%TEAE 85 BGB-11417 B ASCO 1 Bcl-2 BGB-11417 B BGB-11417 Bcl-2 1 B MTD 2 RP2D 80 160 320 640 mg 21 DLT 61 31-84 2 1-7 6.6 0.2-13.0 BGB-11417 640 mg R/R CLL/SLL B BGB-11417 Bcl-2 B 2 2 Bcl-2 B APG2575 Bcl-2 B 2 2 ORR AEsBGB-11417R/R CLL/SLL12 75%TEAE 92.6%3 TEAE 53.7%TEAE 14.8%640mg MTDAPG2575 R/R CLL/SLL41 68%3 AEs 62.2%NHL CLL/SLLR/R CLL/SLLRP2DN 27 12 9ORR/18.5%75.0%320mg/dN=54 TEAE 92.6%3 TEAE 53.7%TEAE 14.8%640mg MTD6 OCI+TIS GC/GEJC ASCO AdvanTIG-105 1b ociperlimab+tislelizumab IV GC/GEJC AdvanTIG-105 OCI TIGITmAb TIS PD-1 mAb 1/1b/IV GC/GEJC 1 OCI+TIS+Q3W OCI+TIS Q3W 2 RP2D OCI+TIS+5-Q3W OCI 900 mg+TIS 200 mg+IV GC/GEJC ORR DCR mDOR mPFSN=59 50.8%84.7%4.6m 8.2m TEAE 100%3 TEAE 71.7%TRAE 46.7%8.3%3.3%TIGIT 1 1 domvanalimab TIGIT 3/tiragolumab TIGIT 2 27 028 5 2023 ASCO ASCO/III mNSCLC TTFields SOC 3 LUNAR PARP III/PRIME PARP OC 1st-L MT KIT PDGFR II GIST 4 2 ZL-1211 Claudin 18.2 I/II ZL-1211 Claudin 18.2 mAb I/II first-in-class 2023 ASCO PARP KIT P DGFR ZL-1211 Claudin 18.2 9 NSCLC ASCO(TTFields;150kHz)(SOC)(mNSCLC)III LUNAR(EF-24 Novocure III LUNAR Novocure LUNAR LUNAR III TTFields ICI ICI NSCLC TTFields ICI ICI 64 22-86 65%96%ECOG 0-1(30%)(30%)(30%)(9%)89%31%ICI 58%2%ICI TTFields+mOS 13.2 mOS 9.9 TTFields+ICI mOS 18.5 ICI mOS 10.8 TTFields+mOS 11.1 mOS 8.7 TTFields LUNAR 2023(FDA)(PMA)LUNAR Novocure FDA NMPA(MAA)10 ZL-1211 Claundin 18.2 FIC ASCO THE LANCET,ZL-1211 Claudin 18.2 mAb I/II first-in-class ZL-1121 Claudin18.2 G1,Fc S239D I332E:I/II NCT05065710 3+3 ZL-1211 5 1 40mg/kg I II 19 78.9%2 11 6 9 6 SDN=19 DLT;TRAEs 57.9%31.6%15.8%TRAE 15%15.8%15.8%3 3 TRAE ZL-1211 zolbetuximabGanymedPharmaceuticalsCLDN18.2 3 3 TST001 CLDN18.2 2 1 ASKB589 AskGene CLDN18.2 1/2 1/2 ZL-1211 CLDN18.2 1/2 1/2 11 0312 56 8 ASCO 2023 ASCO 5 3 PD-L1/TGF-RII SHR-1701 EZH2 SHR2554 SHR-1701+SHR2554 PD-L1/TGF-EZH2 I/II PD-1 III HER2 PD-1 VEGF II+PD-1 II+CDK4/6 HER2 II CDK4/6HER2HR HER2 II CDK4/6 HR HER2 N/A+CDK4/6 HER2 HR HER2 I/II+CDK4/6 HER2 HER2 II+CDK4/6 HER2HER2 II SHR-1701 PD-L1/TGF-Ib/III PD-1 II+PD-1 VEGFR-2 II N/A+PD-1 II PD-L1 II PD-1 IV13 SHR-1701 SHR2554 cHL Oral ASCO 2022 PD-L1/TGF-SHR-1701 EZH2 SHR2554 I zeste 2(EZH2)I SHR2554 300 350mg bid SHR-1701 30mg/kg q3w RP2D SHR2554 SHR-1701 cHL