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Enhertu granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

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Based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a significant improvement in both progression-free survival and overall survival. Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers.

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) 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. Patients with hormone receptor (HR) positive breast cancer should additionally have received or be ineligible for endocrine therapy.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.

Up to half of all patients with breast cancer have tumours with a HER2 immunohistochemistry (IHC) score of 1+, or 2+ in combination with a negative in-situ hybridisation (ISH) test, a level of HER2 expression not currently eligible for HER2-targeted therapy.1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease.5

HER2 testing is routinely used to determine appropriate treatment options for patients with metastatic breast cancer. Targeting the lower range of expression in the HER2 spectrum may offer another approach to delay disease progression and extend survival in patients with metastatic breast cancer.6 Currently chemotherapy remains the only treatment option for patients with HR-positive tumours following progression on endocrine (hormone) therapy.7 Few targeted options are available for those who are HR-negative.8

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca said: “Today’s news is a significant validation of the potential we see for the historic DESTINY-Breast04 trial to enable a paradigm shift in how breast cancer is classified by targeting the full spectrum of HER2 expression. Enhertu continues to show transformative potential, and this milestone represents an important advance for patients with HER2-low metastatic breast cancer who are in urgent need of new treatment options and better outcomes.”

Ken Takeshita, Global Head, R&D, Daiichi Sankyo said: “Historically, only patients with HER2-positive metastatic breast cancer were shown to benefit from HER2-directed therapy. DESTINY-Breast04, in which Enhertu showed a clinically meaningful survival benefit in patients with HER2-low metastatic breast cancer, is the first trial to demonstrate that selecting patients for treatment based on low expression of HER2 has the potential to change the diagnostic and treatment paradigms for these patients. This Breakthrough Therapy Designation acknowledges the potential of Enhertu to fulfil an unmet medical need and we look forward to working closely with the FDA to bring the first HER2-directed therapy to patients with metastatic breast cancer whose tumours have lower levels of HER2 expression.

The FDA granted the BTD based on data from the pivotal DESTINY-Breast04 Phase III trial which reported positive high-level results in February 2022. In the trial, Enhertu demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer in all randomised patients with HR-positive and HR-negative disease versus physician’s choice of chemotherapy, which is the current standard of care. The safety profile of Enhertu was consistent with previous clinical trials with no new safety concerns identified. The data will be presented at an upcoming medical meeting.

This is the third BTD for Enhertu in breast cancer. Enhertu previously received BTD’s for the treatment of second-line HER2-positive metastatic breast cancer in 2021 and later-line HER2-positive metastatic breast cancer in 2017. Two additional BTD’s for Enhertu were granted in 2020 for HER2-mutant metastatic non-small cell lung cancer (NSCLC) and HER2-positive metastatic gastric cancer.

Notes

Breast cancer and HER2 expression

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide and in the US.9,10 More than two million cases of breast cancer were diagnosed in 2020 resulting in nearly 685,000 deaths globally.9 In the US, more than 290,000 new cases are expected to be diagnosed in 2022, resulting in more than 43,000 deaths.11

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, and is one of many biomarkers expressed in breast cancer tumours.12 HER2 expression is currently defined as either positive or negative, and is determined by an IHC test which measures the amount of HER2 protein on a cancer cell, and/or an ISH test which counts the copies of the HER2 gene in cancer cells.12,13 HER2-positive cancers are defined as IHC 3+ or IHC 2+/ISH+, and HER2-negative cancers are currently defined as IHC 0, IHC 1+ or IHC 2+/ISH-.12

DESTINY-Breast04

DESTINY-Breast04 is a global, randomised, open-label, registrational Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel) in patients with HR-positive (n=480) or HR-negative (n=60) HER2-low unresectable and/or metastatic breast cancer previously treated with one or two prior lines of chemotherapy. Patients were randomised 2:1 to receive either Enhertu or chemotherapy.

The primary endpoint of DESTINY-Breast04 is PFS in patients with HR-positive disease based on blinded independent central review (BICR). Key secondary endpoints include PFS based on BICR in all randomised patients (HR-positive and HR-negative disease), OS in patients with HR-positive disease and OS in all randomised patients (HR-positive and HR-negative disease). Other secondary endpoints include PFS based on BICR and investigator assessment, duration of response based on BICR and safety.

DESTINY-Breast04 enrolled approximately 540 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

Enhertu (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu development programme

A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Regulatory applications for Enhertu are currently under review in Europe, Japan, the US and several other countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen based on the results from the DESTINY-Breast03 trial.

Enhertu is also currently under review in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 (ERBB2) mutation and who have received a prior systemic therapy, and in Europe for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2 based regimen based on the DESTINY-Gastric01 and DESTINY-Gastric02 trials.

