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ASCO 2023：ADC 发 布 日期：2023 年5 月29 日证 券 研 究 报告 医 药 行 业深度 研 究 贺菊颖SAC编号：S1440517050001SFC编号：ASZ591阳明春SAC编号：S1440521070004袁清慧SAC 编号：S1440520030001SFC 编号：BPW879研究助理：魏佳奥研究助理：王云鹏 ASCO 2023 ADC ASCO 2023 ASCO 6 2-6 5 ASCO ADC ADC/ADC ADC Oral LBA Optune Oral LBA A 2 XVFUwPqNnOoPpRsRsPpQrQ6M8QaQoMrRoMmPkPqQtOkPnOrR8OqQxPuOtQnRvPoNqR 5 2ADC 4/6 ADC 7 1ASCO ADC 3 4 ASCO ADC 1 5单抗 小分子 ADC 细胞治疗 双抗 ADC ASCO ADC ASCO LBA ASCO 104 ADC 15 6 3 ASCO 2023ASCO 2023ASCO ASCO6ASCO公司 产品 适应症 临床阶段 类型恒瑞医药 SHR-1701(PD-L1/TGF-RII)宫颈癌 phase Ib/III Poster Session恒瑞医药SHR-1701（PD-L1/TGF-RII）+SHR2554（EZH2）淋巴瘤 phase I Oral Abstract Session信达生物 IBI-110 胃癌 Phase I Poster百济神州 BGB-11417（Bcl-2）非霍奇金淋巴瘤 Phase I Poster百利天恒 BL-B01D1（EGFR/HER3 ADC）局部晚期或转移性实体瘤 Phase I Oral Abstract Session科伦药业 SKB-264 NSCLC Phase I Poster金斯瑞/传奇生物 Cilta-Cel 多发性骨髓瘤 Phase III Oral LBA再鼎医药/Novocure Optune NSCLC Phase III Oral LBA迪哲医药 Sunvozertinib(EGFR ex20)EGFR 外显子20 插入突变的NSCLC phase II Oral Abstract Session迪哲医药 Golidocitinib(JAK1)难治性或复发的周围t 细胞淋巴瘤 phase II Oral Abstract Session首药控股 SY-5007（RET）晚期 RET 阳性实体瘤 Phase I Poster 7/2 ASCO ASCO 81b/3 SHR-1701(PD-L1/TGF-RII)BP102()ORR 77.4%DCR 93.5%6 PFS 93.5%CR 4 PR 20 SD 5 PD 2 30(96.8%)20(64.5%)7(22.6%)4(12.9%)25(80.6%)3(TRAEs)(n=16,51.6%)(n=12,38.7%)(n=8,25.8%)TRAEs 8(25.8%)2(6.5%)TRAEs(3 3)SHR-1701 SHR-1701 BP102 3 All pts(n=31)Best overall response n(%)CR 4(12.9%)PR 20(64.5%)SD 5(15.1%)PD 2(6.5%)ORR,%(95%CI)77.4%(58.9-90.4)DCR,%(95%CI)93.5%(78.6-99.2)6-month PFS rate,%(95%CI)93.5%(76.6-98.3)ASCO ASCO 9I SHR-1701(PD-L1/TGF-RII)SHR-2554(EZH2)(n=26)ORR 57.7%2(cHL)(CR)16(100%)cHL PD-1/PD-L1 10 15(93.8%)14 cHL ORR 100%CR 7.1%RP2D SHR2554 350mg bid+SHR1701 30mg/kg q3w 32 13(40.6%)(21.9%)(15.6%)(15.6%)3 TRAE(3.1%)(3.1%)SHR-1701 SHR-2554 cHL ASCO ASCO 10II SHR-1316(ES-SCLC)ORR 74.5%41/55 DCR 96.4%53/55 PFS 7 CI:4.3-9.7(AE)47(74.6%)35(55.6%)3 4 AE 3 4 AE(27 42.9%)(13 20.6%)(5 7.9%)(46.3%)(3 4.8%)(2 3.2%)SHR-1316 ES-SCLC ASCO ASCO 11II 36 ORR 44.4%(95%CI:27.9%61.9%)DCR 88.9%(95%CI:73.9%96.9%)2 14 16 PFS 6.4(95%CI:5.2,13.0)19(52.8%)3-(8 22.2%)(4 11.1%)(4 11.1%)(4 11.1%)6(16.7%)1 2 ASCO ASCO12BGB-A445 