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丁丹（分析师）电话：0755-23976735证书编号：S：021-38675923S0880521070001 201 3CDK4/6 HR HER2 HER2 HR-/HER2+DAP-HER-01 NCT04293276 CDK4/6 HER()HR HER2 ORR 70%HR-ORR 81.8%HR+55.6%Min Yan ESMO 2021 poster 276P2 HER2 ABCRECIST 1.1 ORRPFS OS2020 4 9 2021 5 19 41 40 19.2G3+G4 TRAEs 68.3%65.9%19.5%mPFS=11.0mon 95%CI 7.3mon-19.3mon HR HR PFS 16.6mon 95%CI 7.3mon-NAHR HR mPFS=9.1mon 95%CI 5.4mon-11.0mon mPFS11.0mon 95%CI 5.4mon-NA(HER2)+(CDK4/6)II HER2(DAP-HER-01)01 4(HER2)+(CDK4/6)PLEASURABLE(II)ER+/HER2+01HR+/HER2+MBC+mPFS=11.3mon 66.7%RP2D 320mg/d 125mg/d 2.5mg/d Xichun Hu,FRONT ONCOL 2022 2HR+/HER2+ORRPET/CT 68Ga-HER2 DNA DNA ctDNA NGS2023 1 19 48 17 35.4%31 64.6%ORR=68.1%32/47 DCR=100%47/47 ORR=81.3%13/16 ORR=61.3%19/31 cut-off date PFS OS68Ga-HER2 N=16 mSUV max=7.5 2.3-34.9 N=12mSUV max 4.0 0-14.9 68Ga-HER2 N=8 PR N=2 n=10ctDNA n=10 NGS 2 BRCA BRCA1/2 BRCA2TRAEs 95.8%G3 60.4%G4 6.3%91.7%G3 45.8%87.5%G3 2.1%79.2%G3 4.2%68.8%G3 2.1%41.7%G3 2.1%G4 2.1%5 SHR1701(PD-L1/TGF-)SHR1701 BP102()Ib/III01PD-L1 SHR-1701 PD-L1 TGF-RII1b/3 SHR-1701IbSHR-1701 30 mg/kg 175 mg/m2 50 mg/m2/AUC 5 BP102 15 mg/kg Q3WORR2022 2 26 8 12 31 55 27-71 24 77.4%7 22.6%20 64.5%7 22.6%4 12.9%G3 TRAEs 80.6%(25pts)n=16 51.6%n=12 38.7%n=8 25.8%TRAEs 25.8%8 TRAEs SHR-1701 2 6.5%TRAEs 3 331 ORR=77.4%(95%CI:58.9%-90.4%)CR 4(12.9%),PR 20(64.5%),SD 5(15.1%),PD 2(6.5%)24 DCR=93.5%(95%CI:78.6%-99.2%)30 96.8%6mon-PFS=93.5%(95%CI:76.6%-98.3%)6 SHR1701(PD-L1/TGF-)+SHR2554(EZH2)SHR1701(PD-L1/TGF-RII)SHR2554(EZH2)I01PR Enhancer of zeste homolog 2 EZH2SHR-1701PD-L1/TGF-RII SHR2554 EZH21SHR2554 300-350mg BID+SHR-1701 30mg/kg Q3W SHR2554 RP2D+SHR-1701SHR-1701 SHR2554 RP2D2023 1 6 33 n=7 n=26RP2D SHR2554 350mg BID+SHR-1701 30mg/kg Q3W 26 ORR=57.7%2 CRmRCC cHL 16 r/r cHL 10 16 100%cHL PD1/PD-L1 15 93.8%14 cHL ORR=100%CR=7.1%TRAEs=40.6%(13/32)21.9%15.6%15.6%G3 TRAEs 3.1%3.1%cHL SHR-1701 SHR2554NCT04407741 7(c-kit/VEGFR2/PDGFR-)01FAP DT FAP FAP-associated DTsVEGFR-2 PDGFR c-kit FGFRRECIST v1.120 mg QDORRPFS QoL EORTC QLQ C30DT FFPE2021 11 24 2022 8 8 11 9 9.4mon 6.6mon-14.9mon 36 28-5345%9 2 DT 8 stage-DT 102 15 PR 6 SD 7.0mon