Novemba 2022: Inhlanganisela ye-cemiplimab-rwlc (i-Libtayo, i-Regeneron Pharmaceuticals, Inc.) kanye ne-chemotherapy esekelwe ku-platinum yeziguli ezikhulile ezinomdlavuza wamaphaphu ongewona omncane omncane (NSCLC) ngaphandle kwe-EGFR, ALK, noma i-ROS1 okungavamile kugunyazwe yi-Food and Drug. Ukuphatha.
I-Study 16113 (NCT03409614), ukuhlolwa okungahleliwe, okuxubile, kwamazwe ngamazwe, okungaboni kabili, okusebenzayo okulawulwayo ezigulini ze-466 ezine-NSCLC ethuthukisiwe ezazingakaze zithole ukwelashwa okuhleliwe, zihlole ukusebenza kahle kulokhu. I-Cemiplimab-rwlc kanye nokwelashwa ngamakhemikhali okusekelwe ku-platinum njalo emavikini angu-3 emijikelezweni emi-4, kulandelwa i-cemiplimab-rwlc kanye nokwelashwa ngamakhemikhali okulondolozwayo, noma i-placebo kanye nokwelashwa ngamakhemikhali okusekelwe ku-platinum njalo emavikini angu-3 emijikelezweni emi-4, elandelwa yi-placebo kanye nokwelashwa ngamakhemikhali okulondoloza, kwakuyizinketho ezimbili zokwelapha. enikezwa iziguli ezabelwa ngokungahleliwe (2:1).
Ukusinda sekukonke bekuyisilinganiso esiyinhloko somphumela wokusebenza kahle (OS). Ukusinda kwe-Progression-free survival (PFS) kanye nezinga lokuphendula lilonke (ORR), njengoba kunqunywe ukubuyekezwa okuzimele okuphuphuthekile, bekuyizinyathelo zomphumela ezisebenzayo ezengeziwe (BICR).
Uma kuqhathaniswa ne-placebo kanye nokwelashwa ngamakhemikhali, i-cemiplimab-rwlc kanye ne-platinum-based chemotherapy ibonise ukuthuthuka okuphawulekayo kwezibalo nokubalulekile emtholampilo ekusindeni kukonke (OS) (isilinganiso sengozi [HR] engu-0.71 [95% CI: 0.53, 0.93], izinhlangothi ezimbili p-value = 0.0140). Engalweni ye-cemiplimab-rwlc kanye ne-chemotherapy, i-OS emaphakathi yayiyizinyanga ezingama-21.9 (95% CI: 15.5, ayihloleki), uma kuqhathaniswa nezinyanga eziyi-13.0 (95% CI: 11.9, 16.1) eqenjini le-placebo kanye ne-chemotherapy. Engalweni ye-cemiplimab-rwlc kanye ne-chemotherapy, i-PFS emaphakathi nge-BICR ngayinye kwakuyizinyanga ezingu-8.2 (95% CI: 6.4, 9.3), kuyilapho kwakuyizinyanga ezingu-5.0 (95% CI: 4.3, 6.2) ku-placebo kanye nengalo ye-chemotherapy (HR 0.56 ; 95% CI: 0.44, 0.70, p0.0001). I-ORR eqinisekisiwe nge-BICR ngayinye yokwelashwa okubili yayingu-43% (95% CI: 38, 49) kanye nama-23% (95% CI: 16, 30).
I-alopecia, ubuhlungu be-musculoskeletal, isicanucanu, ukukhathala, i-peripheral neuropathy, nokuncipha kwesifiso sokudla kwakuyimiphumela emibi kakhulu (15%).
350 mg IV njalo emavikini amathathu umthamo ophakanyisiwe we-cemiplimab-rwlc. Ukuze uthole ulwazi lomthamo onconyiwe, njengoba kudingeka, bona imininingwane yokunquma yemithi esetshenziswa ngokuhambisana ne-cemiplimab-rwlc.