OX40 Tislelizumab Part A:BGB-A445 vs Part B:BGB-A445+Tislelizumab Part A n=50 Part B n=30 2 4%7 23%18 36%13 43%26 52%8 27%Part A Part B 24 41%17 53%3 TEAEs 3 TEAEs Part A 23 39%TEAEs Part B 16 50%Part A 1 2%Part B 0 0%Part A 11 19%imAEs 3 imAEs Part B 14 44%imAEs 1 3%3 imAEs BGB-A445 TIS ASCO ASCO13 HER2 BTC Zanidatamab Cohort 1 cORR 41%(DOR)12.9(m;95%CI:5.95);12.4 2022 10 33 49%82%DOR16 1.8 m(1.6-5.5)(N=87)72%(TRAEs);10%TRAEs(37%)(33%)18%3 TRAEs 3%(4.6%)(EF)(3.4%)2(2.3%)AE(EF)Zanidatamab 7 TREA 1 AE Zanidatamab 4 AE HER2 Zanidatamab HER2 BTC Zanidatamab HER2 BTC tx Cohort 1 n=80 Cohort 2 n=7 cORR,%(95%CI)41(30,53)0(0,41)Confirmed Best Objective Response,n(%)CR 1(1)0PR 32(40)0SD 22(28)1(14)PD 24(30)3(43)Disease Control Rate,%(95%,CI)69(57,79)43(10,82)ASCO ASCO14BGB-11417 Bcl2 B 39(27 NHL;12 CLL/SLL)5 NHL 9 CLL/SLL(NHL:(PR)3 320 mg/d 1(CR)1 640 mg/d;CLL/SLL:2 CR 2 PR 80 mg/d,3 PR 160 mg/d,2 PR 320 mg/d)9 R/R CLL/SLL(5 80mg/d,4 160mg/d)(MRD);3 MRD,CLL/10-4(uMRD4;1 4.5 80 mg/d uMRD4;2 160 mg/d 7.1 uMRD4 R/R CLL/SLL RP2D 320 mg/d TEAE(48.1%);3(25.9%)80 mg/d 160 mg/d 3 DLTs;14.8%TEAE,14.8%TEAE TEEA/BGB-11417 640 mg/d BGB-11417 R/R CLL/SLL ASCO ASCO15 Ociperlimab BGB-A1217 TIGIT Tislelizumab I 1 450 mg OCI 9 36(OCI 150 mg 1)OCI OCI TIGIT 50mg 20 1 AE(TEAE)TEAE2;(6)(4)TEAE4 TEAE 2 3()OCI TIS RP2D OCI 900 mg+TIS 200 mg Q3W LAG3 PFS 12.9 ASCO16+IBI110 LAG3+XELOX HER2 IBI110 200mg Q3W+200mg Q3W+XELOX(130 mg/m2 Q3W+1000mg mg/m2 BID ORR 88.2%ORR 64.7%DCR 94.1%13.1 mDoR 11.6 mPFS 12.9 mOS 12 OS 70.6%TRAE 100%3 TRAEs 64.7%3 irAEs 17.6%LAG3 TIGIT KRAS G12C LAG3 PFS 9.9 ASCO17+IBI110 LAG3+Ib IBI110 200mg Q3W+200mg Q3W+QD ORR 29.6%DCR 85.2%12.2 mPFS 9.9 9 PFS 54.5%mOS.TRAE 96.4%3 TRAEs 57.1%7.1%1 LAG3 TIGIT KRAS G12C KRAS G12C ASCO18GFH925 KRAS G12C IBI351(GFH925)700mg QD,450/600/750mg BID 45 700mg QD 3 450mg BID 4 600mg BID 37 750mg BID 1 84 2022 12 15 ORR 47.5%DCR 85%13.1 mDoR 600mg BID 32 ORR 43.8%DCR 87.5%TRAE 88.9%3 TRAEs 20%IBI-351 NSCLC CRC 2023 LAG3 TIGIT KRAS G12C TIGIT PD-L1 NSCLC 1 PFS ASCO19IBI939 TIGIT+NSCLC PD-L1 TPS 50%,NSCLC 2:1 A IBI939 20 mg/kg+200 mg Q3W B 200 mg Q3W 42 28 IBI939+14 2023 1 1 A 12.2 B 11.3 A PFS 13.2 B