Feb XXVIII: Enhertu (trastuzumab deruxtecan) ab AstraZeneca et Daiichi Sankyo Monotherapia probata est pro curatione aegrorum adultorum cum nonsectabili vel metastatico HER2-positivi cancer pectoris, qui unum vel plures ante diaetam anti-HER2 fundatam accepit.
Enhertu est species anticorpus pharmacum coniugatum (ADC) machinatum HER2 directum, quod AstraZeneca et Daiichi Sankyo coniunctim enucleantur et mercaturae sunt.
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 pectus cancer previously treated with trastuzumab and a taxan
In Sinis, cancer mammae maxime cancer inter mulieres procreatus est, cum supra 415,000 casus anno 2020 dignosciendos expectat.
1 Proxime 18% of cancri globalis mortibus in Sinis facta sunt anno 2020, cum fere 120,00 mortibus carcinomati carcinomatis attribuuntur. 1 Proxime unus ex omnibus quinque cancri pectoris casibus her2-positivus est. 2
Binghe Xu, MD, Professor et Director Department of Medical Oncologiae, Cancer Hospitalis et Institutum Cancri Hospitalis, Academiae Scientiarum Medicorum Sinensium, affirmavit, "Haec approbatio insigne miliarium repraesentat communitatis cancri pectoris in Sinis, sicut aegros cum HER2- positivus metastaticus cancer pectoris continuas curationi additionali requirere optiones. Quamvis curatio initialis, aegroti cum carcinomate metastatico HER2-positivo saepe morborum progressionem experiuntur, demonstrantes momentum morbi systemici primi temperantiae et potentiae pro Enhertu ut aegris metastatic carcinomate adiuventur qui ad curationem habiles sunt."
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, Caput Daiichi Sankyo's Asiae, Americae meridionalis et Centralis (ASCA) Negotia Unitas, dixit "Enhertu tempus dilatare ante morbum progressum vel mortem et adiuvans ad effectus reducendos aegros, cum antea curata her2-positiva metastatica cancer pectoris nunc medici in Sinis accessum habent ad hanc gravissimam medicinam aegrotis suis. Hoc approbante, Enhertu potentiam novam curandi in Sinis fieri habet pro aegris cum HER2-positivo metastatico cancri pectoris in secundo lineae occasu.
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 orci iudiciis, 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.
Haec approbatio sequitur Sinarum NMPA Breakthrough Therapy Designationem et Prioritatem Recognitio Enhertu propter hoc genus cancri pectoris anno 2022 .
Notes
Pectus cancer et HER2 expressio
Pectus cancer frequentissimus cancer est et una causa primarum mortum cancer relatarum per orbem terrarum.3 Plus quam duo miliones aegroti cum cancro pectorali anno 2020 praecogniti sunt, cum globally 685,000 fere mortibus.3 In Sinis, cancer pectoris frequentissimus est cancer in mulieribus, cum plus quam 415,000 aegros in 2020 dignoscitur.1 Fere 120,000 carcinomata sua funera in Sinis anno 2020 fuerunt, quae circa duodeviginti centenos carcinomatis globalis mortibus fuerunt.1 Proxime unus in quinque casibus cancri pectoris her2-positivi considerantur.2
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast, gastric, lung, and colorectal cancers.4 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and a poor prognosis in breast cancer.5
Quamquam curatio initial cum trastuzumab et taxane, aegroti cum carcinomate metastatico HER2-positivo progressionem morborum saepe experientur.6,7
DESTINY-Breast03
DESTINY-Breast03 est globalis, capitis-caput, randomised, pittacium apertum, registrationis III pars iudicii aestimandi efficaciam et salutem. Enhertu (5.4mg/kg) versus T-DM1 in patientibus her2-positivis irresectibilibus et/vel cancer metastatici ante pectus trastuzumab et taxane curati.
The primary efficacy endpoint of DESTINY-Breast03 is progression-free survival (PFS) based on blinded independent central review (BICR). Overall survival (OS) is a key secondary efficacy outcome measure. Other secondary efficacy endpoints include objective response rate (ORR), duration of response, PFS based on investigator assessment and safety. Primary results from DESTINY-Breast03 were published in De Nova Anglia Acta Medicine,8 cum updated PFS et OS proventus in SCALPELLUM.9
DESTINY-Breast03 enrolled 524 patients at multiple sites in Asia, Europe, North America, Oceania and South America.
Enhertu
Enhertu Her2 directa est ADC. Daiichi Sankyo DXd ADC technologiae proprietatis usus designatur, Enhertu est plumbum ADC in librarium Oncologiae Daiichi Sankyo et programmata antecedens in suggestu scientifico AstraZeneca ADC. Enhertu constat ex HER2 monoclonali anticorpori topoisomerasi I inhibitoris payload, derivativi exatecani, per stabilem tetrapeptidum substructum nexum cohaerentem.er.
