Kukadzi 2023: Enhertu (trastuzumab deruxtecan) kubva kuAstraZeneca uye Daiichi Sankyo yakatenderwa semushonga wekurapwa kwevarwere vakuru vane isingarambiki kana metastatic HER2-positive cancer yemazamu avo vakagamuchira imwe kana anopfuura epamberi anti-HER2-based regimens.
Enhertu yakanyatso kugadzirwa HER2-inotungamirwa antibody drug conjugate (ADC) iyo AstraZeneca neDaiichi Sankyo vari kuvandudza pamwe nekutengesa.
In the DESTINY-Breast03 Phase III trial, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1) (hazard ratio [HR] 0.28; 95% confidence interval [CI] 0.22-0.37; p0.000001) in patients with HER2-positive unresectable and/or metastatic kenza yebonde previously treated with trastuzumab and a taxan
KuChina, gomarara rezamu ndiro gomarara rakanyanya kutekeshera pakati pevakadzi, uye vanhu vanopfuura mazana mana nemakumi mashanu ezviuru vari kutarisirwa kubatwa muna 415,000.
1 Vanosvika 18% yekufa kwegomarara repazamu pasi rose kwakaitika muChina muna 2020, nekufa kunoda kusvika zana nemakumi maviri nemazana maviri zvichikonzerwa negomarara rezamu. 120,00 Inosvika chikamu chimwe chete muzvishanu chega chega chegomarara rezamu iHER1-positive. 2
Binghe Xu, MD, Muzvinafundo uye Director weDhipatimendi reMedical Oncology, Cancer Hospital neInstitute Cancer Hospital, Chinese Academy of Medical Sciences, vakati, "Mvumo iyi inomiririra chiitiko chakakosha munharaunda yegomarara rezamu muChina, sevarwere vane HER2- positive metastatic cancer cancer inoramba ichida dzimwe nzira dzekurapa. Kunyangwe kurapwa kwekutanga, varwere vane HER2-positive metastatic cancer yemazamu vanowanzoona kufambira mberi kwechirwere, zvichiratidza kukosha kwekutanga systemic kudzora chirwere uye mukana weEnhertu kubatsira varwere vane metastatic cancer yemazamu avo vanokodzera kurapwa. "
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, stated, “This first approval of Enhertu in China represents a significant advancement in the treatment of HER2-targetable tumours and offers patients with previously treated HER2-positive metastatic breast cancer the opportunity to benefit from this important medication as a second line therapy. The approval demonstrates our commitment to patients in China, where the incidence of breast cancer has increased, as we continue to investigate the potential benefits of Enhertu in the treatment of HER2-directed metastatic breast cancer and other HER2-targetable cancers.
Kiminori Nagao, Mukuru weDaiichi Sankyo's Asia, South neCentral America (ASCA) Business Unit, akati, "Enhertu iri kuwedzera nguva isati yatanga chirwere kana kufa uye kubatsira kutsanangura patsva mhedzisiro yevarwere vakamborapwa HER2-positive metastatic cancer cancer, uye zvino vanachiremba muChina vachawana mushonga uyu unokosha kune varwere vavo. Nemvumo iyi, Enhertu ine mukana wekuve chiyero chitsva chekutarisira muChina kune varwere vane HER2-positive metastatic cancer yemazamu mumutsara wechipiri.
In DESTINY-Breast03, Enhertu’s safety profile was looked at in 257 patients with HER2-positive breast cancer that could not be removed or had spread to other parts of the body. It was similar to what had been seen in previous kliniki miedzo, and no new safety concerns were found. Nausea (75.9%), fatigue (49.4%), vomiting (49.0%), neutropenia (42.8%), and alopecia (37%) were the most common adverse reactions.
Mvumo iyi inotevera yekuChina's NMPA's Breakthrough Therapy Dhizaini uye Yekutanga Ongororo yeEnhertu yerudzi urwu rwegomarara rezamu muna 2022.