PFS 6.4 HR 0.62 TRAE 96.4%vs 78.6%3 TRAEs 5 vs 6 3 irAEs 10.7%vs 28.6%1 A 1 B 2 A Tigit+PD-1 B PD-1 28 14 PFS 13.2 6.4HR 0.62 LAG3 TIGIT KRAS G12C ASCO ASCO20AK104 PD-1/CTLA-4 Ib/II 62.7 29-75 70.2%62.8%ECOG 1 45.7%24.0 0.5-33.3 88 94%ORR 68.2%88 60 5 5.7%55 62.5%DCR 92.0%88 81 DoR 9.69 95%CI 5.82-14.00 PFS 9.20 95%CI 6.67-10.48 OS 17.41 95%CI 12.35-29.77 PD-L1 CPS5 CPS 5 20.24 17.28 TRAEs 97.9%62.8%61.7%59.6%51.1%33.0%30.9%30.9%69.4%3 AK104 mXELOX/XELOX/AK104+/AK104 III NSCLC ASCO ASCO21ivonescimab(AK112/SMT112)PD-1/VEGF EGFR/ALK AGA NSCLC II 61 78%3%ECOG PS 0 97%1 20%11.5 ORR 75%DOR 15.4 95%DCR 9 PFS OS 67%93%ORR 55%DOR DCR 100%9 PFS OS 61%81%TRAEs 10%28.1%TRAEs 3 6.7%TRAE Ivonescimab EGFR/ALK/NSCLC SCC non-SCC NSCLC ASCO ASCO 22 BTLA 25 2023 ASCO BTLA tifcemalimab ASCO Tifcemalimab+ES-SCLC I/II tifcemalimab 200mg Q3W 240mg,Q3W 38 ORR 26.3%DCR 57.9%ORR 8.3%ORR 40.0%12 27.9%3 TEAE 3 7.0%TRAE 2 4.7%3 irAE TNBC III NSCLC II/III EGFR/ALK NSCLCIII OS OS 23.8 vs 17.0 27%HR=0.73)P=0.0108 NSCLC OS HR=0.50 3 AE 78.9%vs 82.1%ASCO ASCO 23 GB263T GB263T GB263T GB263T EGFRm NSCLC I/II GB263T EGFR cMET VHH cMET VHH VHH VHH cMET 2023 2 7 6 140 n=1 420 n=1 840 n=3 1260 n=1 1260 EGFR-TKI 49.5 2-113 DLTs TRAEs 1/2 50%33%17%17%GGT 17%17%17%5 3 60%SD 3 SD 17%3 SD Bicara Therapeutics/Merck ASCO 24Bicara Therapeutics/Merck EGFR/TGF BCA101 K 20(n=13,65%)66(:31-77)(10.50%)(70%HPV/p16-pos)(7.35%)(/:3)15(75%)I(ORR)44%(8 PR,4 SD)(CBR=PR+SD)67%;58%hpv(DOR)6.7(:2.7-11.0+)10;1(PD)(n=1)4 3(TRAEs)(20%)TRAE(15.75%)8(44%)PD-L1 CPS 0-19,10(56%)20 BCA101+P I hpv R/M HNSCC PR SD PD ORR CBR(PR+SD)HPV-neg(n=12)7 3 2 7/12(58%)10/12(83%)HPV-pos(n=6)1 1 4 1/6(17%)2/6(33%)Total(n=18)8 4 6 8/18(44%)12/18(67%)DLL3/CD3 ASCO 25 3(DLL3)/CD3(IgG-like)T BI 764532 DLL3(DLL3+)(SCLC)(NEC)90 1 BI 764532(RA:n=24,8;RB1:n=10,3;RB2:n=56,6;:0.03 g/kg)ECOG(PS)0:1=24%:74%;PD1/PD-L1(Tx):40%;2 prior lines of Tx:69%SCLC:NEC:LCNEC()=52%:41%:4%Tx:43(1-443)1 RA DLTs(3)4 RB2 DLTs(4 CRS);3 CRS,3 2)(AE):CRS(58/2%);(19/0%);(18/14%);(17/1%);(14/0%)CRS/IL-6R RB2 CRS 70(RA/RB1/RB2:n=19/8/43)BI 764532 SCLC(n=24)NEC(n=23)ORR 33%22%LCNEC(PR)BI 764532 SCLC NEC LCNEC Bicara Therapeutics/Merck 26 