November 2022: Iko kusanganiswa kwecemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) uye platinum-based chemotherapy yevarwere vakuru vane yepamberi isiri-diki cell kenza yemapapu (NSCLC) isina EGFR, ALK, kana ROS1 abnormalities yakabvumidzwa neChikafu neChikafu. Administration.
Kudzidza 16113 (NCT03409614), muyedzo wakasarudzika, wakawanda, wepasirese, wakapetwa kaviri-mapofu, unoshingaira-unodzorwa muvarwere ve466 vane NSCLC yepamusoro vakanga vasati vamborapwa systemic kurapwa, vakaongorora kushanda kwenyaya iyi. Cemiplimab-rwlc pamwe neplatinum-based chemotherapy masvondo matatu ega ega 3 kutenderera, ichiteverwa necemiplimab-rwlc uye kuchengetedza chemotherapy, kana placebo pamwe neplatinum-based chemotherapy masvondo matatu ega ega mana, ichiteverwa ne placebo uye kuchengetedza chemotherapy, ndidzo nzira mbiri dzekurapa. inopiwa kuvarwere vakagoverwa (4: 3).
Kupona kwese kwaive kwekutanga kushanda kwemhedzisiro kuyerwa (OS). Progression-free survival (PFS) uye mwero wekupindura wakazara (ORR), sekutemerwa neyakapofumadzwa yakazvimirira yepakati wongororo, aive ekuwedzera efficacy mhedzisiro matanho (BICR).
Mukuenzanisa ne placebo pamwe nekemotherapy, cemiplimab-rwlc pamwe neplatinum-based chemotherapy yakaratidza kuwedzera kwakakosha uye kukiriniki kwakakosha mukupona kwese (OS) (hazard ratio [HR] ye0.71 [95% CI: 0.53, 0.93], mativi maviri p-kukosha = 0.0140). Mune cemiplimab-rwlc pamwe nechemotherapy ruoko, iyo yepakati OS yaive 21.9 mwedzi (95% CI: 15.5, isingaongororwe), zvichienzaniswa nemwedzi 13.0 (95% CI: 11.9, 16.1) mu placebo pamwe nekemotherapy boka. Mune cemiplimab-rwlc pamwe nechemotherapy ruoko, iyo yepakati PFS paBICR yaive mwedzi 8.2 (95% CI: 6.4, 9.3), nepo yaive mwedzi 5.0 (95% CI: 4.3, 6.2) mu placebo pamwe nechemotherapy ruoko (HR 0.56 ; 95% CI: 0.44, 0.70, p0.0001). Yakasimbiswa ORR paBICR pamishonga miviri iyi yaiva 43% (95% CI: 38, 49) uye 23% (95% CI: 16, 30).
Alopecia, marwadzo emusculoskeletal, kusvotwa, kupera simba, peripheral neuropathy, uye kuderera kwechido ndiko kwaiwanzoita mhedzisiro (15%).
350 mg IV mavhiki matatu ega ega ndiyo inokurudzirwa dose yecemiplimab-rwlc. Kuti uwane ruzivo rwedosi inokurudzirwa, sezvinodiwa, ona ruzivo rwekunyorerwa kwemishonga inoshandiswa pamwe necemiplimab-rwlc.
