Thaum Lub Tsib Hlis 29, Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo rau HER2-targeted antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) rau kev lag luam. Nws yog qhia tias yog ib qho kev kho mob monotherapy rau kev kho mob rau cov neeg laus uas muaj mob qog nqaij hlav hauv lub ntsws uas tsis tuaj yeem phais tau lossis kis mus rau lwm qhov (NSCLC) uas muaj HER2 (ERBB2) mutations thiab tau txais tsawg kawg ib qho kev kho mob systemic ua ntej. Qhov no yog thawj zaug uas Tuam Tshoj tsim ADC pom zoo rau cov neeg mob uas muaj HER2-mutated NSCLC, muab kev xaiv kho mob tshiab rau cov neeg mob no.
Qhov kev pom zoo yog raws li kev tshawb fawb tseem ceeb ntawm HORIZON-Lung, uas coj los ntawm Xibfwb Lu Shun los ntawm Shanghai Chest Hospital.
Kev tshawb fawb HORIZON-Lung yog ib qho kev sim tshuaj ntau lub chaw, qhib daim ntawv lo, Theem I/II uas coj los ntawm pab pawg neeg ntawm Xibfwb Lu Shun ntawm Shanghai Chest Hospital. Theem I lub hom phiaj yog txiav txim siab qhov koob tshuaj siab tshaj plaws (MTD) ntawm trastuzumab rezetecan thiab ntsuas nws qhov ua tau zoo thiab kev nyab xeeb thawj zaug rau cov neeg mob uas muaj HER2-mutated NSCLC. Kev tsim qauv kev tshawb fawb suav nrog ob qho tib si theem nce koob tshuaj thiab theem nthuav koob tshuaj. Hauv Theem I, trastuzumab rezetecan tau ua pov thawj txog kev ua haujlwm tiv thaiv qog nqaij hlav thawj zaug thiab muaj kev nyab xeeb zoo. Kev tshawb fawb Theem II tau tsim los ntsuas ntxiv txog qhov ua tau zoo thiab kev nyab xeeb ntawm trastuzumab rezetecan rau cov neeg mob uas muaj HER2-mutated NSCLC.
Tag nrho muaj 94 tus neeg mob tau raug sau npe rau hauv txoj kev tshawb fawb no. Cov txiaj ntsig tau qhia tias qhov kev teb sai sai (ORR), raws li Pawg Neeg Saib Xyuas Kev Ywj Pheej (IRC) tau soj ntsuam, yog 74.5%, nrog rau qhov kev tswj kab mob (DCR) ntawm 98.9%. Lub sijhawm teb nruab nrab (DoR) yog 9.8 lub hlis. Kev tshuaj xyuas pawg me me qhia tau hais tias qhov ua tau zoo ntawm trastuzumab rezetecan yog sib xws thoob plaws ntau pawg neeg mob, tsis hais txog kev kho mob anti-HER2 tyrosine kinase inhibitor (TKI) yav dhau los lossis muaj cov qog nqaij hlav metastases hauv lub hlwb.
Qhov kev muaj sia nyob tsis muaj kev nce qib (PFS) uas IRC soj ntsuam tau qhia tias muaj PFS nruab nrab ntawm 11.5 lub hlis, nrog rau tus nqi PFS 12 lub hlis ntawm 48.6%. Tus kws tshawb nrhiav soj ntsuam (INV) PFS yog 12.5 lub hlis, nrog rau tus nqi PFS 12 lub hlis ntawm 51.4%.
Cov ntaub ntawv txog kev muaj sia nyob tag nrho (OS) tseem tsis tau tiav, nrog rau qhov nruab nrab ntawm OS tseem tsis tau txog thiab tus nqi OS 12 lub hlis ntawm 88.2%.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Lub Rau Hli-04-2025