ADC 3 ASCO ASCO27HER3-DXd(MBC)II ORR 35%(95%CIs 23.1,48.1)CBR 48%(95%CIs 35.2,61.6)HER3 75%ORR 33%CBR 50%HER3 25-74%ORR 46%CBR 54%4 HER3 25%DOR 10.0 mos(95%CIs 5.5,NA)PFS 6month 60%HER375%50%HER3 25-74%70%93%AE(TRAE)19(32%)TRAE 3 TRAE(25%)(50%)(45%)(37%)(32%)(30%)7(12%)AE(SAE)4(7%)SAE(/)15%23%AE 3 2 1 HER3-DXd HER3 HER3 MBC HER2&HER3 ASCO ASCO,28Trastuzumab Deruxtecan(T-DXd)HER2/(HER2+)(mCRC)5.4 6.4 mg/kg T-DXd 41/83(49.4%)23/39(59.0%)3(AE)5.4 mg/kg 6.4 mg/kg 20/83(24.1%)12/39(30.8%)T-DXd 5.4 6.4 mg/kg HER2+mCRC 5.4 mg/kg T-DXd HER2 RAS T-DXd 5.4 mg/kg HER2&HER3 5.4 mg/kg T-DXdn=826.4 mg/kg T-DXdn=40Median follow-up,mo(range)8.9(0.5-17.1)10.3(0.7-16.4)Median DoR by BICR,mo(95%CI)5.5(4.2-8.1)5.5(3.7-non-evaluable)Median PFS,mo(95%CI)5.8(4.6-7.0)5.5(4.2-7.0)Best overall response by BICR in subgroups,n/N(%)95%CIPrior anti-HER2 therapy7/17(41.2)18.4-67.14/10(40.0)12.2-73.8HER2 IHC 3+30/64(46.9)34.3-59.810/34(29.4)15.1-47.5HER2 IHC 2+/ISH+1/18(5.6)0.1-27.31/6(16.7)RAS wt27/68(39.7)28.0-52.311/34(32.4)17.4-50.5RASm4/14(28.6)8.4-58.10/6 ASCO ASCO 29 Dato-DXd(Pt-CT)(aNSCLC)1L Dato-DXd+pembro ORR 60%(95%CI,36%-81%;122/20)Dato-DXd+pembro+Pt-CT ORR 55%(95%CI,39%-70%;235/42)ORR 38%95%CI 25%-54%182/47 47%95%CI 34%-60%285/60 85%3 PD-L1 tx 95%CI 10.8 8.3-15.2 7.8 5.5-NE TEAEs(45%)(45%)61%3 TEAE(8%)(8%)TEAE 31%24%(16%Dato-DXd)6%17%TEAE Dato-DXd 12(10%;9 gr 1/2;3 gr 3)Dato-DXd+pembroo Pt-CT ADC+Pt-CT aNSCLC 1L HER2&HER3 ASCO ASCO 30 LAG-3 PD-1 PD-1 ORR 61.2%12 48 DOR mDOR NR 95%CI:22.6 NE PFS mPFS KM 15.3 95%CI:9.4NE adj-Tx ORR mDOR mPFS 60.9%14/23 NR 13.3 PD-1 adj-Tx ORR mDOR mPFS 61.5%8/13 NR 11.8 43.9%32.7%65.3%3 TEAE TEAE AE 16.3%TEAE Tx irAE PD-1 AI 12.2%4.1%3 Fianlimab+cemiplimab Mel LAG-3 Mel ORR AI+PD-1 HER2&HER3 ASCO ASCO 31 TROP2 ADC ASCO SKB264 TROP2 ADC)II 5 mg/kg Q2W11.5 39 ORR=44%DCR=95%DoR=9.3 EGFR-tki 20 ORR=60%DCR=100%mPFS=11.1 9 PFS=66.7%EGFR 19 ORR=26%DCR=89%PFS=5.3 9 OS=80.4%3 TRAEs A400 RET RET I 6(10mg-120mg QD)/69 57 NSCLC 10 1 1 ORR=64%32 ORR=63%DCR=91%DoR NSCLC 25 ORR=76%DCR=92%4()3 PR CR(DLT)(MTD)3 TRAEs 24.1%3 TRAEs ALP(2.3%)GGT(2.3%)(2.3%)ADC MSD ASCO MSD TROP2 ADC(SKB264)RET A400 SKB264 NSCLC ORR 44%DoR 9.3 