医药行业：ASCO本土创新药重点数据-230605（65页）.pdf

1、丁丹（分析师）电话：0755-23976735证书编号：S：021-38675923S0880521070001 201 3CDK4/6HRHER2HER2HR-/HER2+DAP-HER-01NCT04293276CDK4/6HER()HRHER2ORR70%HR-ORR81.8%HR+55.6%Min YanESMO 2021poster 276P2HER2ABCRECIST 1.1ORRPFSOS2020492021519414019.2G3+G4 TRAEs68.3%65.9%19.5%mPFS=11.0mon95%CI 7.3mon-19.3monHRHRPFS16.6mon95%C

2、I7.3mon-NAHRHRmPFS=9.1mon95%CI5.4mon-11.0monmPFS11.0mon95%CI5.4mon-NA(HER2)+(CDK4/6)IIHER2(DAP-HER-01)01 4(HER2)+(CDK4/6)PLEASURABLE(II)ER+/HER2+01HR+/HER2+MBC+mPFS=11.3mon66.7%RP2D320mg/d125mg/d2.5mg/dXichun Hu,FRONT ONCOL 20222HR+/HER2+ORRPET/CT68Ga-HER2DNADNActDNANGS2023119481735.4%3164.6%ORR=68.

3、1%32/47DCR=100%47/47ORR=81.3%13/16ORR=61.3%19/31cut-off datePFSOS68Ga-HER2N=16mSUV max=7.52.3-34.9N=12mSUV max4.00-14.968Ga-HER2N=8PRN=2n=10ctDNAn=10NGS2BRCABRCA1/2BRCA2TRAEs95.8%G360.4%G46.3%91.7%G345.8%87.5%G32.1%79.2%G34.2%68.8%G32.1%41.7%G32.1%G42.1%5 SHR1701(PD-L1/TGF-)SHR1701BP102()Ib/III01PD-

4、L1SHR-1701PD-L1TGF-RII1b/3SHR-1701IbSHR-170130 mg/kg175 mg/m250 mg/m2/AUC 5BP10215 mg/kgQ3WORR2022226812315527-712477.4%722.6%2064.5%722.6%412.9%G3 TRAEs80.6%(25pts)n=1651.6%n=1238.7%n=825.8%TRAEs25.8%8TRAEsSHR-170126.5%TRAEs3331ORR=77.4%(95%CI:58.9%-90.4%)CR4(12.9%),PR20(64.5%),SD5(15.1%),PD2(6.5%)

5、24DCR=93.5%(95%CI:78.6%-99.2%)3096.8%6mon-PFS=93.5%(95%CI:76.6%-98.3%)6 SHR1701(PD-L1/TGF-)+SHR2554(EZH2)SHR1701(PD-L1/TGF-RII)SHR2554(EZH2)I01PREnhancer of zeste homolog 2EZH2SHR-1701PD-L1/TGF-RIISHR2554EZH21SHR2554300-350mgBID+SHR-170130mg/kgQ3WSHR2554RP2D+SHR-1701SHR-1701SHR2554RP2D20231633n=7n=2

6、6RP2DSHR2554 350mg BID+SHR-1701 30mg/kg Q3W26ORR=57.7%2CRmRCCcHL16r/r cHL1016100%cHLPD1/PD-L11593.8%14cHLORR=100%CR=7.1%TRAEs=40.6%(13/32)21.9%15.6%15.6%G3 TRAEs3.1%3.1%cHLSHR-1701SHR2554NCT04407741 7(c-kit/VEGFR2/PDGFR-)01FAPDTFAPFAP-associated DTsVEGFR-2PDGFRc-kitFGFRRECIST v1.120 mg QDORRPFSQoLEO