August 2022: For adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH) breast cancer who have received prior chemotherapy in the metastatic setting or experienced a disease recurrence during or within six months of finishing adjuvant chemotherapy, the Food and Drug Administration has approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.).
DESTINY-Breast04 (NCT03734029), a randomised, multicenter, open-label clinical study that enrolled 557 patients with metastatic or unresectable HER2-low breast cancer, served as the foundation for the effectiveness analysis. In the study, there were two cohorts: 494 individuals with hormone receptor positivity (HR+) and 63 patients with hormone receptor negativity (HR-negative). In a centralised laboratory, IHC 1+ or IHC 2+/ISH- was used to characterise HER2-low expression. Enhertu 5.4 mg/kg was administered intravenously every three weeks to patients who were randomly assigned (2:1) to receive it or the physician’s choice of chemotherapy (N=184, including eribulin, capecitabine, gemcitabine, nab-paclitaxel, or paclitaxel).
The progression-free survival (PFS) rate in patients with HR+ kansarka naasaha, as determined by a blinded independent central review using RECIST 1.1, served as the key effectiveness measure. PFS in the total population (all randomised HR+ and HR-negative patients), overall survival (OS) in HR+ patients, and OS in the total population were secondary effectiveness endpoints.
Da'da bukaanku waxay u dhaxaysay 28 ilaa 81, iyadoo 57 ay ahaayeen dhexdhexaad, halka 24% ay ahaayeen 65 ama ka weyn. Liiska soo socda ee tirakoobyada la doortay ayaa la bixiyay: 99.6% dadku waa dumar, 48% waa cadaan, 40% waa Aasiyaan, 2% waa madow ama Afrikaan Mareykan ah, iyo 3.8% waa Hisbaanik/Latino.
Dhexdhexaadiyaha PFS ee kooxda HR + waxay ahayd 5.4 bilood kooxda kemotherabi iyo 10.1 bilood ee kooxda Enhertu (saamiga khatarta [HR] 0.51; 95% CI: 0.40, 0.64; p0.0001). Gacanta Enhertu, dhexdhexaadiyaha PFS wuxuu ahaa 9.9 bilood (95% CI: 9.0, 11.3), halka kuwa qaata kemotherabi, ay ahayd 5.1 bilood (95% CI: 4.2, 6.8) (HR 0.50; 95% CI: 0.40, 0.63; p0.0001).
Kooxda HR +, dhexdhexaadinta OS ee daaweynta kemotherabi iyo gacmaha Enhertu, siday u kala horreeyaan, waxay ahayd 17.5 bilood (95% CI: 15.2, 22.4) iyo 23.9 bilood (95% CI: 20.8, 24.8) (HR 0.64; 95% CI: 0.48; , 0.86; p=0.0028). Guud ahaan dadweynaha, dhexdhexaadinta OS ee kooxda Enhertu waxay ahayd 23.4 bilood (95% CI: 20.0, 24.8) iyo kooxda kiimoterabiga, waxay ahayd 16.8 bilood (95% CI: 14.5, 20.0) (HR 0.64; 95% CI) : 0.49, 0.84; p=0.001).
Tijaabadaan, shakhsiyaadka helay Enhertu inta badan waxay lahaayeen lallabbo, daal, alopecia, matag, dhiig-yaraan, calool-istaag, rabitaanka cuntada oo yaraatay, shuban, iyo xanuun murqo-xanuun. Digniin Sanduuqan oo ka digaysa xirfadlayaasha caafimaadka suurtagalnimada waxyeellada uurjiifka iyo uurjiifka iyo cudurrada sambabada dhexdooda ayaa lagu daray macluumaadka qorista.
Bukaanjiifka kansarka naasaha waa in ay helaan 5.4 mg/kg of Enhertu sida faleebo xididka hal mar saddexdii asbuucba (wareeg 21-maalmood ah) ilaa uu cudurku ka sii socdo ama ay jirto sun aan la aqbali karin.
U fiirso macluumaadka dhamaystiran ee Enhertu.