EGFR-tki orr 60%9 PFS 80.4%A400RET ASCO 69 ORR 64%ASCO ASCO32BL-B01D1 EGFRxHER3-ADC I 3.0mg/kg QW 3.5mg/kg D1D8 Q3W DLT MTD 3.0mg/kg D1D8 Q3W 6.0mg/kg D1 Q3W TRAEs 10%/G3 60%/30%51%/34%45%/15%44%/19%30%/0%29%/1%28%/0%21%/1%22%/1%21%/1%16%/0%15%/2%15%/1%13%/0%ILD BL-B01D1/EGFR ADCNSCLC(EGFRmut)(n=34)NSCLC(EGFRwt)(n=42)(SCLC)(n=7)(NPC)(n=24)HNSCC(n=13)Median prior treatment line(range)4(1-7)2(1-8)2(1-2)3(1-9)3(1-7)Best overall response,ncPR 15 7 1 3/PR 6 10 0 8 1SD(n with shrinkage)10(10)23(16)5(4)13(12)9(8)PD 3 2 1/3ORR,%61.8 40.5 14.3 45.8 7.7(95%CI)(43.6-77.8)(25.6-56.7)(0.4-57.9)(25.6-67.2)(0.2-36.0)DCR,%91.2 95.2 85.70%100%76.90%(95%CI)(76.3-98.1)(83.8-99.4)(42.1-99.6)(85.8-100)(46.2-95.0)ASCO ASCO 33 RC48 RC48 ASCO RC48 ADC/ASCO RC48 Ib/II 1.5-2.0mg/kg RC483mg/Kg ORR=73.2%,CR=9.8%,DCR=90.2%,mPFS=9.2 mo,2-year OS rate=63.2%3 43.9%RC48HER2 II PD-1/L1 GM-CSF IL-2 32 ORR=38.5%DCR=69.2%mPFS=7.2 mo3 6.3%RC48 I 19 ORR=78.9%12 CFS 84.2%14 Her2 IHC 3+ORR=85.7%5 Her2 IHC 2+ORR=60.0%3 6.3%/ASCO ASCO 34/TROP2 ADC ESG401 ESG401 80%ECOG 1 63%4 2-10 94%11%63%60%20 mg/kg DLT MTD TRAEs 80%69%66%54%51%46%2 TRAEs 29%31%3 33 EE 12 PR 4 24 PR 16 mg/kg 3 IRD TNBC ORR 36%4/11 DCR 64%7/11 HR+/HER2-BC ORR 62%8/13 DCR 77%10/13 Regimen A Regimen B8mg/kg 12mg/kg 16mg/kg 20mg/kg 12mg/kg 14mg/kg 16mg/kg Totaln=3 n=3 n=5 n=5 n=5 n=6 n=6 n=33PR.n 0 0 2 2 3 1 4 12SD,n 1 0 1 1 1 4 1 9PD.n 2 3 2 2 1 1 1 12 ASCO ASCO 35I BB-1701/HER2 26 13 PR 11 SD BOR 50.0%13/26 DCR 92.3%24/26 17 12 PR 5 SD BOR 70.5%12/17 DCR 100%17/17 20%TRAEs 3 TRAE 10%4 9 BB-1701 2.6 mg/kg HER2 BB-1701 ASCO ASCO 36 DB-1303DB-1303/DB-1303/HER2 HER2 2023 1 13 85 DB-1303 7 32.9%HER2 ADC DB-1303 63.0 68 80.0%TEAEs 3 TEAEs 74 87.1%18 21.2%DB-1303 ADC Cmax AUC 6.0-8.0 mg/kg 6-7 52 RECIST 1.1 23 44.2%DB-1303/HER2 HER2 DB-1303 DCR 88.5%HER2 HER2 DCR 96.2%84.6%ASCO ASCO 37 HER2 ADC CBP-1018(-)1 14(1 0.03 mg/kg,3 0.06,0.08,0.10 mg/kg,4 0.12 mg/kg)(DLT)12(mCRPC)1 1 9(64.3%)(TRAEs)3(35.7%)(28.6%)(14.3%)GGT(14.3%)(14.3%)10 mCRPC 3 DLs 0.08 0.10 0.12mg/kg(SD),4 DLs 0.06 0.10 0.12mg/kg(non-PD),3 0.06 0.08 mg/kg(PD)0.10 mg/kg 3(PSA)(PFS)7.2(95%CI,1.7-9.3)mCRPC PFS CBP-1018 MMAE(PK profile)t1/2z 0.54 