ORR=45.5%DCR=100%6mon-PFS=91%DT ORR=55.6%6/58.3 75.8 P=0.09&QoL TRAEs 87%1/2 73%64%55%36%/QoL 6 58.3 vs 75.8(P=0.09)11 APC 457 1578 5 DT 547 1896 APCFAP DT 802 9(BTK)r/r DLBCL I02R/R DLBCL/HDT/SCT/+R/R DLBCLNCT04436107R/R DLBCL HDT/SCTPart 1 QD 15mg or 20mg or 25mg 28/day 1-21 160mg BIDPart 2 25mg 160mg BIDPart 1:RP2D Part 2:ORRPart 2 19 25mg RP2D Part1 Part22022 11 8 46 27 in part 1;19 in part 2;30 at RP2D 60 29-82 83%III-IV 37%70%B non-GCB 1 1-53.9mon 0.4-24.9mon 6.6mon 0.5-25.5monORR=46%95%CI 30.9%-61.0%CR=24%RP2D ORR=57%95%CI 37.4%-74.5%CR=30%RP2D GCBORR=61%95%CI 38.5%-80.3%CR=35%GCB ORR=50.0%95%CI 11.8%-88.2%CR=17%RP2D6-mo event-free rate=59%(95%CI 23.8%-82.8%)mPFS=5.5mon 95%CI 2.8mon-NA 9-mo event-free rate=37%95%CI 17.6%-57.4%46 100%1 TEAE RP2D G3 TEAEs 60%43%23%13%1 2%G3 2 TEAE 2Part 1 20mg Part 1 25mg 2 Part 1 20mgPart 2 2 TEAE160mg+25mgNCT04436107 10(BTK)ROSEWOOD02FL Tam Blood Adv 2020 ROSEWOOD NCT033320172+(ZO)vs(O)R/R FL 20.2FL 3L+CD20)(FL 1-3a)2 1+vs160mg QDORRDOR PFS TTNT OS217 ZO 145 O 72 64 217 114 52.5%FLIPI 123 56.7%GELF 3 2-11 114 52.5%214 98.6%(80.6%)94.0%54.8%ZO ORR=69.0%O ORR=45.8%P=0.0012 CR=39.3%ZO CR=19.4%O 18mon-DOR=69.3%ZO 41.9%OmPFS 28.0mon ZO 10.4mon O HR=0.50 95%CI 0.33 0.75 P=0.0007 ZO mTTNT O 12.2 HR0.34 95%CI 0.22 0.52 P 5%6.3%0%6.3%0%13.3%19.7%2.8%9.9%O2.4/100 ZO vs 1.3/100 O 2R/R FL+NCT03332017 11(BTK)MAHOGANY R/R FL R/R MZL+CD20+III02BTK B nHL BTK CLL/SLL WMBTKMAGNOLIA 15 1 CD20 r/r MZL r/r FL ROSEWOODZO ORR R/R FLMAHOGANY BGB-3111-308 NCT05100862 3+CD20+R/R FL MZLFL/MZL FL 1-3A MZL 1 CD20BTKFL 1 1 ZO N=300 N=300 60 vs2 vs IRC PFS IRC ORR OSMZL 1 1+N=75+N=75 60 vs2 IRC PFS IRC ORR160mg BID 320mg QD 812NCT05100862 12 BGB-11417(bcl-2)B Bcl-2 BGB-11417 I02BGB-11417 Bcl-2 I BGB-11417 B2989 ASH 2022 BGB-11417 BBGB-11417-102 NCT04883957 IR/R B 80 160 320 640mg QDBGB-11417 MTD RP2D21 ramp up DLT CTCAE v5.0 CLL AE2022 10 1 54 34 R/R NHL 20 DLBCL 7 FL 4 MZL 3 NHL 20 R/R CLL/SLL 640mg/d640mg MTD 61 31-84 2 1-7 6.6mon 0.2-13.0mon23 22 NHL 1 CLL/SLL 18 PD 4 1TEAE 92.6%G3 TEAE 53.7%TEAE 48.1%G325.9%DLT 80mg/Day 160mg/Day 3 14.8%TEAE 14.8%TEAETEAE/39 27 NHL 12 CLL/SLL 5 NHL 9 CLL/SLL NHL 160mg/d 3 PR 320mg/d 1 