Kekemapa 20, 2024, ua ʻāpono ka National Medical Products Administration (NMPA) o Kina i kahi New Drug Application (NDA) o DOVBLERON ® (taletrectinib adipate capsule), kahi hanauna hou o ROS1 tyrosine kinase inhibitor (TKI), no ka mālama ʻana i nā poʻe maʻi makua me ka maʻi ʻaʻai māmā non-small cell ROS1-positive locally advanced a metastatic paha (NSCLC) i mālama mua ʻia me ROS1 TKIs.
Ua hoʻokumu ʻia ka ʻae ʻia ma nā hopena maikaʻi mai ka hoʻokolohua pivotal Phase 2 TRUST-I (NCT04395677), kahi hoʻokolohua multicenter, open-label, single-arm i loiloi i ka taletrectinib i nā maʻi Kina me ka ROS1-positive NSCLC holomua. ʻO nā ʻike, i hōʻike ʻia ma ka 2024 American Society of Clinical Oncology (ASCO) Annual Meeting a paʻi ʻia ma ka Journal of Clinical Oncology (JCO), ua hōʻike i ka hiki o DOVBLERON® ke hoʻoponopono i nā pono i hoʻokō ʻole ʻia, ʻoi aku hoʻi i nā maʻi me nā koho therapeutic palena ma hope o ka mālama ʻana me nā therapies ROS1-targeted mua.
Ma Nowemapa 29, 2023, ua loaʻa i nā maʻi Kina he 173 (106 TKI naїve; 67 crizotinib-pretreated) ka taletrectinib. Ma waena o nā maʻi TKI-naїve he 106, ʻo ka cORR i loiloi ʻia e IRC he 90.6% (95% CI, 83.33 a 95.38) me ʻehā (3.8%) mau maʻi i hoʻokō i ka CR a me 92 (86.8%) i hoʻokō i ka PR. ʻO ka DCR he 95.3% (95% CI, 89.33 a 98.45), a ʻo ka median TTR he 1.4 mahina (95% CI, 1.38 a 1.41). Me ka median follow-up o 22.1 mahina a me 23.5 mahina, ʻaʻole i hiki i ka median DOR a i ʻole ka median PFS; ʻo ka DOR a me ka PFS 24 mahina he 78.6% (95% CI, 66.86 a 86.56) a me 70.5% (95% CI, 59.17 a 79.16), kēlā me kēia.
Ma waena o 66 mau maʻi i mālama mua ʻia me crizotinib, ʻo ka cORR i loiloi ʻia e IRC he 51.5% (95% CI, 38.88 a 64.01) me 34 (51.5%) mau maʻi i hoʻokō i ka PR. ʻO ka DCR he 83.3% (95% CI, 72.13 a 91.38), a ʻo ka median TTR he 1.4 mahina (95% CI, 1.38 a 1.41). Me 8.4 mahina a me 9.7 mahina o ka hahai ʻana, ʻo ka median DOR he 10.6 mahina (95% CI, 6.31 a hiki ʻole i ka [NR]), a ʻo ka median PFS he 7.6 mahina (95% CI, 5.52 a 11.96). ʻO nā helu DOR a me PFS 9 mahina he 69.8% (95% CI, 47.94 a 83.84) a me 47.4% (95% CI, 33.50 a 60.02), kēlā me kēia. Ua ʻike ʻia nā hopena like i ka wā i loiloi ʻia ai e nā mea noiʻi.
E pili ana iā DOVBLERON ® (Taletrectinib Adipate Capsule)
He ROS1 waha, ikaika, hana i ka ʻōnaehana nerve waena, koho, hanauna hou ʻo DOVBLERON ®
mea hoʻopale i hoʻolālā kūikawā ʻia no ka mālama ʻana i nā maʻi me ka ROS1-positive NSCLC holomua. Ke loiloi ʻia nei ʻo Taletrectinib, ka mea hana nui i loko o DOVBLERON ® no ka mālama ʻana i nā maʻi me ka ROS1-positive NSCLC holomua i ʻelua mau haʻawina pivotal lima hoʻokahi Phase 2: TRUST-I (NCT04395677) ma Kina, a me TRUST-II (NCT04919811), kahi noiʻi honua.
ʻO ka maʻi kanesa māmā kekahi o nā hanana kiʻekiʻe loa o ka honua a me nā helu make, me ka NSCLC e helu ana ma kahi o 85% o nā hihia āpau. Ma Kina, ua manaʻo ʻia aia ma kahi o 2.6% o nā maʻi e noho ana me NSCLC he ROS1-positive. Eia kekahi, he pilikia maʻamau nā metastases o ka lolo, e pili ana i ka 35% o nā maʻi i ʻike hou ʻia me ka metastatic ROS1-positive NSCLC, a e piʻi ana a hiki i ka 55% o nā maʻi i holomua ka maʻi kanesa ma hope o ka mālama mua ʻana. Eia kekahi, hoʻomohala pinepine nā maʻi i mālama ʻia me nā ROS1 TKI i ʻae ʻia i nā mutations kū'ē i kēia mau lāʻau lapaʻau, e hōʻike ana i kahi palena nui no nā maʻi e pili ana i ka lōʻihi o ka pane. Hāʻawi ka ʻae ʻia o DOVBLERON® i kahi koho lapaʻau hou a maikaʻi no nā maʻi i pane ʻole i nā lāʻau lapaʻau i ʻae mua ʻia.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
Leka uila:myimmnet@163.com
Nā Kuhikuhi
1.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20241220172636101.html
2.Hoʻolaha Paʻi (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
Ka manawa hoʻouna: Dec-27-2024