Notes
Kenza yemazamu uye HER2 kutaura
Gomarara remuzamu ndiro gomarara rinonyanyozivikanwa uye ndiro riri kukonzera ndufu dzine chekuita negomarara pasi rose.3 Varwere vanodarika mamirioni maviri vakabatwa negomarara rezamu muna 2020, nekufa kunoda kusvika 685,000 pasi rose.3 KuChina, gomarara rezamu ndiro gomarara rinonyanya kupararira muvakadzi, nevarwere vanopfuura zviuru mazana mana nemakumi mashanu vakaonekwa muna 415,000.1 Pakanga paine vangangoita zviuru zana nemakumi maviri vakafa negomarara rezamu muChina muna 120,000, vachimiririra vangangosvika 2020% yekufa kwegomarara rezamu pasi rose.1 Inenge imwe muzviitiko zvishanu zvegomarara rezamu inoonekwa seHER2-positive.2
HER2 inonzi tyrosine kinase receptor kukura-inokurudzira puroteni inoratidzwa pamusoro pemhando dzakawanda dzemamota dzinosanganisira mazamu, gastric, mapapu, uye colorectal cancers.4 HER2 protein overexpression inogona kuitika semugumisiro weHER2 gene amplification uye inowanzobatanidzwa nechirwere chinotyisa. uye fungidziro yakaipa mugomarara rezamu.5
Zvisinei nekutanga kurapwa netrastuzumab uye taxane, varwere vane HER2-positive metastatic cancer yemazamu vanowanzoona kufambira mberi kwechirwere.6,7
DESTINY-Zamu03
DESTINY-Breast03 ndeyepasi rose, musoro-kune-musoro, isina kurongeka, yakavhurika-label, yekunyoresa Phase III bvunzo inoongorora kushanda uye kuchengetedzeka kwe. Enhertu (5.4mg/kg) maringe neT-DM1 muvarwere vane HER2-positive isingagadzirisiki uye/kana metastatic kenza yemazamu yakamborapwa netrastuzumab uye taxane.
Iyo yekutanga kushanda kwekupedzisira kweDESTINY-Breast03 ndeyekufambira mberi-kusina kupona (PFS) zvichibva pakupofumadzwa kwakazvimirira kwepakati wongororo (BICR). Kupona kwese (OS) chinhu chakakosha chechipiri chekuita mhedzisiro chiyero. Mamwe magumo ekupedzisira ekubudirira anosanganisira chinangwa chekupindura mwero (ORR), nguva yekupindura, PFS yakavakirwa pamuongorori wekuongorora uye chengetedzo. Mhedzisiro yekutanga kubva kuDESTINY-Breast03 yakaburitswa mukati The New England Journal of Medicine,8 ine yakagadziridzwa PFS uye OS mhedzisiro yakaburitswa mukati The Lancet.9
DESTINY-Breast03 enrolled 524 patients at multiple sites in Asia, Europe, North America, Oceania and South America.
Enhertu
Enhertu iri HER2-inotungamirwa ADC. Yakagadzirwa uchishandisa Daiichi Sankyo's proprietary DXd ADC tekinoroji, Enhertu ndiyo inotungamira ADC mune oncology portfolio yeDaiichi Sankyo uye chirongwa chepamusoro-soro muAstraZeneca's ADC sainzi papuratifomu. Enhertu ine HER2 monoclonal antibody yakasungirirwa kune topoisomerase I inhibitor payload, exatecan derivative, kuburikidza yakagadzikana tetrapeptide-based cleavable link.Er.
Enhertu (5.4mg/kg) inobvumirwa munyika dzinopfuura makumi mana kuitira kurapwa kwevarwere vakuru vane kenza yemazamu isingagadziriswi kana metastatic HER40-positive vakagamuchira (kana imwe kana kupfuura) isati yamborwisa-HER2-based regimen, ingave mune metastatic. kuseta kana mune neoadjuvant kana adjuvant marongero, uye vakagadzira kudzoka kwechirwere mukati kana mukati memwedzi mitanhatu yekupedza kurapa zvichibva pane zvabuda kubva muyedzo yeDESTINY-Breast2.
Enhertu (5.4mg/kg) inotenderwa munyika dzinopfuura makumi matatu kurapwa kwevarwere vakura vane unresectable kana metastatic HER30-low (immunohistochemistry [IHC] 2+ kana IHC 1+/in-situ hybridization [ISH]-) kenza yemazamu uyo vakagamuchira pre-systemic therapy mune metastatic setting kana kuvandudza chirwere chekudzoka mukati kana mukati memwedzi mitanhatu yekupedza adjuvant chemotherapy zvichienderana nemigumisiro kubva kuDESTINY-Breast2 kuedza.
Enhertu (5.4mg/kg) is approved under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic isina-diki kenza yemapapu kenza whose tumours have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Enhertu (6.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma avo vakagamuchira yekutanga trastuzumab-yakavakirwa regimen zvichibva pane zvabuda kubva kuDESTINY-Gastric01 kuyedza uye/kana DESTINY-Gastric02 kuyedza.
Enhertu chirongwa chebudiriro
Chirongwa chakazara chebudiriro yepasi rose chiri kuitika kuongorora kushanda uye kuchengetedzeka kwe Enhertu monotherapy across multiple HER2-targetable cancers including breast, gastric, lung and kenza dzakajeka. Trials in combination with other anticancer treatments, such as immunotherapy, zviri kuitikawo.
