Ua Tuuina Atu le Iloiloga Faamuamua i Saina mo le Trastuzumab Deruxtecan mo le Kanesa o le Gastric Maualuga HER2-Positive

I le aso 10 o Iuni, na faasilasila mai ai e le Nofoaga Autu mo Iloiloga o Fualaau Faasaina (CDE) a le Pulega o Oloa Faafoma’i a le Atunuu (NMPA) ua fautuaina e tuuina atu le faamuamua i le iloiloga o le Trastuzumab Deruxtecan (T-DXd, DS-8201a) mo le togafitia o gasegase matutua e maua i le HER2-positive gastric po o le gastroesophageal junction (GEJ) adenocarcinoma ua alualu i luma po o le metastatic ma ua uma ona mauaina le tasi togafitiga muamua.

I le suega Vaega II o le DESTINY-Gastric01, na faʻaleleia atili ai e le DS-8201 le fua faatatau o tali ma le soifua maloloina lautele i gasegase e iai le HER2-positive gastric adenocarcinoma (GC) poʻo le gastroesophageal junction (GEJ) adenocarcinoma. Na aofia ai i le suega le 125 gasegase na togafitia i le DS-8201, ma faʻaalia ai le fua faatatau o tali (ORR) e 51%, le umi o le tali (DOR) e 11.3 masina, ma le fua faatatau o le puleaina o faʻamaʻi (DCR) e 86%.

O le suʻesuʻega Vaega III a le DESTINY-Gastric04 na iloiloina ai le aoga ma le saogalemu o le Trastuzumab Deruxtecan (6.4 mg/kg) e faʻatusatusa i le ramucirumab faʻatasi ai ma le paclitaxel o se togafitiga lona lua mo gasegase e iai le HER2-positive unresetable ma/poʻo le metastatic gastric poʻo le GEJ adenocarcinoma. O faʻaiʻuga na faʻaalia ai, e oʻo atu i le aso 24 o Oketopa, 2024, o le vaega o le trastuzumab deruxtecan na faʻaalia ai se ola umi tele (OS) (14.7 masina vs. 11.4 masina, HR=0.70, P=0.0044) ma le ola e aunoa ma le alualu i luma (PFS) (6.7 masina vs. 5.6 masina). Sa maualuga atu foʻi le ORR (44.3% vs. 29.1%), faʻapea foʻi ma le DCR (91.9% vs. 75.9%).

O le Trastuzumab deruxtecan (sa ta'ua muamua o le DS-8201), o se antibody-drug conjugate e aofia ai se humanized anti-HER2 monoclonal antibody e feso'ota'i ma se topoisomerase I inhibitor payload e ala i se tetrapeptide-based cleavable linker, ua fa'amaonia mo le togafitia o gasegase e maua i le metastatic HER2-positive breast cancer. E le pei o le tele o isi togafitiga fa'amaonia HER2-targeted, e mafai fo'i e le trastuzumab deruxtecan ona fa'atatau lelei i sela o le tumo e fa'aalia ai le maualalo o le HER2 ma e mafai ona tu'uina atu lana malosi cytotoxic payload (drug-to-antibody ratio, 8:1) e ala i le bystander effect i sela o le tumo tuaoi e eseese le fa'aalia o le HER2.

I le taimi nei, o loʻo tele pea suʻega faafomaʻi o tekinolosi fou e teteʻe ai i le kanesa i Saina o loʻo sailia ai ni gasegase. Mo feutagaiga i vailaʻau ma tekinolosi fou, e mafai ona e faʻafesoʻotaʻi le Matagaluega Faʻavaomalo a le Falemaʻi Oncology a le Itumalo i Saute o Beijing.

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