Vebreltinib Yalandira Chilolezo Chokhazikika ku China cha MET-Amplified NSCLC

Pa June 30, mankhwala oletsa MET a Avistone omwe adapangidwa paokha, Vebreltinib, adalandira chilolezo chochokera ku National Medical Products Administration (NMPA) ku China kuti athandize odwala omwe ali ndi khansa ya m'mapapo yopanda maselo ang'onoang'ono (NSCLC) yomwe ili ndi MET amplification. Ichi ndi chizindikiro chachitatu chovomerezeka cha Vebreltinib ku China ndipo chithandizo choyamba padziko lonse lapansi chovomerezeka makamaka kwa odwala a MET-amplified NSCLC.

Kuvomerezedwa kwa Vebreltinib ku China kwa chizindikiro chatsopanochi—kuchiza odwala omwe ali ndi khansa ya m'mapapo yopanda maselo ang'onoang'ono (NSCLC) yomwe ili ndi MET amplification—kunachokera ku zotsatira zabwino kuchokera ku Gulu 2 ndi Gulu 3 la kafukufuku wa KUNPENG (NCT04258033).

Gulu lachiwiri linalembetsa makamaka odwala omwe adathandizidwa kale ndi NSCLC yowonjezeredwa ndi MET omwe adalephera kulandira chithandizo chokhazikika (kuphatikiza chemotherapy yochokera ku platinum), pomwe Gulu lachitatu makamaka lidaphatikizapo odwala omwe sanalandire chithandizo ndi NSCLC yowonjezeredwa ndi MET omwe adakana kulandira chemotherapy.

Odwala 86 omwe ali ndi NSCLC yapamwamba kapena yofalikira m'deralo adalembetsedwa m'magulu onse awiri (33 mu Gulu 2 ndi 53 mu Gulu 3). Zotsatira za kafukufukuyu zidawonetsa kuchuluka kwa mayankho ofunikira (ORR) kwa 48.8%, kuchuluka kwa matenda (DCR) kwa 77.9%, nthawi yapakati yoyankha (DoR) kwa miyezi 12.1, kupulumuka kosapitirira muyeso (PFS) kwa miyezi 7.4, ndi kupulumuka kosapitirira muyeso (OS) kwa miyezi 13.9.

Mu Gulu Lachiwiri (odwala 33 omwe adachiritsidwa kale), ORR inali 48.5%, DCR inali 78.8%, apakati DoR inali miyezi 11.0, apakati PFS inali miyezi 6.2, ndipo apakati OS inali miyezi 11.7.

Mu Gulu 3 (odwala 53 omwe sanalandire chithandizo), ORR inali 49.1%, DCR inali 77.4%, apakati DoR inali miyezi 12.1, apakati PFS inali miyezi 8.3, ndipo apakati OS inali miyezi 15.5.

Mu kafukufuku wa KUNPENG, odwala 21 omwe ali ndi matenda a ubongo oyambira adayesedwa ndi Independent Review Committee (IRC). Pakati pa awa, 10 adapeza mayankho otsimikizika a gawo (PR), zomwe zidapangitsa kuti ORR ikhale 47.6%, DCR ikhale 85.7%, ndi apakati DoR ikhale miyezi 11.0. Kuphatikiza apo, apakati PFS ndi OS anali miyezi 8.3 ndi miyezi 14.7 motsatana.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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