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+ kenza yebonde, 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.
Mazera evarwere aibvira pamakumi maviri nemasere kusvika pamakumi masere nerimwe, aine makumi mashanu nevanomwe vari vepakati, nepo 28% vaive makumi matanhatu neshanu kana kupfuura. Rondedzero inotevera yenhamba dzakasarudzwa yakapihwa: 81% yehuwandu vanhukadzi, 57% Vachena, 24% ndeveAsia, 65% vatema kana veAfrica America, uye 99.6% ndevaHispanic/Latino.
Iyo yepakati PFS muHR + cohort yaive mwedzi 5.4 muboka rechemotherapy uye 10.1 mwedzi muboka reEnhertu (hazard ratio [HR] 0.51; 95% CI: 0.40, 0.64; p0.0001). Muruoko rweEnhertu, iyo yepakati PFS yaive mwedzi 9.9 (95% CI: 9.0, 11.3), nepo kune avo vanotora chemotherapy, yaive mwedzi 5.1 (95% CI: 4.2, 6.8) (HR 0.50; 95% CI: 0.40, 0.63; p0.0001).
MuHR + cohort, iyo yepakati OS yechemotherapy neEnhertu maoko, zvichiteerana, yaive mwedzi 17.5 (95% CI: 15.2, 22.4) uye 23.9 mwedzi (95% CI: 20.8, 24.8) (HR 0.64; 95% CI: 0.48. , 0.86; p=0.0028). Muhuwandu hwevanhu, iyo yepakati OS yeboka reEnhertu yaive mwedzi 23.4 (95% CI: 20.0, 24.8) uye yeboka rechemotherapy, yaive mwedzi gumi nematanhatu (16.8% CI: 95, 14.5) (HR 20.0; 0.64% CI : 95, 0.49; p=0.84).
Muchiyedzo ichi, vanhu vakagamuchira Enhertu kazhinji kazhinji vaive nekusvotwa, kuneta, alopecia, kurutsa, kupererwa neropa, kupererwa, kuderera kwechido, manyoka, uye kurwadziwa kwetsandanyama. Yambiro ine Boxed inozivisa varapi nezve mukana wekukuvadzwa kwe "embryo-fetal" uye chirwere chemapapu chemukati chinosanganisirwa muruzivo rwekuraira.
Varwere vegomarara remazamu vanofanira kugamuchira 5.4 mg/kg yeEnhertu semutsinga wemutsinga kamwe chete mavhiki matatu (pamazuva makumi maviri nerimwe) kusvikira chirwere ichi chichikura kana kuti pane huturu husingagamuchirwi.
Wona ruzivo rwakazara rwekurayira Enhertu.
