ROS1 inhibitor DOVBLERON ® (Taletrectinib Adipate Capsule) Tau Pom Zoo Rau Kev Lag Luam Los Ntawm Tuam Tshoj National Medical Products Administration

Thaum Lub Kaum Ob Hlis 20, 2024, Tuam Tshoj Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo Daim Ntawv Thov Tshuaj Tshiab (NDA) ntawm DOVBLERON ® (taletrectinib adipate capsule), uas yog tiam tom ntej ROS1 tyrosine kinase inhibitor (TKI), rau kev kho mob rau cov neeg laus uas muaj mob qog nqaij hlav hauv lub ntsws ROS1-positive non-small cell (NSCLC) uas tau kho nrog ROS1 TKIs yav dhau los.

Kev pom zoo yog raws li cov txiaj ntsig zoo los ntawm qhov kev sim theem 2 TRUST-I tseem ceeb (NCT04395677), uas yog kev sim ntau lub chaw, qhib-daim ntawv lo, ib sab caj npab uas tau soj ntsuam taletrectinib hauv cov neeg mob Suav uas muaj NSCLC ROS1-zoo siab heev. Cov kev tshawb pom, uas tau nthuav tawm ntawm 2024 American Society of Clinical Oncology (ASCO) Lub Rooj Sib Tham Txhua Xyoo thiab luam tawm hauv Journal of Clinical Oncology (JCO), tau qhia txog lub peev xwm ntawm DOVBLERON® los daws cov kev xav tau tsis tau txais, tshwj xeeb tshaj yog rau cov neeg mob uas muaj kev xaiv kho mob tsawg tom qab kev kho mob nrog cov kev kho mob ROS1 yav dhau los.

Txij li thaum Lub Kaum Ib Hlis 29, 2023, muaj 173 tus neeg mob Suav (106 TKI naїve; 67 crizotinib-pretreated) tau txais taletrectinib. Ntawm 106 tus neeg mob TKI-naїve, IRC-assessed cORR yog 90.6% (95% CI, 83.33 txog 95.38) nrog plaub (3.8%) cov neeg mob ua tiav CR thiab 92 (86.8%) ua tiav PR. DCR yog 95.3% (95% CI, 89.33 txog 98.45), thiab qhov nruab nrab TTR yog 1.4 lub hlis (95% CI, 1.38 txog 1.41). Nrog rau kev saib xyuas nruab nrab ntawm 22.1 lub hlis thiab 23.5 lub hlis, tsis muaj qhov nruab nrab DOR lossis nruab nrab PFS tau mus txog; 24-hli DOR thiab PFS yog 78.6% (95% CI, 66.86 txog 86.56) thiab 70.5% (95% CI, 59.17 txog 79.16), raws li.

Ntawm 66 tus neeg mob uas tau kho nrog crizotinib, IRC-assessed cORR yog 51.5% (95% CI, 38.88 txog 64.01) nrog rau 34 (51.5%) cov neeg mob tau txais PR. DCR yog 83.3% (95% CI, 72.13 txog 91.38), thiab qhov nruab nrab TTR yog 1.4 lub hlis (95% CI, 1.38 txog 1.41). Nrog 8.4 lub hlis thiab 9.7 lub hlis ntawm kev saib xyuas, qhov nruab nrab DOR yog 10.6 lub hlis (95% CI, 6.31 txog tsis tau mus txog [NR]), thiab qhov nruab nrab PFS yog 7.6 lub hlis (95% CI, 5.52 txog 11.96). Cov nqi DOR thiab PFS 9 lub hlis yog 69.8% (95% CI, 47.94 txog 83.84) thiab 47.4% (95% CI, 33.50 txog 60.02), raws li. Cov txiaj ntsig zoo sib xws tau pom thaum cov kws tshawb nrhiav soj ntsuam.

Txog DOVBLERON ® (Taletrectinib Adipate Capsule)

DOVBLERON ® yog ib qho ROS1 uas siv qhov ncauj, muaj zog, thiab ua haujlwm rau lub paj hlwb hauv nruab nrab, xaiv tau, tiam tom ntej.

tshuaj inhibitor tsim tshwj xeeb rau kev kho cov neeg mob uas muaj ROS1-positive NSCLC siab heev. Taletrectinib, cov khoom xyaw nquag hauv DOVBLERON ® tab tom raug soj ntsuam rau kev kho cov neeg mob uas muaj ROS1-positive NSCLC siab heev hauv ob txoj kev tshawb fawb theem 2 ib sab caj npab: TRUST-I (NCT04395677) hauv Suav teb, thiab TRUST-II (NCT04919811), kev tshawb fawb thoob ntiaj teb.

Mob qog noj ntshav hauv lub ntsws tseem muaj ib qho ntawm cov neeg mob thiab cov neeg tuag coob tshaj plaws hauv ntiaj teb, nrog rau NSCLC suav txog li 85% ntawm txhua tus neeg mob. Hauv Suav teb, kwv yees li ntawm 2.6% ntawm cov neeg mob uas muaj NSCLC yog ROS1-positive. Ntxiv mus, kev kis mus rau lub hlwb yog ib qho teeb meem uas tshwm sim ntau, cuam tshuam txog li 35% ntawm cov neeg mob tshiab uas tau kuaj pom tias muaj NSCLC ROS1-positive, thiab nce mus txog li 55% ntawm cov neeg mob uas mob qog noj ntshav tau nce qib tom qab kev kho mob thawj zaug. Ntxiv mus, cov neeg mob uas tau kho nrog ROS1 TKIs uas tau pom zoo feem ntau tsim cov kev hloov pauv tiv thaiv rau cov kev kho mob no, uas sawv cev rau qhov kev txwv loj rau cov neeg mob hauv lub sijhawm teb. Kev pom zoo ntawm DOVBLERON® muab kev xaiv kho mob tshiab thiab zoo rau cov neeg mob uas tsis teb rau cov kev kho mob uas tau pom zoo yav dhau los.

Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.

Xov Tooj: 4008803716

Email:myimmnet@163.com

Cov ntaub ntawv siv los ua piv txwv

1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html

2.Xov Xwm Tshaj Tawm (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