PR640mg/d 1 CR CLL/SLL 80mg/d 2 CR 2 PR 160mg/d 3 PR 320mg/d 2 PR 9 R/R CLL/SLL 5 80mg/d 4 160mg/dMRD 3 MRD CLL/10-4uMRD4 1 80mg/d 4.5monuMRD4 2 160mg/d 7.1 mon uMRD4 R/R CLL/SLL RP2D 320mg/d 13 Zanidatamab(HER-2)IIb HERIZON-BTC-01 Zanidatamab HER202/BTC HER2 BTCHER2 Zanidatamab Zani HER2 I BTCIIbHER2 BTC GBC/ICC/ECCHER2Zani 20mg/kg IV Q2WIHC 1 IHC 2+/3+HER2 2 IHC 0/1+RECIST 1.1 81 IRC confirme ORR87 1 n=80 2 n=7 64 32-79 54%66%52%GBC 30%ICC 18%ECC/1 1-71 cORR=41%(95%CI:30%,51%)mDOR=12.9mon 95%CI:5.95mon NA CR=1%PR=40%SD=28%PD=30%DCR=69%(95%CI:57%,79%)12.4mon 2022 10 10 33 49%82%DOR16weeks 1.8mon 1.6mon-5.5mon PFS OS 2TRAEs 72%TRAEs 10%37%33%G3 TRAEs 18%4.6%EF 3.4%3%2 2.3%EF Zani 7TRAEs AE preferred term 1 Zani 4 AE 14 Zanidatamab(HER-2)HER2 Zanidatamab HER2 Ib/II02HER2 HER2 Zani(ZW25)HER2HER2 Ib/II NCT04276493 Zani HER2Zani+HER2+BC 1L/Cohort1a Zani 30mg/kg IV Cohort1b Zani 1800mg IV 75mg/m2IVQ3WORRDOR DCR2022 11 22 37 55.0 33-80Cohort 1a n=10 Cohort 1b n=27 15.5mon 1.1-29.3mon 13 1-37 1848.6%3336 97.3%1 TREAs 25 67.6%G3 TRAEs G3 TRAEs(18 48.6%)(7 18.9%)6 16.2%TRAEsTRAEs 15(TIGIT)AdvanTIG-105(Ib+stage IV GC/GEJ02TIGIT PD-1 AdvanTIG-105 NCT04047862 I/1bTIGIT PD-1+RP2D 900mg IV Q3W+200mg IV Q3WAdvanTIG-105 GC/GEJC 9I/1b/stage IV GC/GEJCGC(RP2D)+q3w for 6 cycle s(RP2D)+q3w for 6 cycles(RP2D)+5-FU q3w for 6 cyclesORRPFS DoR DCR2022 9 29 60 61.5 35-82 31.1 1.4-78.459 ORR=50.8%95%CI 37.5%,64.1%DCR=84.7%95%CI 73.0%,92.8%mDoR=4.6mon 95%CI3.9mon,7.1mon mPFS=8.2mon 95%CI 5.8mon PD-L1 TAP 5%n=27ORR=59.3%95%CI 38.8%,77.6%PD-L1 TAP 5%n=28 ORR=50.0%95%CI 30.7%,69.4560 1 TEAE 43.3%41.7%G3 TEAEs 71.7%43 2846.7%TEAEs 5 8.3%TEAEs 2 3.3%16BGB-A445(OX40)BGB-A445(OX40)BGB-A445 I02OX40 CD4+CD8+T T BGB-A445 OX40OX40 BGB-A445-PD-1 mAb I/NCT04215978 BGB-A445 TISI/7 BGB-A445 A 5 21 1 BGB-A445+TIS200mg B mTPI-2PK RECIST v1.12022 8 31 A 59 B 32 A B 59 28-80 61 37-7526 44%13 41%A 50 2 unconfirmed PR 4%)18 SD 36%26 PD 52%B 30 7 confirmed PR23%13 confirmed SD 43%8 PD 27%3 G3 TEAEs A 23 39%TEAEs B 16 50%TEAEs A 1 2%TEAE B 0%A 11 19%imAEs G3 imAEs B 14 44%imAEs 1 3%G3 imAEs/1703 18 IBI-351(KRAS G12C)I pooled analysis IBI351(GFH925)KRAS G12C mCRC03IBI-351 