Disemba 20, 2024, I-National Medical Products Administration (NMPA) yaseShayina ivumile i-New Drug Application (NDA) ye-DOVBLERON ® (taletrectinib adipate capsule), i-ROS1 tyrosine kinase inhibitor (TKI) yesizukulwane esilandelayo, yokwelapha iziguli ezindala ezinomdlavuza wamaphaphu we-non-small cell ongenayo i-ROS1 (NSCLC) othuthukisiwe endaweni noma osakazeke kakhulu, oke welashwa nge-ROS1 TKIs ngaphambilini.
Ukuvunyelwa kusekelwe emiphumeleni emihle evela esivivinyweni esibalulekile se-Trust-I seSigaba 2 (NCT04395677), isivivinyo esibanzi, esivulekile, esingalodwa esihlole i-taletrectinib ezigulini zaseShayina ezine-NSCLC ethuthukisiwe ye-ROS1. Okutholakele, okwethulwe eMhlanganweni Waminyaka Yonke we-American Society of Clinical Oncology (ASCO) ka-2024 futhi kwanyatheliswa kuyi-Journal of Clinical Oncology (JCO), kubonise amandla e-DOVBLERON® okubhekana nezidingo ezingakahlangatshezwani, ikakhulukazi ezigulini ezinezinketho zokwelapha ezilinganiselwe ngemva kokwelashwa ngemithi yokwelapha eqondiswe ku-ROS1 ngaphambilini.
Kusukela ngoNovemba 29, 2023, iziguli zaseShayina eziyi-173 (eziyi-106 TKI naїve; ezingama-67 crizotinib-pretreated) zithole i-taletrectinib. Phakathi kweziguli eziyi-106 TKI-naїve, i-IRC-assessed cORR yayingu-90.6% (95% CI, 83.33 kuya ku-95.38) kanye neziguli ezine (3.8%) ezifinyelele i-CR kanye neziyi-92 (86.8%) ezifinyelele i-PR. I-DCR yayingu-95.3% (95% CI, 89.33 kuya ku-98.45), kanti i-TTR ephakathi yayiyizinyanga eziyi-1.4 (95% CI, 1.38 kuya ku-1.41). Ngokulandelwa okuphakathi kwezinyanga ezingama-22.1 nezinyanga ezingama-23.5, akukho DOR ephakathi noma i-PFS ephakathi okufinyelelwe; i-DOR kanye ne-PFS yezinyanga ezingu-24 bekuyi-78.6% (95% CI, 66.86 kuya ku-86.56) kanye ne-70.5% (95% CI, 59.17 kuya ku-79.16), ngokulandelana.
Phakathi kweziguli ezingu-66 ezelashwe kusengaphambili nge-crizotinib, i-cORR ehlolwe yi-IRC yayingu-51.5% (95% CI, 38.88 kuya ku-64.01) kanti iziguli ezingu-34 (51.5%) zithole i-PR . I-DCR yayingu-83.3% (95% CI, 72.13 kuya ku-91.38), kanti i-TTR ephakathi yayiyizinyanga ezingu-1.4 (95% CI, 1.38 kuya ku-1.41). Ngezinyanga ezingu-8.4 nezinyanga ezingu-9.7 zokulandelela, i-DOR ephakathi yayiyizinyanga ezingu-10.6 (95% CI, 6.31 kuya ku-[NR]), kanti i-PFS ephakathi yayiyizinyanga ezingu-7.6 (95% CI, 5.52 kuya ku-11.96). Amanani e-DOR kanye ne-PFS ezinyanga ezingu-9 ayengu-69.8% (95% CI, 47.94 kuya ku-83.84) kanye no-47.4% (95% CI, 33.50 kuya ku-60.02), ngokulandelana. Imiphumela efanayo ibonwe lapho ihlolwa ngabaphenyi.
Mayelana ne-DOVBLERON ® (Taletrectinib Adipate Capsule)
I-DOVBLERON ® iyi-ROS1 yesizukulwane esilandelayo esetshenziswa ngomlomo, enamandla, esebenza kahle ohlelweni lwezinzwa oluphakathi, ekhethayo
inhibitor eyenzelwe ngqo ukwelashwa kweziguli ezine-NSCLC ethuthukisiwe ye-ROS1-positive. I-Taletrectinib, isithako esisebenzayo ku-DOVBLERON ® sihlolwa ukwelashwa kweziguli ezine-NSCLC ethuthukisiwe ye-ROS1 ezifundweni ezimbili ezibalulekile zesigaba sesi-2: i-TRUST-I (NCT04395677) eShayina, kanye ne-TRUST-II (NCT04919811), ucwaningo lomhlaba wonke.
Umdlavuza wamaphaphu uyaqhubeka nokuba nesinye sezifo eziphezulu kakhulu emhlabeni kanye namazinga okufa, kanti i-NSCLC ibalwa cishe ku-85% wazo zonke izimo. E-China, kulinganiselwa ukuthi cishe u-2.6% weziguli eziphila ne-NSCLC zine-ROS1-positive. Ngaphezu kwalokho, i-metastases yobuchopho iyinselele evamile, ethinta kufika ku-35% weziguli ezisanda kutholakala zine-NSCLC ene-metastatic ROS1-positive, futhi ikhula ibe ngu-55% weziguli ezinomdlavuza oqhubekele phambili ngemuva kokwelashwa kokuqala. Ngaphezu kwalokho, iziguli ezelashwe nge-ROS1 TKIs ezivunyiwe zivame ukuthuthukisa izinguquko zokumelana nalezi zindlela zokwelapha, okumelela umkhawulo omkhulu weziguli maqondana nobude besikhathi sokuphendula. Ukuvunyelwa kwe-DOVBLERON® kunikeza inketho yokwelapha entsha nephumelelayo yeziguli ezingasaphenduli ekwelashweni okuvunyiwe ngaphambilini.
Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.
Inombolo yocingo: 4008803716
I-imeyili：myimmnet@163.com
Izinkomba
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Isitatimende Sabezindaba (innoventbio.com)
3.https://ascopubs.org/doi/10.1200/JCO.24.00731?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Isikhathi sokuthunyelwe: Disemba-27-2024