Daiichi Sankyo collaboration

Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as Daiichi Sankyo] and AstraZeneca entered into a global collaboration to jointly develop and commercialise 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 manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in breast cancer

Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation oral selective oestrogen receptor degrader (SERD) and potential new medicine camizestrant.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in HER2-negative early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease.

Building on the first approval of Enhertu, a HER2-directed ADC, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings.

To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi (durvalumab) in combination with other oncology medicines, including Lynparza and Enhertu, evaluating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

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 has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation 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. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Contacts
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References

  1. Ahn S, et al. HER2 status in breast cancer: changes in guidelines and complicating factors for interpretation. J Pathol Transl Med. 2020; 54(1): 34-44.
  2. Schalper K, et al. A retrospective population-based comparison of HER2 immunohistochemistry and fluorescence in situ hybridization in breast carcinomas. Arch Pathol Lab Med. 2014; 138:213-219.
  3. Schettini F, et al. Clinical, pathological, and PAM50 gene expression features of HER2-low breast cancer. npj Breast Cancer. 2021; 7:1 ; https://doi.org/10.1038/s41523-020-00208-2.
  4. Denkert C, et al. Clinical and molecular characteristics of HER2-low-positive breast cancer: pooled analysis of individual patient data from four prospective, neoadjuvant clinical trials. 2021. Lancet Oncol; 22: 1151–61.
  5. Miglietta F, et al. Evolution of HER2-low expression from primary to recurrent breast cancer. NPJ Breast Cancer. 2021; 7:137; 10.1038/s41523-021-00343-4.
  6. Eiger D, et al. The Exciting New Field of HER2-Low Breast Cancer Treatment. Cancers. 2021; 10.3390/cancers13051015.
  7. Matutino A, et al. Hormone receptor–positive, HER2-negative metastatic breast cancer: redrawing the lines. Current Oncology. 2018; 25(S1):S131-S141.
  8. American Cancer Society. Breast Cancer Hormone Receptor Status. Available at: https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-hormone-receptor-status.html. Accessed April 2022.
  9. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021; 10.3322/caac.21660.
  10. CDC. United States Cancer Statistics: Data Visualizations. Available at: https://gis.cdc.gov/Cancer/USCS/#/AtAGlance/. Last accessed: April 2022.
  11. American Cancer Society. Cancer Facts & Figures 2022. Available at: https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2022.html. Last accessed: April 2022.
  12. Iqbal N, et al. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;852748.
  13. Wolff A, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. Arch Pathol Lab Med. 2018; 142 (11): 1364-1382.
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Aixia tar ny order med befintlig kund, värde 25 MSEK

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Mölndal                                                                                      2024-03-29

Aixia tar en ny order med befintlig kund som är verksam inom mjukvarubranschen med inriktning mot AI och Automotive. Kunden investerar i ny lagring, arkivering och nätverk. Affären bygger på innovativ teknologi från IBM och Arista Networks.

Leverans kommer att ske under Q2.

Vi tackar för fortsatt förtroende. Vi konstaterar att vi fortsätter att stärka vår position inom AI säger Mattias Bergkvist, VD för Aixia.

Denna information är sådan information som Aixia Group AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande 2024-03-29

FÖR MER INFORMATION /

Kontakta företaget:

Mattias Bergkvist, VD

Telefon: 031-762 02 40

info@aixia.se

www.aixia.se

Aixia Group AB (publ)

Taljegårdsgatan 11

431 53 Mölndal

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Kinda Brave Entertainment Group AB (publ) lanserar Go Fight Fantastic! och Distant Bloom

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Umeå, 29 mars 2024 

Kinda Brave Entertainment Group AB (publ) (“Kinda Brave”), en modern spelkoncern som i dagarna har lanserat två efterlängtade speltitlar – Go Fight Fantastic! och Distant Bloom på den globala marknaden.  

Lanseringarna utgör viktiga milstolpar för koncernen i vår strävan efter att leverera högkvalitativa produkter på den globala spel- och underhållningsmarknaden. Vi ser med tillförsikt framemot att fortsätta arbetet med att synliggöra och utveckla våra produkter samt leverera exceptionella spelupplevelser av hög kvalitet till vår målgrupp. 

Kort om Distant Bloom 

Distant Bloom erbjuder ett fridfullt äventyr på en främmande planet, fokuserat på att återuppbygga dess naturliga miljö och etablera en blomstrande gemenskap med dina kamrater. Spelet tar med dig på en  resa genom olika biomer där du kan hantera resurser, plantera frön, samla material och bevittna naturens blomstring framför dina ögon, allt utan press eller strid.  

Du kommer att ha möjlighet att fördjupa dig i avslappnande ljud och visuella upplevelser, vilket gör att du kan lösa mysteriet kring vad exakt som hände där innan din besättning anlände och ledde till planetens undergång. 