GFH925 KRAS G12C INCT05005234 NCT05497336 IBI351 GFH925 KRAS G12C mCRCI(NCT05005234 NCT05497336)KRAS p.G12C mCRCIBI-351 700mg PO QD 450/600/750mg PO BIDORR45 58.0 57.8%71.1%ECOG PS=1 66.7%2L700mg QD 3 450mg BID 4 600mg BID 37 750mg BID 1=84 36 80.0%1450mg BID 2862022 12 15 ORR=47.5%19/40 95%CI 31.5%-63.9%DCR=85.0%95%CI 70.2%-94.3%DOR 600mg BID 32 ORR=43.8%14/32 DCR=87.5%40 88.9%TRAEs 9 20.0%G3TRAEsIBI-351 GFH925 KRAS G12C mCRC 19 IBI-110(LAG-3)Ib IBI110(LAG3)1L HCC03+HCC PD-1 LAG-3 IBI110+IBI110 1L HCCIb NCT04085185IBI110+IBI110:200mg IV Q3W:200mg IV Q3W:8mg(60kg)/12mg(60kg)PO QD2023 1 9 28 59 6 ECOG PS=0 13 BCLC C28 27 96.4%TRAEs 50%42.9%39.3%16 57.1%G3 TRAEs 4 14.3%G3 irAEs 2 7.1%2/28 TRAE 127 ORR=29.6%95%CI 13.8%-50.2%DCR=85.2%95%CI 66.3%-95.8%1112.2mon mPFS=9.9mon 95%CI 5.7mon-NC 9-mo PFS=54.5%95%CI 33.8%-71.2%mOS 20 IBI-110(LAG-3)Ib IBI110(LAG3)HER2 1L GC/GEJ03G/GEJ AC+(XELOX)PD-1 LAG-3IBI110+XELOX 1L G/GEJ AC Chenyu Mao ASCO 2022Ib NCT04085185/HER2(-)GC/GEJ ACIBI110+XELOX IBI110:200mg IV Q3W;:200mg IVQ3W;:130mg/m2 Q3W;:1000mg/2/BID2023 1 9 17 61 14 ECOG PS=1TRAEs TRAEs 64.7%52.9%52.9%11 64.7%G3 TRAEs G3 TRAEs TRAEs 10 58.8%irAEs 317.6%G3 irAEs17 unconfirmed ORR=88.2%95%CI 63.6%-98.5%confirmed ORR=64.7%95%CI 38.3%-85.8%DCR=94.1%95%CI 71.3%-99.9%13.1mon mDoR=11.6mon 95%CI 2.5mon-14.4mon mPFS=12.9mon 95%CI 3.8mon-15.8mon12mo-OS=70.6%95%CI 43.1%-86.6%21 IBI-939(TIGIT)Ib IBI939(TIGIT)1L PD-L1 NSCLC03TIGIT IBI939 TIGIT+PD-L1 TPS50%NSCLCPFS Ying Cheng et al.ESMO-IO,2022I NCT04672369 NSCLC PD-L1 TPS50%2:1 A IBI939 20 mg/kg+200 mg Q3W B 200 mg IV Q3WORRPFS OS42 A 28 65 n=19 n=7 B 14 58 n=6n=1 2023 1 1 A mPFS=12.2mon 95%CI 11.1mon-13.9mon B mPFS=11.3mon 95%CI 10.8mon-13.6mon A mPFS=13.2mon 95%CI 6.7mon-16.5mon B mPFS=6.4mon 95%CI 1.4mon-NA HR 0.62 95%CI 0.26-1.4342 TRAEs A 96.4%B78.6%A 5 B 6 G3 TRAEs A 3 10.7%B 4 28.6%G3 irAEs irAEsTEAE A TEAE B G5 TEAEIBI939+PD-L1 TPS50%NSCLC PFS 22 CT103A(BCMA CAR-T)Ib/II FUMANBA-1 CT103A(BCMA CART)R/R MM03CT103A BCMA CAR R/R MM Ib/IIFUMANBA-1I/II(NCT05066646)R/R MMCT103A 1.0 1 06CAR-T/Kg2022 9 9 103 RRMM 53.4%58.0 CT103A(Ib 17;II 86)=13.8mon4101 16 ORR=96%CR=74.3%mDOR mPFS 