PD1/PD-L1 ORR CRN=26 57.7%cHL N=16 100%7.1%N=32TRAEs 40.6%SHR-1701 SHR2554 cHL SHR-1701 PD-L1/TGF-NSCLCIII III bintrafuspalfaGSK;MerckKGaAPD-L1/TGF-III III14 2L Oral ASCO 555P TQB2450 injection combined with anlotinib hydrochloride capsule in the treatment of advanced,recurrent or metastatic endometrial cancer X.Wu et al.CAP 04 EC PD-1 EC 200 mg 2 1 250 mg 1 4 1 ORR DCR mPFS mOSN=36 44.4%91.7%6.4 21.0N=3619 52.8%3 TRAEs ORR DCR mPFS AEs+2L44.4%91.7%6.4 TRAEs 52.8%+PDL12L33.3%76.7%6.6 3 TEAEs 20.63%15 SHR-1701 ASCO SHR-1701 BP102 Ib/III SHR-1701 PD-L1 TGF-3 SHR-1701(30 mg/kg)(AUC 5)BP102(15 mg/kg)ORR DCR CR PR SD PD6m PFSIb N=31 77.4%93.5%12.9%64.5%15.1%6.5%93.5%N=31 TRAEs 80.6%8 25.8%SHR-1701 BP102 III SHR-1701Dong-A Pharma;PDL1/TGFBR2 III III bintrafuspalfaGSK;MerckKGaAPDL1/TGFBR2 III ORR AEsSHR-1701+PD-L1/TGF-R21L R/M 77.4%TRAEs 80.6%AK104+PD-1/CTLA-41L R/M 79.3%TRAEs 60.0%16 0417 3 ASCO PD-1/CTLA-4 G/GEJC Ib/II G/GEJC Ib/II 2 PD-1/CTLA-4 G/GEJC I/II CD47 AK117+G/GEJC PD-1/VEGFEGFR/ALK II PD-1/VEGF AK112/SMT112 EGFR/ALK II 2023 ASCO PD-1/CTLA-4/G/GEJC PD-1/VEGF AK112/SMT112 EGFR/ALK NSCLC CD47 AK117 G/GEJC 18 ASCO PD-1/VEGF AK112/SMT112 EGFR/ALK II Ivonescimab PD-1/VEGF II 3 10 20 mg/kg ivonescimab SCC SCC/NSCLC ORR DCR 9-mo PFS 9-mo OS mDOR N=63 75%95%67%93%15.4m N=72 55%100%61%81%N=135 TRAEs 28.1%TRAEs 6.7%Ivonescimab AGA/NSCLC SCC SCC PD-1/VEGF III III PM8002 PDL1/VEGF-A II II AP505 PDL1/VEGF I I ORR 1L NSCLC 75%55%1L NSCLC 62.6%48%19 0520 26 ASCO 2023 ASCO PD1 HBM4003 CTLA4 HCC Ib HCC II II II LBL-007 I II/I/II/Ib/II I/II 2023 ASCO PD-1 BTLA tifcemalimab 26 PD1 NSCLC Ib/II II III EGFR/ALK NSCLC III III II/III III II II II IV Ib I/II BTLAtifcemalimab21 Tifcemalimab ES-SCLC ASCO Tifcemalimab(ES-SCLC)I/II Tifcemalimab JS004 TAB004 IgG4(S228P)BTLA HVEM 200mg Tifcemalimab 240mg 2 ES-SCLC ORR DCRN=38 26.3%57.9%N=43TRAEs 74.4%3 TRAEs 27.9%TRAEs 7%irAEs 34.9%3 irAEs 4.7%Tifcemalimab ES-SCLC icatolimab BTLA I/II I/II HFB200603 HiFiBiO BTLA I 22 0623 5 2023 ASCO ADC BL-B01D1 EGFR/HER3 I BL-B01D1 EGFRxHER3 ADC 1 SI-B001 EGFR/HER3 EGFR/ALK II SI-B001 EGFR/ALK 2 SI-B001 EGFR/HER3 II 2 SI-B001 EGFR HER3/HNSCC GNC-038CD19/CD3/PD-L1/4-1BBR/R I GNC-038/1 SI-B003 PD-1/CTLA-4 I SI-B003 PD-1/CTLA-4 