August 2023: Dostarlimab-gxly (Jemperli, GlaxoSmithKline), ichiteverwa nedostarlimab-gxly semumiririri mumwe chete, yakatenderwa neFood and Drug Administration kurapwa kwegomarara rekutanga kana recurrent endometrial cancer (EC) iri kushomeka kwekugadzirisa (dMMR). yakatemerwa neFDA-yakatenderwa bvunzo, kana microsatellite kusagadzikana-yakakwirira (MSI-H).
RUBY (NCT03981796), chirongwa chisingaverengeki, chakawanda, mapofu maviri, placebo-inodzorwa muedzo, yakaongororwa kushanda. Chikwata chakafanotemerwa chevarwere ve122 vane yekutanga yepamusoro kana yakadzokororwa dMMR/MSI-H EC yakawana kuongororwa kwekuita. Kana data remunharaunda raisavapo, kuongororwa kwepakati (IHC) uchishandisa Ventana MMR RxDx Panel yakashandiswa kuongorora MMR/MSI bundu mamiriro.
Varwere vakapihwa zvisina tsarukano (1: 1) kugamuchira chero placebo ine carboplatin uye paclitaxel, ichiteverwa ne placebo, kana dostarlimab-gxly ine carboplatin uye paclitaxel, ichiteverwa nedostarlimab-gxly. Iyo link yambotaurwa inopa yakadzama yekutsanangura ruzivo pane akati wandei chemotherapy regimens. MMR/MSI mamiriro, yapfuura ekunze pelvic irradiation, uye chirwere nhanho (inodzokororwa, yekutanga Danho III, kana yekutanga Danho IV) zvese zvakaverengerwa pakurongedza maitiro ekusarongeka.
Investigator-assessed progression-free survival (PFS) achishandisa RECIST v. 1.1 ndiyo yaiva huru yemigumisiro yemigumisiro. Nepakati PFS ye30.3 maringe nemwedzi 7.7 (Hazard Ratio=0.29 [95% CI: 0.17, 0.50]; p-value0.0001) yedostarlimab-gxly uye placebo-ine regimens, zvichiteerana, kuvandudzwa kwePFS kwakaonekwa. muboka re dMMR/MSI-H.
Pneumonitis, colitis, hepatitis, endocrinopathies senge hypothyroidism, nephritis ine renal kutadza kushanda, uye ganda rakaipa mhinduro mienzaniso yeimmune-mediated adverse reactions inogona kuitika nedostarlimab-gxly. Rash, diarrhoea, hypothyroidism, uye hypertension ndizvo zvaiwanzoitika zviitiko zvakashata (20%) nedostarlimab-gxly pamwe chete necarboplatin uye paclitaxel. Kuti uwane runyoro rwakakwana rwemigumisiro, tarisa kune yakatemwa ruzivo.
Dostarlimab-gxly inofanirwa kupihwa muyero we500 mg masvondo matatu ega ega kwemadhora matanhatu ane carboplatin uye paclitaxel, kozoti 1,000 mg kamwe chete mumavhiki matanhatu kusvika hurwere hwakura kana kuti kune muchetura usingashiviriki, unogona kutora kusvika makore matatu. Kana yapihwa pazuva rimwechete nechemotherapy, dostarlimab-gxly inofanira kutanga yapihwa.
Wona ruzivo rwakazara rwekurayira Jemperli.