1.15 h 40.28 57.27 h CBP-1018 DLT DLs 0.03-0.12 mg/kg Q2W DLs 0.08-0.12 mg/kg SD mCRPC RP2D 38 4 ASCO ASCO 39/Carvykti ASCO LEGEND-24 I 0.51 106 CAR-positive T cells/kg65.4moORR=87.8%,CR=73.0%,DOR=23 mo,mPFS=18 mo,Mos=55.8 mo CARTITUDE-14 Ib/II 33.4moORR=98%,CR=83%,mPFS=34.9,mOS NR,36 mo OS rate=62.9%6 5 Carvykti CARTITUDE-42-4 III CARTITUDE-4 ASCO 1-3 3 LEGEND-2 CarvyktiCARTITUDE-1 In8bio Inc ASCO ASCO 40In8bio Inc T-()T(TMZ)(GBM)INB-200 15(53%;69;80%IDH,66.7%MGMT)8(C1 3 C2 4 C3 1)(DLT)(CRS)(ICANS)(AE)1/2 TMZ 1 UTI 3 3 C1(PFS)8.3 11.9 7.4(OS)15.6 17.7 9.6 C2 4 3 DLT;2 18.9 14.8 1/3 8.7 C3 DLT 6 5 CRCT T PFS In8bio Inc ASCO ASCO 41TROPiCS-02(SG)/HER2(HR+/HER2-)(mBC)(OS)543 SG(n=272)TPC(n=271)437 OS(12.75)SG TPC 47(8.7%)(22 8.1%25 9.2%)SG OS TPC(median 14.5 vs 11.2 mo;HR,0.79 95%CI,0.65-0.95;nominal P=0.01)12 SG TPC OS(95%CI)60.9%(54.8-66.4)47.1%(41.0-53.0)18 39.2%(33.4-45.0)31.7%(26.2-37.4)24 25.6%(20.4-31.1)21.1%(16.3-26.3)92%(IHC)HER2(HER2 IHC0,n=217;HER2-low,n=283)HER2 IHC0(median,13.6 vs 10.8 mo;HR,0.86 95%CI,0.63-1.13)HER2-low(median,15.4 vs 11.5 mo,HR,0.74 95%CI,0.57-0.97)SG OS TPC TROPiCS-02 OS SG CT HR+/HER2-mBC OS HER2 SG In8bio Inc T ASCO ASCO 42 CART BCMA/CD19 CAR-T GC012F/(RRMM)I 29 93.1%(27/29)82.8%(24/29)89.7%(26/29)(29/29)(10-4-10-6)MRD 24/29(82.8%)MRD-sCR(Kaplan-Meier)(DOR)37.0(95%CI,11.0-NR)(PFS)38.0(95%CI,11.8-NR)(CRS)25(86.2%)2(n=23,79.3%)2(6.9%)3 ICANS(ASBMT)CRS 3(1-8)DL1 DL3(PK)410(:51-1183)6 23(79.3%)16(55.2%)GC012F 80%(8/10)sBCMA 4 100%(19/19)10 100%(29/29)30 60 GC012F RRMM MRD cd38,pi IMIDs GC012F RRMM GC012F 43 5 Niraparib ASCO 44 RAS WT II RAS CBR/ORR PFS OS DoR CBR 83.3%CR 0PR 6SD 14ORR 25%mPFS 5.6mos 95%CI 3.7 6.9 mOS 20.9mos(95%CI:9.2,NR).AEs 58.4%20.8%16.7%4.2%2 TRAEs G3;12.5%G3 4.2%4-5 TRAE+PD-1 GBM ASCO 45 TTFields Optune+TMZ 2 PFS TTFields TMZ OS PBMC 26 60.5 14 54%19 73%MGMT 3 11.5%IDH TTF+PD-1+TMZ TTF+TMZ PFS 12.0 5.8 HR=0.466;95%CI:0.234-0.936;Log Rank P=0.007)12 PFS 50.0%28.2%P=0.058 OS 24.8 14.7 HR=0.388;95%CI:0.194-0.775;P=0.0392 OS 52.4%12.0%P=0.004PR/CR 40%6/15)4(15%)3(11.5%),2(7.7%)+PD-1 GBM ASCO 46 TTFields Optune+TMZ 2 PFS TTFields TMZ OS PBMC 26 60.5 14 54%19 73%MGMT 3 11.5%IDH