Toripalimab-tpzi inotenderwa neFDA yenasopharyngeal carcinoma

Muna Octoberr 2023, iyo FDA yakabvumidza toripalimab-tpzi (LOQTORZ, Coherus BioScience, Inc.) ine cisplatin uye gemcitabine semutsetse wekutanga kurapwa kune vanhu vane munharaunda yepamusoro kenza yenasopharyngeal (NPC) yakapararira kana kudzoka. Iyo FDA yakabvumidza toripalimab-tpzi semushonga mumwe chete wevakuru vane inodzokororwa isingadzokerike kana metastatic NPC iyo yakafambira mberi panguva kana mushure meplatinamu-ine chemotherapy.

Kushanda kwe toripalimab-tpzi ine cisplatin uye gemcitabine yakaongororwa muJUPITER-02 (NCT03581786), nzvimbo yakasiyana-siyana, yakasiyana-siyana, nzvimbo imwe chete, mapofu maviri-mapofu, e-placebo-controlled controlled test yevarwere ve289 vane metastatic kana kuti vakadzoka, veNPC yepamusoro avo vakanga vasina. yakambogamuchira systemic chemotherapy yekudzokazve kana metastatic chirwere. Varwere vakagoverwa (1: 1) kuti vagamuchire toripalimab-tpzi ine cisplatin uye gemcitabine, inoteverwa ne toripalimab-tpzi, kana placebo ine cisplatin uye gemcitabine, inoteverwa ne placebo. Kuti uwane ruzivo rwakakwana nezve chemotherapy regimens, ndapota ona chinongedzo chiri pamusoro.

Chiyero chakakosha chemhedzisiro yekubudirira kwaive kufambira mberi-kusina kupona (PFS), sekutsanangurwa neBlinded Independent Review Committee (BIRC) vachishandisa RECIST v1.1. Kupona kwese (OS) yaive imwe mhedzisiro. Musanganiswa we toripalimab-tpzi wakaratidza kuvandudzwa kwenhamba muPFS, nepakati PFS yemwedzi 11.7 maringe ne8.0 mwedzi (hazard ratio [HR] 0.52 [95% CI: 0.36, 0.74], p-value=0.0003). Kuvandudzwa kwakakosha muOS kwakaonekwawo, nemedian OS haina kuwanikwa (95% CI: 38.7 mwedzi, isingafungidzike) ye toripalimab-tpzi-ine regimen uye 33.7 mwedzi (95% CI: 27.0, 44.2) ye placebo- ine regimen (HR 0.63 [95% CI: 0.45, 0.89], p=0.0083).

POLARIS-02 (NCT02915432) yaive yakavhurika-label, multicenter, nyika imwe chete, multicohort muedzo muvarwere ve172 vane unresectable kana metastatic NPC avo vakambogamuchira platinum-based chemotherapy kana kufambira mberi kwechirwere mukati memwedzi ye6 yekupedzwa kweplatinum-based chemotherapy inotungamirwa. se neoadjuvant, adjuvant, kana definitive chemoradiation kurapwa kwechirwere chepamusoro chemunharaunda. Varwere vakapiwa toripalimab-tpzi kusvikira kufambira mberi kwechirwere neRECIST v1.1 kana huturu husingaregi.

Makiyi ekubudirira kwemhedzisiro zviyero zvakasimbiswa huwandu hwekupindura (ORR) uye nguva yekupindura (DOR), sekutsanangurwa neBIRC uchishandisa RECIST v1.1. Iyo ORR yaive 21% (95% CI: 15, 28), ine yepakati DOR yemwedzi 14.9 (95% CI: 10.3, isingafungidzirwe).

Toripalimab-tpzi yakaguma nemhinduro dzakaipa dzekudzivirira dziviriro dzakadai sepneumonitis, colitis, hepatitis, endocrinopathies, nephritis nekutadza kwetsvo, uye kuita kweganda. Toripalimab-tpzi ine cisplatin uye gemcitabine yakakonzera maitiro akajairika akashata (≥20%), kusanganisira kuda kurutsa, kurutsa, kuderera kwechido, kuvimbiswa, hypothyroidism, rash, pyrexia, manyoka, peripheral neuropathy, kukosora, kurwadziwa kwetsandanyama, kushaya hope, kufema kwepamusoro, , dzungu, uye malaise. Kuneta, hypothyroidism, uye musculoskeletal kusagadzikana ndizvo zvakanyanya kuipa zvakanyanya (≥20%) zvakashumwa ne toripalimab-tpzi semushonga mumwe chete.

Chiyero chinokurudzirwa che toripalimab-tpzi ine cisplatin uye gemcitabine i240 mg mavhiki matatu ega ega kusvika pakukura kwechirwere, huturu husingagoneki, kana kusvika kumwedzi makumi maviri nemana. Chiyero chinokurudzirwa che toripalimab-tpzi semushonga mumwe chete weNPC yakamborapwa i24 mg/kg mavhiki maviri ega ega kusvikira chirwere chakura kana kuti muchetura usingagamuchirwi.

Wona ruzivo rwakazara nezveLOQTORZI