1 2023 ASCO ADC BL-B01D1 SI-B001 GNC-038 SI-B003 EGFR/HER3 CD19/CD3/PD-L1/4-1BB PD-1/CTLA-4 ASCO 24 BL-B01D1 Oral ASCO BL-B01D1 EGFRxHER3 ADC 1 BL-B01D1 ADC EGFRxHER3 TOP-I D-ESC,i3+3 BL-B01D1 0.27 1.5 3.0 mg/kg QW 2.5 3.0 3.5mg/kg D1D8 Q3W 4.5 5.0 6.0 mg/kg D1 Q3W PR SD PD ORR DCRNSCLC(EGFRmut)34 4 6 10 3 61.8%91.2%NSCLC(EGFRwt)42 2 10 23 2 40.5%95.2%(SCLC)7 2 0 5 1 14.3%85.7%(NPC)24 3 8 13/45.8%100%HNSCC 13 3 1 9 3 7.7%76.9%3.0mg/kg QW 3.5mg/kg D1D8 Q3W DLT BL-B01D1/EGFRm NSCLC 25 SI-B001 NSCLC EGFR/ALK ASCO SI-B001 EGFR/ALK 2 SI-B001 EGFR HER3 1 16+9mg/kg 2 3 1 8 14mg/kg 3 21+12mg/kg 55 EGFR/ALK NSCLC(PBC)PD-1/L1 ORR DCR N=48 31.3%77.1%1 N=22 45.5%68.2%1 AGA N=18 50.0%72.2%(TRAEs)(17%)(15%)(12%)SI-B001 NSCLC EGFR/ALK AGA 26 SI-B001/HNSCC ASCO 2 SI-B001 EGFR HER3/HNSCC SI-B001 EGFR HER3 1 S209 16mg/kg IV QW 2 S206 A 12mg/kg IV QW SI-B001 80mg/m2IV QW B 12mg/kg IV QW SI-B001 35mg/m2IV Q4W 1 S209 11 4 HNSCC PD-1/L1 2 S206 10/19/cPR PR SD PD ORR DCRS209 N=9 2 0 5 2 22.2%77.8%S206 A N=14 4 5 4 1 64.3%92.9%S206 B N=8 0 1 4 3 12.5%62.5%S209 3(TRAEs)(9%)S206 3+TRAEs(16%)(8%)(8%)SI-B001 SI-B001 HNSCC ORR DCR 27 SI-B003 PD-1/L1 ASCO SI-B003 PD-1/CTLA-4 1 SI-B003 PD-1/CTLA-4 PD-1 CTLA-4 T SI-B003 IV Q2W 1 1a mTPI-2 0.1 3 5 10mg/kg 2 1b 5 10mg/kg Q2W 7.5mg/kg Q3W 55.5 mPFS ORR DCRN=56 3.7m 16.1%50.0%TRAEs(35%)AST(28%)ALT(28%)TRAEs AST(3%)SI-B003 PD-1/L1 SI-B003 PD-1/CTLA-4 I/II I PD-1/CTLA-4 KN046 PD-L1/CTLA-4 NSCLC 3 3 28 0729 ASCO EGFR exon20EGFR20 EGFR20 JAK1 T T JACKPOT8 EGFR exon20EGFR20 I/II EGFR20 EGFR exon20EGFR TKI EGFR I EGFR TKI EGFR 2023 ASCO EGFR 20 EGFR exon20ins NSCLC JAK1 ASCO30 Oral ASCO EGFR20 Sunvozertinib(DZD9008)EGFR 20(exon20ins)EGFR II 300 mg sunvozertinib EGFR 20ins NSCLC ORRN=97 60.8%48.5%N=104 TEAE 1 2 sunvozertinib EGFR 20ins EGFR exon 20 NSCLC EGFR exon 20 NSCLC EGFR exon 20 NSCLC 2 EGFR exon 20 NSCLC YK-029A EGFR exon 20 NSCLC 3 3 ORR AEsEGFRex20ins NSCLC97 32%5895.9%95.9%32%260.8%48.5%TEAE 1 2 EGFRex20ins NSCLC20 10 50.0%51 32 7770%3 NSCLC31 r/r PTCL Oral ASCO T JACKPOT8/r/r PTCL Golidocitinib JAK1 150 mg golidocitinib 1 3/PTCL ORR CRN=80 43.8%25%N=87 TRAE 37.5%5.8%7.7%Golidocitinib r/r PTCL Novartis;IncyteJAK1 T AstraZeneca;JAK1 T II II T32 0833 3 ASCO HS-20093 