Ngomhla wama-20 kuDisemba, ngo-2024, i-National Medical Products Administration (NMPA) yaseTshayina ivumile isicelo esitsha seyeza (NDA) se-DOVBLERON ® (taletrectinib adipate capsule), i-ROS1 tyrosine kinase inhibitor (TKI) yesizukulwana esilandelayo, yokunyanga izigulane zabantu abadala abanomhlaza wemiphunga ongekho mncinci (NSCLC) ophucukileyo okanye osasazekileyo we-ROS1-positive) ongekho mncinci (NSCLC) abaye banyangwa ngaphambili nge-ROS1 TKIs.
Ukuvunywa kusekelwe kwiziphumo ezilungileyo ezivela kuvavanyo olubalulekileyo lweSigaba sesi-2 se-TRUST-I (NCT04395677), uvavanyo oluneendawo ezininzi, oluvulelekileyo, nolwengalo enye oluvavanye i-taletrectinib kwizigulane zaseTshayina ezine-NSCLC ephucukileyo ye-ROS1. Iziphumo, ezivezwe kwiNtlanganiso yoNyaka ye-2024 ye-American Society of Clinical Oncology (ASCO) kwaye zapapashwa kwiJournal of Clinical Oncology (JCO), zibonise amandla e-DOVBLERON® okujongana neemfuno ezingafezekiswanga, ngakumbi kwizigulane ezineendlela zonyango ezinqongopheleyo emva konyango olujoliswe kwi-ROS1 ngaphambili.
Ukususela nge-29 kaNovemba ngo-2023, izigulane zaseTshayina ezili-173 (106 TKI naїve; 67 crizotinib-pretreated) zafumana i-taletrectinib. Phakathi kwezigulane ezili-106 TKI-naїve, i-IRC-assessed cORR yayiyi-90.6% (95% CI, 83.33 ukuya kwi-95.38) kunye nezigulane ezine (3.8%) ezifumene i-CR kunye ne-92 (86.8%) ezifumene i-PR. I-DCR yayiyi-95.3% (95% CI, 89.33 ukuya kwi-98.45), kwaye i-TTR ephakathi yayiyi-1.4 yeenyanga (95% CI, 1.38 ukuya kwi-1.41). Ngokulandelelwa okuphakathi kweenyanga ezingama-22.1 kunye neenyanga ezingama-23.5, akukho DOR ephakathi okanye i-PFS ephakathi efikelelweyo; I-DOR kunye ne-PFS zeenyanga ezingama-24 beziyi-78.6% (95% CI, 66.86 ukuya kwi-86.56) kunye ne-70.5% (95% CI, 59.17 ukuya kwi-79.16), ngokwahlukeneyo.
Phakathi kwezigulane ezingama-66 eziphathwe kwangaphambili yi-crizotinib, i-IRC-assessed cORR yayiyi-51.5% (95% CI, 38.88 ukuya ku-64.01) kunye nezigulane ezingama-34 (51.5%) ezifumene i-PR . I-DCR yayiyi-83.3% (95% CI, 72.13 ukuya ku-91.38), kwaye i-TTR ephakathi yayiyi-1.4 yeenyanga (95% CI, 1.38 ukuya ku-1.41). Ngeenyanga eziyi-8.4 kunye neenyanga eziyi-9.7 zokulandelela, i-DOR ephakathi yayiyi-10.6 yeenyanga (95% CI, 6.31 ukuya ku-[NR]), kwaye i-PFS ephakathi yayiyi-7.6 yeenyanga (95% CI, 5.52 ukuya ku-11.96). Amanani e-DOR kunye ne-PFS eenyanga ezili-9 ebeyi-69.8% (95% CI, 47.94 ukuya ku-83.84) kunye ne-47.4% (95% CI, 33.50 ukuya ku-60.02), ngokwahlukeneyo. Iziphumo ezifanayo zibonwe xa kuvavanywa ngabaphandi.
Malunga neDOVBLERON ® (Taletrectinib Adipate Capsule)
I-DOVBLERON ® yi-ROS1 yesizukulwana esilandelayo, enamandla, esebenza kwinkqubo yemithambo-luvo ephakathi, ekhethayo nesetyenziswa ngomlomo.
inhibitor eyenzelwe ngokukodwa ukunyanga izigulane ezine-NSCLC ye-ROS1-positive ephucukileyo. I-Taletrectinib, isithako esisebenzayo kwi-DOVBLERON ® siyavavanywa ukunyanga izigulane ezine-NSCLC ye-ROS1-positive ephucukileyo kwizifundo ezimbini zeSigaba sesi-2 se-single-arm pivotal: i-TRUST-I (NCT04395677) eTshayina, kunye ne-TRUST-II (NCT04919811), uphando lwehlabathi.
Umhlaza wemiphunga uyaqhubeka nokuba yenye yezona ziganeko ziphezulu kwihlabathi liphela kunye namanani okufa, apho i-NSCLC imalunga ne-85% yazo zonke iimeko. E-China, kuqikelelwa ukuba malunga ne-2.6% yezigulana eziphila ne-NSCLC zine-ROS1-positive. Ngaphezu koko, i-metastases yobuchopho yingxaki eqhelekileyo, echaphazela ukuya kuthi ga kwi-35% yezigulana ezisandula ukufunyanwa zine-metastatic ROS1-positive NSCLC, kwaye inyuka iye kuthi ga kwi-55% yezigulana ezinomhlaza oqhubele phambili emva konyango lokuqala. Ukongeza, izigulana ezinyangwa nge-ROS1 TKIs ezivunyiweyo zihlala ziphuhlisa utshintsho lokuxhathisa kwezi ndlela zonyango, nto leyo emele umda omkhulu kwizigulana ngokwexesha lokuphendula. Ukuvunywa kwe-DOVBLERON® kubonelela ngokhetho olutsha nolusebenzayo lonyango kwizigulana ezingasaphenduliyo kunyango oluvunyiweyo ngaphambili.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
Inombolo yefowuni: 4008803716
I-imeyile：myimmnet@163.com
Iireferensi
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Isaziso seendaba (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
Ixesha leposi: Disemba-27-2024