12mo-PFS=78.8%95%CI68.6%-85.97%BCMA CAR-T N=89 ORR=98.9%CR=78.7%BCMA CAR-T CT103A6 N=81 ORR=98.8%C R=80.2%BCMA CAR-T 4/5(80%)sCR 18sCR 101 95%MRD MRD=14 CR/sCR MRD 82.4%95%CI 70.90%-89.72%12 MRD 64th ASH CRS ICANSG3 TRAEsPK/PD CT103A 12 87570.6 copies/g gDNA 12mon 50.0%(28/56)CT103A100 copies/g gDNA 24mon 40.0%4/10 20/103(19.4%)=13.8mon CT103A MM BCMA CAR-T18 sCR CT103A 2304 24 AK104(PD-1/CTLA-4)AK104 1L GC/GEJ Ib/II04PD-1+G/GEJ 1L OS PFS PD-L1 CPS5PD-1 CTLA-4 Ib/II PD-1/CTLA-4AK104 XELOX XELOX mXELOX G/GEJ 1LIb/II(NCT03852251)G/GEJ(HER2+PDL1AK104+XELOX/mXELOX AK104 4mg/kg 6mg/kg 10mg/kg Q2W 10mg/kg 15mg/kg Q3W mXELOX Q2W XELOX Q3WORR2022 10 31 98 4 10mg/kg Q3W III62.7 70.2%62.8%ECOG PS=1 45.7%24.0mon 0.5mon-33.3mon88 94%ORR=68.2%60/88 CR=5.7%5/88 PR=62.5%55/88 DCR=92.0%81/88 mDoR=9.69mon 95%CI 5.82mon-14.00mon mPFS=9.20mon 95%CI 6.67mon-10.48mon mOS=17.41mon 95%CI 12.35mon-29.77mon PD-L1 mOS=20.24mon PD-L1 CPS5 mOS=17.28mon PD-L1 CPS 597.9%TRAEs 62.8%61.7%59.6%51.1%33.0%30.9%30.9%69.4%G3 TRAEsG/GEJ AK104+mXELOX/XELOX AK104+1LAK104 G/GEJ 1L III NCT05008783 25 AK112(PD-1/VEGF)II AK112(SMT112)EGFR/ALK 1L NSCLC04+NSCLC+PD1 AK112PD-1/VEGF VEGF PD-1VEGF AK112 PD-1 10 AK112 1/2=67 1/2=20AK112+/sq/nsq NSCLC 1LII NCT04736823 NSCLC EGFR/ALK 3 2022ASCO NSCLC EGFR/ALKAK112+AK112 10mg/kg Q3W 20mg/kg Q3WAK112+AK112 10mg/kg Q3W 20mg/kg Q3WORR135 NSCLC AK112+63 72 61 78%3%ECOG PS=097%ECOG PS=1 20%)=11.5monORR=75%mDOR=15.4mon DCR=95%9mo-PFS=67%9 mo-OS=93%ORR=55%DOR DCR=100%9 mo-PFS=61%9mo-OS=81%TRAEs 10%ALT AST28.1%G3 TRAE 6.7%TRAEAK112+EGFR/ALK/NSCLC 26 AK117(CD47)AK104 AK117(CD47)1L GC/GEJ04PD-1+G/GEJ 1L PD-L1 CPS5 AK104 PD-1/CTLA-4G/GEJ ASCO GI 2022#308 AK117 IgG4 CD47AK117 CD47/SIRP AK104 AK117+G/GEJ 1LII NCT05235542 G/GEJAK104+AK117+XELOX+)(AK104 10mg/kg D1 Q3W AK117 45mg/kg D1 QW 45mg/kg D1 Q3W 130mg/m2D1 Q3W 1000mg/m2BID D1-14 Q3W)ORRDoR DCR TTR PFS OS2022 8 4 2023 1 13 16 G/GEJ 64 75%88%ECOG PS=1100%75%2 25%2.6monTRAEs 43.8%7/16 G3 TRAEs 25%4/16 G3 TRAEs 18.8%3/16 G4 TRAEs 6.3%1/166.3%1/16 TRAEs TRAEs 10%AK104+AK117 45mg/kg D1 QW+XELOX 8 ORR=75%6 PRs 5 62.5%50%DCR=100%8/8 DoRHER2(-)G/GEJ AK104+AK117+2705 28 Tifcemalimab(BTLA)Tifcemalimab(ES-SCLC)I/II06BTLA