B7-H3 I ARTEMIS-001 HS-20093 B7-H3-HS-10241 c-Met EGFR+NSCLC Ib HS-10241 EGFR NSCLC 1b HS-10382 BCR-ABL I I HS-10382(TERN-701)CML PK 2023 ASCO HS-20093 B7-H3 HS-10241 c-Met EGFR MET NSCLC HS-10382 BCR-ABL CML 34 HS-20093 ASCO HS-20093 B7-H3 I B7-H3 B7 HS-20093 B7-H3 I 1.0 16.0 mg/kg HS-20093 3+3 DCR PR N=40 85.0%35.0%SCLC N=9/77.8%N=53TEAEs 100%HS-20093 SCLC MGC018 MacroGenics B7-H3 ADC II/III HS-20093 B7-H3 ADC II II DS-7300Daiichi SankyoB7-H3 ADC II II MHB088C B7-H3 ADC I/II I B7-H3 ADC 35 0936 2 2023 ASCO RET ALK ASCO SY-5007 RET;I SY-5007 RET RET I SY-3505 ALK;I/II ALK TKI SY-3505 ALK I/II 2023 ASCO SY-3505 ALK SY-5007 RET RET NSCLC RET 37 SY-5007 RET Alexander Drilon et al.Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer ASCO SY-5007 RET RET I RET 50-60%MTC RET TKIs(FDA RET SY-5007 RET RET 3+3 SY-5007 20mg 28 20 40 80 120 160 200mg 160 200mg II RET SY-5007 RET NSCLS RET MTC ORR TRAEs(3SY-5007 2L RET NSCLC 75%36.7%Pfizer;Eli Lilly 2L RET NSCLC 64%14%ORR DCRNSCLCN=2875%91.7%N=60TRAEs 91.7%3 TRAEs 36.7%Pfizer Eli Lilly RET RocheRET SY-5007 RET II IKL590586 RET I/II I/II RET38 SY-3505 ALK Lu,Shun et al.Lorlatinib for Previously Treated ALK-Positive Advanced NSCLC:Primary Efficacy and Safety From a Phase 2 Study in Peoples Republic of China.ASCO ALK TKI SY-3505 ALK I/II SY-3505 ALK TKI ALK TKI ALK I 25-800mg SY-3505 500/600mg II ALK TKI ALK NSCLC 600mg SY-3505 2 ALK TKIs ALK NSCLC ORR DCRN=82 34.2%74.4%N=92TRAEs 57.1%3 TRAEs 3.6%SY-3505 ALK ALK SY-3505 ALKII II Pfizer;ALK ORR TRAEs(3SY-3505 ALK NSCLC 34.2%3.6%Pfizer;ALK NSCLCALK 47.6%8.3%39 1040 4 2023 ASCO NSCLC ASCO APG-2449 FAK/ALK NSCLC I FAK/ALK APG-2449 FAK NSCLC ALK BCR-ABL GIST Ib/II HQP1351 TKI SDH-deficient GIST APG-2575 BCL-2 WM Ib/II Bcl-2 APG-2575 WM Ib/II APG-115 MDM2 II APG-115 IO II 2023 ASCO BCR-ABL Bcl-2 APG-2575 MDM2-p53 APG-115 FAK/ALK/ROS1 APG-244941 APG-2449 ALK NSCLC Soria,Jean-Charles et al.First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer(ASCEND-4):a randomised,open-label,phase 3 study ASCO FAK/ALK APG-2449 FAK NSCLC ALK APG-2449 FAK ALK/ROS1 TKI 900-1500 mg RP2D 1200 mg NSCLC 2 1 ALK/ROS1 TKI ALK NSCLC 2 TKI ALK ROS1 NSCLC 130 53 ORR DCR TKINSCLCN=31ROS1N=1770.6%88.2%ALK:N=14 78.4%100%ALKNSCLC