Daiichi Sankyo kubatana
Daiichi Sankyo Company, Limited (TSE: 4568) [inonzi Daiichi Sankyo] neAstraZeneca vakapinda mumubatanidzwa wepasi rose kusimudzira pamwe nekutengeserana. Enhertu (a HER2-inotungamirwa ADC) muna Kurume 2019, uye datopotamab deruxtecan (DS-1062; TROP2-inotungamirwa ADC) muna Chikunguru 2020, kunze kwekuJapan uko Daiichi Sankyo ane kodzero dzakakwana. Daiichi Sankyo ndiye ane basa rekugadzira uye kugovera Enhertu uye datopotamab deruxtecan.
AstraZeneca mugomarara rezamu
Inotungamirwa nekunzwisisa kuri kukura kwekenza yemazamu biology, AstraZeneca yave kutanga kupikisa, uye kutsanangurazve, iyo yazvino kiriniki paradigm yekuti gomarara rezamu rinoiswa sei uye rinorapwa sei kuendesa kurapa kwakanyanya kune varwere vanoshaya - nechishuwo chakashinga kuti rimwe zuva ribvise. gomarara rezamu sechikonzero cherufu.
AstraZeneca ine yakazara portfolio yemakomisheni akatenderwa uye anovimbisa mukusimudzira ayo anowedzera nzira dzakasiyana dzekuita kugadzirisa nharaunda dzakasiyana siyana dzegomarara rezamu.
ne Enhertu (trastuzumab deruxtecan), HER2-inotungamirwa ADC, AstraZeneca uye Daiichi Sankyo vari kuvavarira kuvandudza mhedzisiro mune yakamborapwa HER2-positive uye HER2-yakaderera metastatic cancer yemazamu uye vari kuongorora kugona kwayo mumitsara yekutanga yekurapa uye mune itsva marongero egomarara rezamu.
MuHR-positive cancer cancer, AstraZeneca inoenderera mberi nekuvandudza mhedzisiro nemishonga yekutanga Faslodex (fulventant) uye Zoladex (goserelin) uye ine chinangwa chekugadzirisa zvakare HR-positive nzvimbo nechizvarwa chinotevera SERD uye inogona kuve yemushonga mutsva camizestrant, pamwe neanogona kutanga-mu-kirasi AKT kinase inhibitor, capivasertib. AstraZeneca iri kushanda zvakare naDaiichi Sankyo kuongorora kugona kweTROP2-inotungamirwa ADC, datopotamab deruxtecan, mugadziriro iyi.
PARP inhibitor Lynparza (olaparib) isarudzo yakanangwa yekurapa iyo yakadzidziswa mukutanga uye metastatic cancer yemazamu varwere vane nhaka yeBRCA mutation. AstraZeneca uye MSD (Merck & Co., Inc. muUS neCanada) vanoramba vachitsvaga Lynparza muzvirongwa izvi uye kuongorora kugona kwayo muzvirwere zvekare.
Kuunza nzira dzekurapa dzinodiwa kune varwere vane kenza yemazamu ine katatu isina kunaka, chimiro chehasha chegomarara rezamu, AstraZeneca iri kuongorora kugona kwedatopotamab deruxtecan chete uye pamwe chete neimmunotherapy. Imfinzi (durvalumab), capivasertib pamwe chete nechemotherapy, uye Imfinzi pamwe chete nemimwe mishonga yeoncology, kusanganisira Lynparza uye Enhertu.
AstraZeneca mune oncology
AstraZeneca iri kutungamira shanduko mune oncology neshuviro yekupa mishonga yegomarara nenzira dzese, ichitevera sainzi kuti inzwisise gomarara uye kuoma kwayo kwese kutsvaga, kugadzira, uye kuendesa mishonga inoshandura hupenyu kuvarwere.
Iyo kambani inotarisisa kune mamwe emagomarara akaomarara. Kuburikidza nekuenderera mberi kwekuvandudza iyo AstraZeneca yakavaka imwe yeakasiyana-siyana mapotifolio uye mapaipi muindasitiri, ine mukana wekukonzeresa shanduko mukuita kwekurapa uye kushandura ruzivo rwemurwere.
AstraZeneca ine chiono chekutsanangudza kutarisirwa kwegomarara uye, rimwe zuva, kubvisa gomarara sechikonzero cherufu.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) ikambani yepasirese, inotungamirwa nesainzi biopharmaceutical kambani inotarisa kuwanikwa, kusimudzira, uye kutengeswa kwemishonga yemishonga muOncology, Rare Diseases, uye BioPharmaceuticals, kusanganisira Cardiovascular, Renal & Metabolism, uye Respiratory. & Immunology. Yakavakirwa muCambridge, UK, AstraZeneca inoshanda munyika dzinopfuura zana, uye mishonga yayo yekuvandudza inoshandiswa nemamiriyoni evarwere pasi rese.
References
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