Celcuity Tshaj Tawm VIKTORIA-1 Hloov Tshiab: Gedatolisib Triplet Median PFS ntawm 21.5 Lub Hlis rau Cov Neeg Mob Cancer Mis Tsis Muaj Metastases Siab
MINNEAPOLIS — Celcuity Inc. (Nasdaq: CELC) thaum Lub Kaum Hli Ntuj hnub tim 24 tau nthuav tawm cov kev tshuaj xyuas tshiab ntawm Pawg Neeg me los ntawm Kev Kawm 2 ntawm Theem 3 VIKTORIA-1 kev sim ntawm European Society for Medical Oncology (ESMO) Congress 2026. Hauv cov neeg mob uas muaj mob qog noj ntshav hauv lub mis HR-positive, HER2-negative uas muaj kev hloov pauv PIK3CA uas tsis muaj kev kis mus rau lub siab, gedatolisib triplet (gedatolisib ntxiv rau fulvestrant thiab palbociclib) tau tsim cov neeg muaj sia nyob nruab nrab ntawm 21.5 lub hlis, piv rau 9.1 lub hlis rau alpelisib ntxiv rau fulvestrant, qhov piv txwv txaus ntshai ntawm 0.46 (p = 0.0016).
Cov ntaub ntawv tau nthuav tawm los ntawm Dr. Barbara Pistilli, tus thawj coj ntawm Chav Kho Mob Cancer Mis ntawm Gustave Roussy, hauv kev nthuav qhia sai sai (LBA 16). Ntawm cov neeg mob uas muaj mob qog nqaij hlav metastases, qhov nruab nrab ntawm kev ciaj sia tsis muaj kev nce qib yog 9.1 lub hlis ntawm triplet piv rau 4.6 lub hlis ntawm kev tswj hwm (kev pheej hmoo piv 0.47, p <0.0001); ntawm cov neeg mob uas muaj visceral metastases nws yog 9.8 piv rau 5.6 lub hlis (kev pheej hmoo piv 0.52). Hauv cov neeg mob uas tau soj ntsuam hauv PIK3CA-mutant cohort, triplet tus nqi teb yog 59 feem pua nrog lub sijhawm nruab nrab ntawm kev teb ntawm 19.4 lub hlis, piv rau 33 feem pua thiab 7.5 lub hlis rau kev tswj hwm.
Txog kev nyab xeeb, kev tsum tsis txhob siv gedatolisib vim muaj cov teeb meem tshwm sim los ntawm kev kho mob hauv cov neeg mob uas muaj kev hloov pauv yog 5 feem pua rau cov tshuaj triplet thiab 4 feem pua rau cov tshuaj doublet, piv rau 19 feem pua rau alpelisib. Lub tuam txhab tau hais tias mob stomatitis qib 3 nrog gedatolisib yog ib ntus xwb, poob qis dua 3 feem pua los ntawm lub voj voog kho mob thib ob, thiab kev tsum tsis txhob siv vim mob stomatitis yog 1 feem pua thiab 0 feem pua rau cov tshuaj triplet thiab doublet.
"Cov ntaub ntawv ntxiv los ntawm Kev Kawm 2 ntawm VIKTORIA-1 qhia tau tias muaj txiaj ntsig zoo thiab tseem ceeb rau cov pab pawg tseem ceeb ntawm cov neeg mob qog noj ntshav hauv lub mis uas tau kho nrog gedatolisib regimens," Igor Gorbachevsky, tus thawj coj kho mob ntawm Celcuity tau hais, thiab tau hais tias cov neeg mob uas tsis muaj qog nqaij hlav metastases sawv cev rau kwv yees li 60 txog 70 feem pua ntawm tag nrho cov neeg mob uas tau kho hauv qhov chaw no. Nws tau hais tias lub sijhawm nruab nrab ntawm kev teb ntawm triplet ntau dua 19 lub hlis hauv ob pawg VIKTORIA-1, raws li lub tuam txhab paub, yog qhov ntev tshaj plaws uas tau tshaj tawm hauv kev tshuaj xyuas thawj zaug ntawm Kev sim theem 3 hauv kab thib ob HR + / HER2- mob qog noj ntshav hauv lub mis.
Gedatolisib, muag raws li REVTORPYK, yog ib qho tshuaj pan-PI3K thiab mTORC1/2 inhibitor uas tau pom zoo los ntawm US Food and Drug Administration (FDA) rau cov neeg mob uas tsis pom muaj PIK3CA mutation, tom qab kev nce qib ntawm lossis tom qab kev kho mob endocrine hauv qhov chaw metastatic; cov txiaj ntsig tshiab cuam tshuam txog PIK3CA-mutant cohort sib cais. HR+/HER2- yog hom mob qog noj ntshav mis feem ntau, suav txog li 70 feem pua ntawm cov neeg mob. Celcuity, lub hauv paus chaw haujlwm hauv Minneapolis, kuj tseem tab tom khiav qhov kev sim theem 3 VIKTORIA-2 ntawm gedatolisib regimens ua thawj kab kev kho mob rau cov kab mob siab heev.
Qhov chaw: GSM · Tebchaws Meskas (Qhov kev tshaj tawm lus Askiv · Qhov kev tshaj tawm lus Suav qub)
Duab: 图：实验室研究人员进行样本处理（资料图）。照片：美国疾控中心（CDC），公共领域，经 Wikimedia Commons。 / Photo: A researcher at work in a laboratory (file photo). Photo by the U.S. Centers for Disease Control and Prevention, public domain, via Wikimedia Commons.