ALK:N=27 25.2%PR TRAEs:90%,3 TRAEs:13.1%APG-2449 FAK ALK NSCLC Novartis;AstraZenecaALK conteltinib ALK;FAK;IGF-1R;PYK2 3 3 ORR mPFS TRAEsNovartis;AstraZeneca 55376 ALK 72.5%16.6mAPG-2449130 53 78.4%/TRAEs:90%,3 TRAEs:13.1%42 APG-2575 WM Castillo JJ et al.ASCO Bcl-2 APG-2575 WM Ib/II APG-2575 BCL-2 APG-2575 PDXWM1 APG-2575-2 APG-2575 400mg 1200mg A APG-2575 BTKi/B APG-2575+C APG-2575+/BTKi ORR MTTRA N=14 25%4.3mB N=24 90.9%1.9mC N=8 37.5%4.4m1200mg DLT;3 AEs 13%4.3%2.2%2.2%2.2%APG-2575 BTKi WM Roche;AbbVieBCL-2 2/FCN-338Eli Lilly;BCL-2 1/BGB11417 BCL-2 1 1 ORR MTTR TRAEsAPG-2575Roche;AbbVie 24 WM90.9%/3 AEs 45 67 67%100%1.9m 7 4 5 AE 2 3 43 1144 5 2023 ASCO ASCO PD-1 III IC-CCRT IC-CCRT III IBI110 LAG-3 Ib IBI110(LAG-3)HER2:Ib IBI110 LAG-3 Ib IBI110(LAG-3):Ib IBI351 KRAS G12C I IBI351(GFH925)KRASG12C I CT103A BCMA I/II B CAR-T(CT103A)/I/II FUMANBA-1 HQP1351 BCR-ABL1 KIT PDGFRAGIST I HQP1351 TKI SDH-deficient GIST IBI939 TIGIT IbIBI939(TIGIT)PD-L1 Ib 2023 ASCO IBI110 LAG-3 IBI939 TIGIT IBI351 KRASG12C 45 CONTINUUM ASCO PD-1 IC-CCRT IC-CCRT LANPC 3 CONTINUUM 425 III-IVA T3-4N0/T3N1 1:1 IC-CCRT n=210 IC-CCRT n=215 200mg 3 1 12 3 3 6)EFS/)3 3 EFS 86.1%76.0%HR 0.59 3 DMFS 90.3%82.8%HR 0.57 3 LRRFS 93.4%86.8%HR 0.52 3-4 AE 155 74.2%140 65.4%PD-1/PD-1 IC-CCRT III IC-CCRT 41%3 10%46 IBI939 NSCLC DOI:10.1200/JCO.2020.38.15_suppl.9503 Journal of Clinical Oncology ASCO IBI939(TIGIT)PD-L1 Ib IBI939 PD-NSCLC PFS Ib NCT04672369 IBI939 20 mg/kg 200 mg A 200 mg B NSCLC PD-mPFS A N=28 13.2m B:N=14 6.4mN=42TRAE 96.4%vs 78.6%,3 AEs:10.7%vs 28.6%TEAE IBI939 NSCLC MK-7684AMerck&Co.TIGIT;PD1 3 3 tiragolumab Roche TIGIT 3 3 TIGIT 3 3 ORR mPFS AEsIBI939 NSCLC NSCLC PD-/13.2mTRAE:96.4%,3AEs:10.7%tiragolumabRoche NSCLC PD-L1 ECOG 0-1EGFR ALK NSCLC31.3%5.4mTRAE:80.6%3 TRAE:14.9%47 1248 KL590586 RET Oral ASCO RET KL590586 RET I KL590586 A400/EP0031 RET SRI SRI mets 10 120 QD 6 RET 57 NSCLC 10 1 1 KL590586 RET ORR DCR N=69 64%91%1L NSCLC N=25 76%92%N=43 24.1%RET Pfizer Eli Lilly RET RocheRET SY-5007 RET II IKL590586 RET I/II I/II49 SKB264 NSCLC ASCO SKB264(TROP2-ADC)NSCLC II SKB264 TROP2 ADC-CL2A-I 7.4 NSCLC 5mg/kg IV Q2W SKB264 8 RECIST 1.1 EGFR TKI NSCLC SKB264/NSCLC TRAE SKB264 TROP2 ADC;III IIIImmunomedics;Seagen;TROP2 