La 20 Tšitoe 2024, Tsamaiso ea Naha ea Lihlahisoa tsa Bongaka ea Chaena (NMPA) e amohetse Kopo e Ncha ea Meriana (NDA) ea DOVBLERON ® (taletrectinib adipate capsule), e leng ROS1 tyrosine kinase inhibitor (TKI) ea moloko o latelang, bakeng sa kalafo ea bakuli ba baholo ba nang le kankere ea matšoafo ea lisele tse nyenyane tsa ROS1 e tsoetseng pele kapa e nang le metastatic ba kileng ba phekoloa ka ROS1 TKIs pele.
Kamohelo ena e ipapisitse le liphetho tse ntle tse tsoang tekong ea bohlokoa ea Mokhahlelo oa 2 TRUST-I (NCT04395677), teko ea libaka tse ngata, e bulehileng, e nang le letsoho le le leng e ileng ea hlahloba taletrectinib ho bakuli ba Machaena ba nang le NSCLC e tsoetseng pele ea ROS1. Liphuputso, tse hlahisitsoeng Sebokeng sa Selemo le Selemo sa Mokhatlo oa Amerika oa Oncology ea Bongaka (ASCO) sa 2024 mme tsa hatisoa ho Journal of Clinical Oncology (JCO), li bontšitse bokhoni ba DOVBLERON® ba ho sebetsana le litlhoko tse sa fihlellehang, haholo-holo ho bakuli ba nang le likhetho tse fokolang tsa kalafo kamora kalafo ka mekhoa ea phekolo e reretsoeng ROS1 pele.
Ho tloha ka la 29 Pulungoana, 2023, bakuli ba 173 ba Chaena (106 TKI naїve; 67 crizotinib-pretreated) ba ile ba fumana taletrectinib. Har'a bakuli ba 106 ba TKI-naїve, cORR e lekotsoeng ke IRC e ne e le 90.6% (95% CI, 83.33 ho isa ho 95.38) ka bakuli ba bane (3.8%) ba fihletseng CR le 92 (86.8%) ba fihletseng PR. DCR e ne e le 95.3% (95% CI, 89.33 ho isa ho 98.45), 'me TTR e mahareng e ne e le likhoeli tse 1.4 (95% CI, 1.38 ho isa ho 1.41). Ka tlhahlobo e mahareng ea likhoeli tse 22.1 le likhoeli tse 23.5, ha ho DOR e mahareng kapa PFS e mahareng e ileng ea fihlelloa; DOR le PFS tsa likhoeli tse 24 e ne e le 78.6% (95% CI, 66.86 ho isa ho 86.56) le 70.5% (95% CI, 59.17 ho isa ho 79.16), ka ho latellana.
Har'a bakuli ba 66 ba ileng ba phekoloa pele ho crizotinib, cORR e lekotsoeng ke IRC e ne e le 51.5% (95% CI, 38.88 ho isa ho 64.01) ka bakuli ba 34 (51.5%) ba fihletseng PR . DCR e ne e le 83.3% (95% CI, 72.13 ho isa ho 91.38), 'me TTR e mahareng e ne e le likhoeli tse 1.4 (95% CI, 1.38 ho isa ho 1.41). Ka likhoeli tse 8.4 le likhoeli tse 9.7 tsa tlhahlobo, DOR e mahareng e ne e le likhoeli tse 10.6 (95% CI, 6.31 ho isa ho tse sa fihlelloang [NR]), 'me PFS e mahareng e ne e le likhoeli tse 7.6 (95% CI, 5.52 ho isa ho 11.96). Litefiso tsa DOR le PFS tsa likhoeli tse 9 e ne e le 69.8% (95% CI, 47.94 ho isa ho 83.84) le 47.4% (95% CI, 33.50 ho isa ho 60.02), ka ho latellana. Liphetho tse tšoanang li bonoe ha li hlahlojoa ke bafuputsi.
Mabapi le DOVBLERON ® (Taletrectinib Adipate Capsule)
DOVBLERON ® ke ROS1 ea moloko o latelang e sebelisoang ka molomo, e matla, e sebetsang tsamaisong ea methapo e bohareng, e khethang,
inhibitor e etselitsoeng ka ho khetheha kalafo ea bakuli ba nang le NSCLC e tsoetseng pele ea ROS1. Taletrectinib, motsoako o sebetsang ho DOVBLERON ® o ntse o hlahlojoa bakeng sa kalafo ea bakuli ba nang le NSCLC e tsoetseng pele ea ROS1 lithutong tse peli tsa bohlokoa tsa Mokhahlelo oa 2: TRUST-I (NCT04395677) Chaena, le TRUST-II (NCT04919811), phuputso ea lefats'e.
Kankere ea matšoafo e ntse e tsoela pele ho ba le e 'ngoe ea liketsahalo tse phahameng ka ho fetisisa lefatšeng ka bophara le sekhahla sa lefu, 'me NSCLC e ikarabella bakeng sa hoo e ka bang 85% ea linyeoe tsohle. Chaena, ho hakanngoa hore hoo e ka bang 2.6% ea bakuli ba phelang le NSCLC ba na le ROS1-positive. Ho feta moo, metastases ea boko ke phephetso e tloaelehileng, e amang ho fihla ho 35% ea bakuli ba sa tsoa fumanoa ba na le NSCLC ea ROS1-positive e nang le metastatic, 'me e eketseha ho fihla ho 55% ea bakuli bao kankere ea bona e tsoetseng pele kamora kalafo ea pele. Ho phaella moo, bakuli ba phekoloang ka ROS1 TKIs tse amohetsoeng hangata ba ba le liphetoho tsa ho hanyetsa mekhoa ena ea phekolo, e leng se emelang moeli o moholo bakeng sa bakuli mabapi le nako ea karabelo. Kamohelo ea DOVBLERON® e fana ka khetho e ncha le e sebetsang ea kalafo bakeng sa bakuli ba seng ba sa arabele mekhoa ea phekolo e amohetsoeng pele.
Hona jwale, ho ntse ho na le diteko tse ngata tsa bongaka tsa mahlale a matjha a ho lwantsha kankere Chaena a batlang bakudi. Dipuisano mabapi le meriana le mahlale a matjha, o ka ikopanya le Lefapha la Matjhaba la Sepetlele sa Oncology sa Beijing Region South.
Nomoro ea mohala: 4008803716
Imeile：myimmnet@163.com
Litšupiso
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Phatlalatso ea Boralitaba (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
Nako ea poso: Tshitwe-27-2024