B T NK BTLA PD-1 T TifcemalimabJS004/TAB004 S228P IgG4 BTLA HVEMI tifcemalimab PD-1I/II NCT05000684 ES-SCLCTifcemalimab+Tifcemalimab 200mg IV Q3W 240mg IV Q3W22023 1 31 43 ES-SCLC 60.0 1 14 32.6%PD-1/L1=12.1w32 74.4%TEAEs 12 27.9%G3 TEAEs TEAEs 16.3%14%14%14%3 7.0%TRAEs TRAEs15 34.9%irAEs 2 4.7%G3 irAEs38 ORR=26.3%DCR=57.9%ORR=8.3%ORR=40.0%70.0%DoR HVEM PD-L1Tifcemalimab ES-SCLC 2906 30 RC48(HER-2 ADC)Ib/II RC48 UC07(la/mUC)(RC48)RC48 PD-1Ib/II NCT04264936/1LRC48+RC48 1.5mg/kg 2mg/kg Q2W 3mg/kg Q2W41 la/mUC 22 66 61%54%24%2%UC 59%HER2 IHC 2+/3+32%PD-L1 RC48 2mg/kg+3mg/kg Q2W2022 11 18 confirmed ORR=73.2%95%CI:57.1%-85.8%CR=9.8%ORR=76.0%HER-2 ORR=83.3%HER2 IHC 3+/2+ORR=64.3%IHC 1+ORR=33.3%IHC 0 PD-L1 ORR=61.5%PD-L1+ORR=78.6%PD-L1-DCR=90.2%95%CI,76.9%97.3%mPFS=9.2mon 95%CI:5.7mon-10.3mon 2yr-OS=63.2%TRAEs AST/ALT 68.3%61.0%61.0%-56.1%53.7%51.2%G3 TRAEs 43.9%23 56.1%irAE 14.6%G3RC48-ADC la/mUC III 3107 32Heav ily pretreated RRMM mOS 12mon 1b/2 CARTITUDE-1(NCT03548207)ciltacabtageneautoleucel(cilta-cel)BCMA CAR-T 27.7mon ORR=98%sC R=83%27mon-PFS=55%27mon-OS=70%1b/2 CARTITUDE-1(NCT03548207)3(LOT)(PI)(IMiD)PIIMiD CD38ciltacabtagene autoleucel(cilta-cel)ORRPFS OS(MRD)(negativityat10-5)97 cilta-cel 61 6 42%88%99%2022 10 14 33.4mon 1.5mon-45.2mon33.9mon 95%CI 25.5monNE mPFS=34.9mon 95%CI 25.2monNE36mon-PFS=47.5%mOS 36mon-OS=62.9%49 MRD 26MRD 12mon 20 MRD CR mPFS 324mon 18 MRD CR27.7mon6 2 B1 5 PD n=3 n=1cilta-cel 35 PD n=17 cilta-cel n=12 n=6r/r MM cilta-cel mPFS CR/MRD PFS 15 CARTINUE(NCT05201781 MMY4002)Cilta-cel(BCMA CART)CARTITUDE-1 cilta-cel heavily pretreated RRMM 1b/201 33LCAR-B38M CAR-T CAR CAR 4-1BB 2 BCMA LEGEND-2 LCAR-B38M1 74 r/r MM 1b/2 CARTITUDE-1 2 CARTIFAN-1 LEGEND-2LEGEND-2 5 BCMA CAR-T1/2 300mg/m2(n=66)250 mg/m225 mg/m2(n=8)LCAR-B38M CAR-T0.51x106cells/kg(0.07-2.10 x106)CART(n=9)3(n=65)2016 3 30 2017 11 26 2022 11 30 65.4mon0.4mon-78.8mon 74 LCAR-B38M 54.5 60.8%3(1-9 44.6%ISS stageI 28.4%ISS stageIII 29.7%EMD 35.7%CAR-TORR=87.8%CR=73.0%MRD CR=67.6%mDOR=23mon mPFS=18mon PFSmOS 65.4mon mOS=55.8mon 33(44.6%)13(17.6%)PD PDECOG PS 0 IgG MM ISS stageI MM MMEMDLEGEND-2 5 mOS=55.8mon 18%RRMM Cilta-cel(BCMA