ADC;datopotamab deruxtecanAstraZeneca;Daiichi SankyoTROP2 ADC;III III ORR TRAEsImmunomedics;Seagen;19/SKB-264 44 67.4%ORR DoR DCR 1 N=3944%9.3m/2 N=1926%/89%3 N=2060%/100%N=433 TRAEs 67.4%4 TRAEs 50 SYSA1801 CLDN18.2 ASCO SYSA1801 SYSA1801/18.2 SYSA1801 ADC CLDN18.2 CLDN18.2 ADC 3 Q3W SYSA1801 0.5 1 2 2.5 3mg/kg CLDN18.2 ORR DCR 1 N=21 38.1%57.1%2 N=17 47.1%64.7%N=33TRAEs 75.8%3 TRAEs 24.2%CLDN18.2/SYSA1801 SYSA1801;Elevation OncologyCLDN18.2 ADC;I I SO-N102 SotioCLDN18.2ADC;I/II CMG901 CLDN18.2ADC I I ORR AEsSYSA1801 26(78.8%)7(21.2%)11(33.3%)3 38.1%25(75.8%)(TRAEs)8 CMG901 13/14 75.0%3/27(11.1%)(AE)AE 51 PRaG3.0 HER2 Wuerstlein,R et al.Final results of the global and Asia cohorts of KAMILLA,a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer ASCO RC48-ADC PD-1/PD-L1 GM-CSF IL-2 PRaG3.0 HER2 II RC48-ADC HER2 MMAE ADC T RC48-ADC 2.0 mg/kg d1 3/HFRT GM-CSF IL-2 PD-1/L1 RC48-ADC PD-1/L1 6 PD-1/PD-L1 HER2 RC48-ADC 2/3/PRaG3.0 RC48Seagen(Pfizer);HER2 ADCHER2;AstraZeneca;Daiichi SankyoHER2 ADCHER2;ImmunoGen;RocheHER2 ADCHER2 trastuzumab botidotin;HER2 ADC;ORR mPFS TRAEs(3RC48 HER2 38.5%5.3m 6.3%ImmunoGen;RocheHER2/5.7m 48.6%ORR DCR 1 N=26 38.5%69.2%N=322(6.3%)TRAE 52 1353 KN026 KN046 HER2 Meric-Bernstam,Funda et al.Zanidatamab,a novel bispecific antibody,for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers:a phase 1,dose-escalation and expansion study ASCO KN026 KN046 HER2 KN026 HER2 KN046 PD-L1 PD-1 CTLA-4 CD80/CD86 3 HER2(GC/GEJ)BC 6 ORR mDOR mPFS 1 N=26 53.8%6.8m 5.6m 2 N=15 53.3%11.7m 12.2mN=26TRAEs 38.5%3 TRAEs 7.7%KN026 KN046 HER2 KN026+KN046 HER2 II IIzanidatamab HER2 III III ORRTRAEs()KN026+KN046 53.8%7.7%zanidatamab 36%3%54 CT0180 ASCO GPC3 scFv-CD3 T(CT0180)I GPC3 70-80%CD3 scFv T CD3 T/CD3 GPC3 scFv-CD3 T CT0180 25 mg/m2 300 mg/m2 3 i3+3 3 ORR PR SD mOS N=7 28.6%(2/7)28.6%(2/7)42.9%(3/7)11.6m CT0180 28 BB T CT0180 CT0180CAR T I IcodrituzumabChugai;Perseus Proteomicsanti-GPC3 II BOXR1030Sotio;Cogent BiosciencesCAR T;Merkel;I/II 55 CRPC Merseburger,Axel S et al.Continuous enzalutamide after progression of metastatic castration-resistant prostate cancer treated with docetaxel(PRESIDE):an international,randomised,phase 3b study ASCO AR HC-1119 mCRPC III HC