Enhertu (5.4mg/kg) in plus quam 40 regionibus approbatur pro curatione aegrorum adultorum cum nonsectabili vel metastatico HER2-positivi carcinomatis pectoris, qui prius anti-HER2 victus rationem vel metastaticam accepit (vel unum vel plures) occasum vel in occasu neoadjuvante vel adjuvante, et morbum recurrentem elaboraverunt intra vel intra sex menses curationem perficiendi secundum eventum iudicii DESTINY-Breast03.
Enhertu (5.4mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridization [ISH]-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.
Enhertu (5.4mg/kg) is approved under accelerated approval in the US for the treatment of adult patients with unresectable or metastatic cellula parva non-pulmonis cancer 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 qui priorem regimen trastuzumab fundatum in eventibus iudicii FESTIN-Gastric01 et/vel iudicii DESTINY-Gastric02 fundatum acceperunt.
Enhertu progressio progressio
Progressio globalis progressionis comprehensive est citatus aestimandi efficaciam et salutem Enhertu monotherapy across multiple HER2-targetable cancers including breast, gastric, lung and colorectal cancer. Trials in combination with other anticancer treatments, such as immunotherapyquoque comparatis.
Daiichi Sankyo collaboration
Daiichi Sankyo Societas, Limitata (TSE: 4568) [relata ut Daiichi Sankyo] et AstraZeneca in globalem cooperationem inierunt ut coniunctim evolverent et mercaturam facerent. Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu ac datopotamab deruxtecan.
AstraZeneca in carcinomate
AstraZeneca astraZeneca incipit ad provocationem cancri pectoris biologiam agitatus, et refine, current orci paradigma quomodo cancrum pectus indicatur et tractatur ad curationes etiam validiores patientibus indigentibus liberare – cum audaci ambitione ad unum diem eliminare. pretium turpis ut causa mortis.
AstraZeneca librarium comprehensivum probatarum et promissionum compositionum in evolutione habet, quae varias machinas actionis pressiones biologice varias tumoris pectoris tumorem environment.
apud Enhertu HER2-directus ADC, AstraZeneca et Daiichi Sankyo (trastuzumab deruxtecan), a HER2-directus ADC, AstraZeneca et Daiichi Sankyo ad meliores exitus in antea tractatos HER2-positivos et HERXNUMX-low metastaticos cancer pectoris tractaverunt et suam potentiam explorant in lineis priorum curationis et in novis carcinomatis pectoribus.
In HR-positivo cancer pectoris, AstraZeneca pergit ad meliores exitus cum medicamentis fundamentis Faslodex (Fulvestrat) and * Zoladex (goserelin) and aims to reshape the HR-positive space with next-generation SERD and potential new medicine camizestrant, as well as a potential first-in-class AKT kinase inhibitor, capivasertib. AstraZeneca is also collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan, in this setting.
ightirab Matrix Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca and MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier diseases.
Ad bene curationem necessariam aegris cum cancro pectoris negativo triplicato, forma pugnaci cancri pectoris, AstraZeneca aestimat potentiam datopotamab deruxtecan solum et respectu immunotherapy. Imfinzi (durvalumab), capivasertib in compositione cum chemotherapy, et Imfinzi in compositione cum aliis medicamentis oncologiae, comprehendo Lynparza et Enhertu.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop, and deliver life-changing medicines to patients.
The company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.
AstraZeneca visionem habet ad curationem cancer redefine et, uno die, cancer causam mortis eliminare.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.
References
1. Wei Cao, et al. Cancri variae figurae onus terrarum et in Sinis: secunda analysis cancri globalis statisticae 2020 . J Chin med (Engl). 2021 Apr 5; 134 (7): 783-791.
2. Ahn S, et al. HER2 status in cancer pectus: mutationes in lineamenta et factores implicantes interpretationi. J Pathol Transl Med. 2020; 54(1): 34-44.
3. Canitur H, et al. Global Cancer Statistics 2020: GLOBOCAN Aestimationes Incidentiae et Mortalitatis Worldwide pro 36 Cancros in 185 regiones. CA Cancer J Clin. 2021; 10.3322/caac.21660.
4. Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014; 852748.
5. Pillai R, et al. HER2 mutations in lung adenocarcinomas: A report from the lung Cancer Mutation Consortium. Cancer. 2017;1;123(21):4099-4105.
6. Barok M, et al. Trastuzumab emtansine: Mechanismus actionis et resistentiae medicamentorum. Res. MMXVII; XVIII (VIII) MDCCXCIV.
7. Nader-Marta G, et al. Quomodo aegros cum carcinomate metastatico HER2-positivo carcinomatis tractamus. ESMO Open. 2022; vii 7;
8. Cortes J, et al. Trastuzumab Deruxtecan versus Trastuzumab Emtansine pro Cancro. N best J Med. 2022; 386: 1143, 1154.
9. Hurvitz S, et al. Trastuzumab deruxtecan versus trastuzumab emtansine in patientibus cum carcinomate metastatico HER2-positivo: renovatio proventuum e DESTINY-Breast03, a randomised, pittacium, phase 3 iudicii. SCALPELLUM. 2022 Dec 6;S0140-6736(22)02420-5.
