Ukwamkelwa kwesicelo seLayisensi yeBiologics seTIVDAK sokuNyangwa kwezigulana ezineMetastatic okanye iRecurrent okanye iMetastatic Cervical Cancer

Ngomhla we-12 kweyoKwindla, ngo-2025, iZai Lab Limited yabhengeza ukuba i-National Medical Products Administration (NMPA) yaseTshayina isamkele isicelo seLayisensi yeBiologics (BLA) se-TIVDAK (tisotumab vedotin-tftv) sokunyanga izigulana ezinomhlaza womlomo wesibeleko ophindaphindayo okanye osasazekayo kunye nesifo esiqhubekekayo kunyango okanye emva konyango lwenkqubo.

Ukungeniswa kwe-BLA kuxhaswa ziziphumo ezivela kuvavanyo lweklinikhi lwe-innovaTV 301 lweSigaba sesi-3 lwehlabathi, olungacwangciswanga (NCT04697628) kunye neziphumo ezivela kwinani elincinci labantu baseTshayina kolu phononongo.

Izigulane ezingama-502 zizonke zafumana unyango olungaqhelekanga (ama-253 anikwa iqela le-vedotin le-tisotumab kwaye angama-249 anikwa iqela le-chemotherapy); la maqela ayefana ngokubhekiselele kwiimpawu zabantu kunye nezifo. Ukusinda okuphakathi bekukude kakhulu kwiqela le-vedotin le-tisotumab kunakwiqela le-chemotherapy (iinyanga ezili-11.5 [95% isithuba sokuzithemba {CI}, 9.8 ukuya kwi-14.9] xa kuthelekiswa neenyanga ezili-9.5 [95% CI, 7.9 ukuya kwi-10.7]), iziphumo ezimele umngcipheko ophantsi wama-30% wokufa nge-tisotumab vedotin kunange-chemotherapy (umlinganiselo wobungozi, 0.70; 95% CI, 0.54 ukuya kwi-0.89; two-side P=0.004). Ukusinda okuphakathi ngaphandle kokuqhubela phambili bekuziinyanga eziyi-4.2 (95% CI, 4.0 ukuya ku-4.4) nge-tisotumab vedotin kunye neenyanga eziyi-2.9 (95% CI, 2.6 ukuya ku-3.1) nge-chemotherapy (umlinganiselo wengozi, 0.67; 95% CI, 0.54 ukuya ku-0.82; two-side P<0.001). Izinga lokuphendula eliqinisekisiweyo yayiyi-17.8% kwiqela le-tisotumab vedotin kunye ne-5.2% kwiqela le-chemotherapy (umlinganiselo weengxaki, 4.0; 95% CI, 2.1 ukuya ku-7.6; two-side P<0.001). I-98.4% yezigulane kwiqela le-tisotumab vedotin kunye ne-99.2% kwiqela le-chemotherapy zinesiganeko esinye esibi esiye senzeka ngexesha lonyango (elichazwa njengexesha ukusuka kusuku loku-1 lwedosi yoku-1 ukuya kwiintsuku ezingama-30 emva kwedosi yokugqibela); Iziganeko zebanga lesi-3 okanye ngaphezulu zenzeke kwi-52.0% kunye ne-62.3%, ngokulandelelana. I-14.8% iyonke yezigulane ziye zayeka unyango lwe-tisotumab vedotin ngenxa yeziphumo ezinobungozi.

Malunga ne-TIVDAK (tisotumab vedotin-tftv)

I-TIVDAK (i-tisotumab vedotin) yi-antibody-drug conjugate (ADC) eyenziwe yi-antibody ye-Genmab's human monoclonal ejoliswe kwi-tissue factor (TF) kunye netekhnoloji ye-Pfizer's ADC esebenzisa i-protease-cleavable linker edibanisa i-microtubule-disrupting agent i-monomethyl auristatin E (MMAE) kwi-antibody. Idatha engekho yeklinikhi ibonisa ukuba umsebenzi we-tisotumab vedotin wokulwa nomhlaza ubangelwa kukubopha kwe-ADC kwiiseli zomhlaza ezibonisa i-TF, kulandele ukufakwa ngaphakathi kwe-ADC-TF complex, kunye nokukhululwa kwe-MMAE nge-proteolytic cleavage. I-MMAE iphazamisa inethiwekhi ye-microtubule yeeseli ezahlulahlula ngokusebenzayo, okukhokelela ekubanjweni komjikelo weseli kunye nokufa kweeseli ze-apoptotic. Kwi-vitro, i-tisotumab vedotin ikwalawula i-phagocytosis yeselula exhomekeke kwi-antibody kunye ne-antibody-dependent cellular cytotoxicity.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

Inombolo yefowuni: 4008803716

Email：myimmnet@163.com

Iireferensi

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.https://cn.zailaboratory.com/

3.I-Tisotumab Vedotin njengoNyango lweSibini okanye lweSithathu loMhlaza weSibeleko oPhindayo | Ijenali yezonyango yaseNew England (nejm.org)