CART)LEGEND-2 5 LCAR-B38M CAR-T RRMM01 34Cilta-cel 2022 FDA RRMM cilta-cel12 2022 12 31 177 139 cilta-cel(EMD 35%)(41%)55%CARTITUDE-1(19%)BCMA(14%)(12%)(13%)(8%)83%ORR=28%81%+11%4%4%+CAR-T60w/kg 0.1-0.9 19%expanded access protocol2.3mon 0mon-8mon CRS 81%3 7%ICANS 22%3 8%61%44%10%9%8 23 30 Gr3 75%32%30(N=115)(N=118)PR 75/80%very good PR 44/62%CR 26/40%EAP FluCy(N=88)ORR/CR 89/49%17 413(9%)5 CRS 3 6 CRS/1 5 ICANS 1NT 2cilta-cel ORR(80%)FluCyconforming products(89%)9%NT Cilta-cel(BCMA CART)Cilta-cel RRMM01 3508 36 SKB-264(TROP2 ADC)SKB264(TROP2-ADC)NSCLC II05TROP2 NSCLC SKB264 TROP2 ADC-CL2A-belotecan I 7.4 DAR ADCII SKB264 NSCLC TROP2TROP2/I/II NCT04152499/NSCLCNSCLC SKB264 5mg/kg IV Q2W 8 RECIST 1.1RECIST 1.12023 2 9 11.5 39 NSCLC SKB2645mg/kg Q2W ORR=44%17/39 DCR=95%37/39 mDoR=9.3mon 6mo-DoR=77%EGFR EGFR-TKI 50%ORR=60%12/20 DCR=100%20/20 mPFS=11.1mon 9mo-PFS=66.7%EGFR PD-L12 ORR=26%5/19 DCR=89%17/19 mPFS=5.3mon 9mo-OS=80.4%G3 TRAEs 5%SKB264 23.3%TRAEsTRAEs LD/NSCLC SKB264 SKB264 NSCLC III 37 KL590586(RET)RET KL590586 RET I05KL590586 A400/EP0031 RET SRI SRII/II KL 400-I/II-01 NCT05265091 I KL 590586 RETPKI/II NCT05265091 RETKL590586 6(10mg-120mg QD)MTD RP2DPK ORR DCR DoR2022 12 30 87 RET 6 10mg-120mg QDDLT MTD TRAEs 93.1%81/87 G1-2 25%TRAEs AST 50.6%ALT48.3%33.3%32.2%32.2%31%G3 TRAEs 24.1%3 TRAEs ALP2.3%GGT 2.3%2.3%TRAEs 4.6%6.9%A400 QT5%69 40mg-120mg 57 NSCLC 10 MTC 1 1ORR=64%58/69 11 228%PD-1/PD-L1 ORR=63%20/32 1 CR DCR=91%mDoR 9 SRI 710%-69%3 PR 4 SD 11 5 2 1 80%1 47%DCR 100%NSCLC ORR=76%19/25 1 CR DCR=92%43 PR CRKL590586 RET SRI/NSCLC 3809 39 ALMB-0168(Cx43)ALMB-0168 Cx43 I0143(Cx43)ALMB-0168 Cx43 临床前研究显示，其可抑制骨癌及乳腺癌骨转移的生长及转移。2022 8 21 14 10 4 27.5 16-38 ECOGPS 7(50.0%)0 6 1(42.9%)12(7.1%)5 2(1-24mg/kg)TRAEs 71.4%10 1 G3,G4 G5 TRAEs(10%)(21.4%)(21.4%)(14.3%)(14.3%)Cx4313 ORR=15.4%2/13 95%CI 1.9%45.5%2 PR 6mg/kg 18mg/kg 1 6mg/kg 3SD=33w PR 8+DCR=53.8%7/13 95%CI 25.1%80.8%2 PR 5 SDI ALMB-0168RP2D:NCT04886765.I/II 该项试验入组16岁或以上经过标准化疗后有进展、经组织学证实的骨癌患者3RECISTv1.1 ORR DCR 40 SYA1801(Claudin18.2 ADC)FIH SYSA1801(CLDN18.2 ADC)/01SYSA1801 CLDN18.2 MMAE ADC CLDN18.2ADC SYSA1801
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