TTF+PD-1+TMZ TTF+TMZ PFS 12.0 5.8 HR=0.466;95%CI:0.234-0.936;Log Rank P=0.007)12 PFS 50.0%28.2%P=0.058 OS 24.8 14.7 HR=0.388;95%CI:0.194-0.775;P=0.0392 OS 52.4%12.0%P=0.004PR/CR 40%6/15)4(15%)3(11.5%),2(7.7%)ROS1 TKI ASCO 47 ROS1+NSCLC CNS mets ROS1+NSCLC 4 ROS1 TKI 1 ROS1 TKI 1 ROS1 TKI 1 2 ROS1 TKI n=711 TKI and no chemon=561 TKI and 1 chemon=262 TKIs and no chemon=18Median follow-up,mo 18.1 15.5 21.3 14.1Pts with CNS mets,n(%)18(25)24(43)10(38)8(44)cORR,%95%CI8965-993316-554012-74130.3-536-mo DOR 95%CI100100-1006329-96501-99100100-10012-mo DOR95%CIa9379-100-Pts without CNS mets,n(%)53(75)32(57)16(62)10(56)cORR,%95%CI7662-864124-594420-704012-746-mo DOR95%CI8777-989276-1007138-100501-9912-mo DOR95%CIa8472-96-118 ROS1+NSCLC n=178 mets pts 57%/63%42%/53%32%/34%27%/12%17%/22%14%/10%STS ASCO 48 II 14-70 STS)300 mg q.d.21 12 PFS ORR DCR OS 2022 12 30 19 3 3 2 7(15 TEAEs 1-2 80%73%53%47%47%3-4 TEAE 4 PFR12 60%9 CR 1 ORR:6.7%)SD 11 DCR:80%)6.97 95%CI:5.28-8.65 PFS 5.7 95%CI:1.07-10.30 Grade=3 AE 27.8%NSCLC ASCO 49 NSCLC 1b/2 1 NSCLC 2 1b 9 3 250mg 2 DLT(1 3 1 3 6 200mg 1 DLT 3 200mg 60 mg/m2 2 11 AE 33.3%41.7%25%33.3%3 16.7%33.3%16.7%unexpected TRAEs ORR 27.2%(3/11)DCR 100%PFS 5.8 95%CI:2.1-9.4 FRESCO-2 ASCO 50 FRESCO-2 OS F:Fruquintinib P:Placebo VEGF EGFR TAS-102 F()P()HR;95%CI F()P()HR;95%CIITT population(461,230)7.4 4.80.662;0.549-0.880Anti-VEGF(445,221)7.4 4.90.683;0.565-0.827(125,64)7.6 5.20.714;0.488-1.043Anti-EGFR(180,88)7.4 4.40.689;0.507-0.9364 prior LOT,(122,59)7.4 4.70.661;0.454-0.963TAS-102(240,121)7.7 5.10.723;0.557-0.9385 prior LOT,(93,47)8.0 3.40.310;0.199-0.483R(40,18)10.2 8.20.772;0.379-1.573(121,60)6.7 5.20.818;0.566-1.183TAS-102&R(181,91)6.8 4.40.600;0.447-0.805prior lines of tx(LOT)ASCO 51 2 53mg D1-21 Q4w Q3w 8 PD PD PFS ORR DCR DOR OS 2023 2 10 37 31 11 29.7%KRAS 16 43.2%VEGF 20 54.1%11 29.7%6 23(74.2%)ORR 15(48.4%)2/3 AEs 3/4 21.6%10.8%5.4%2.7%ASCO 52 II BTC PFS ORR DCR OS 20 9 45.0%57.5 36-78 18 ICC 1 ECC 1 GBC 6 30%5 25%PFS 4.6 95%CI:2.1-7.1 ORR 5.6%DCR 66.7%1-2 TRAEs 83.3%1-2 66.6%61.1%44.4%38.9%ASCO ASCO 53 CDK4/6 BPI-16350 HR+/HER2-(MBC)CDK
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