Se trailer: https://www.youtube.com/watch?v=oULQk3lcod8

Steam: https://store.steampowered.com/app/1450250/Distant_Bloom/

Kort om Go Fight Fantastic! 

Go Fight Fantastic! är ett snabbt, handritat arkadstil hack-and-slash-spel som du eller dina vänner kan spela i en vacker, färgglad och livlig värld fylld med action från början till slut. Spelet erbjuder två spellägen: Story Mode, där du kommer att resa genom 6 unika biomer och Horde Mode, där du kan testa dina färdigheter mot oändliga vågor av fiender. 

Se trailer: https://www.youtube.com/watch?v=vih4UJo4p3g

Steam: https://store.steampowered.com/app/1183530/Go_Fight_Fantastic/

För mer information, vänligen kontakta:  

ir@kindabrave.com

www.kindabrave.com 

Följ gärna oss på Linkedin:  

https://www.linkedin.com/company/kinda-brave/

Om Kinda Brave Entertainment Group AB (publ) 

Kinda Brave är en modern spelkoncern, fokuserat på att förvärva, äga och utveckla spelstudios och immateriella rättigheter, samt utveckla en division inriktad mot förläggning av speltitlar från tredjepart. Idag består Bolaget av fyra spelstudior och ett mindre förläggarteam. Kinda Braves vision är att skapa en unik underhållningsgrupp, med starka immateriella rättigheter inom olika områden, inklusive TV-serier, filmer och serietidningar. 

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Månadsrapport mars, 03-2024

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De första vårtecknen har vi fått se under månaden som gått – eller rättare sagt, publicering av årsredovisning och kallelse till årsstämman. Årsredovisningen hittar du på vår hemsida under finansiella rapporter, och kallelse till årsstämma hittar du i pressmeddelande 04.

Bofaktabladen för kv. Hercules finns ute på hemsidan för den som är nyfiken att se hur lägenheterna kommer att se ut i det norra husets 40 olika lägenheter. i dagsläget kan du se dem i två olika filer, en fil för varje uppgång. Framgent kommer varje lägenhet publiceras för sig.

K21 rapporterar att arbeten pågår med källarväggar för det södra huset. Arbeten med stommen och utfackningsväggarna för det norra huset fortsätter fram till augusti. Vid sidan av detta sker arbeten med dagvattenmagasin och rörkulvert, samt återfyllnad av mark mot källarväggarna.

Uthyrningen av det norra huset har vi startat och det är vår Sofia som är ansvarig för projektet. Lägenheterna tilldelas genom vår bostadskö, som man också hittar mer info om på vår hemsida.

Handläggningen för ansökan om ändrad detaljplan för fastigheten fortsätter och SBF har varit ute på plats och fått sig en uppfattning om fastigheten. Vi försöker ha tålamod när vi väntar på alla förberedelser och steg i processen som alltid sker i liknande ärende hos kommunen.

Ett annat varmt välkommet ”vårtecken” är det senaste uttalandet från Riksbanken att inflationen är på väg att stabiliseras och om inflationsutsikterna fortsätter att vara gynnsamma kan styrräntan troligen sänkas i maj eller juni. Vi ser fram emot att se hur de utlovade räntesänkningarna påverkar de lån vi omförhandlar framöver.

Torslanda-Öckerötidningen rapporter att den konkreta byggstarten för batterifabriken togs i mitten av mars, anläggningsarbetet startade dock i höstas. Totala ytan för batterifabriken kommer uppgå till 175 000 m2 och beräknas innebära investeringar om ca 23 miljarder kronor. När fabriken är klar kommer den ha en kapacitet att bygga ca 250 000 bilar om året, eller med andra ord en kapacitet 20 gigawattimmar. Möjlighet kommer finnas att utöka till 50 gigawattimmar om året. Enligt VD för Västsvenska handelskammaren innebär utlovandet av 3 000 nya jobb till fabriken i förlängningen upp till 3 eller 4 gånger så många arbetstillfällen. Detta bör betyda att efterfrågan på bostäder, både permanenta hyresrätter och tillfälliga boendeformer som finns i vårt lägenhetshotell, kommer att öka i Torslanda och kringliggande områden. 

Snart är vi klara med anställningsprocessen och kan välkomna en ny biträdande förvaltare till vårt team. Det stora antalet ansökningar vi haft vittnar om att det kan vara svårt att få arbete i dagens konjunkturläge för de som läser med inriktning mot fastigheter och förvaltning. För vår del har detta inte varit en nackdel utan snarare tvärtom, då vi haft förmånen att få se många kvalitativa CV och träffa flera väldigt goda kandidater. Jag är säker på att den person som vi till sist kommer överens med om anställning kommer kunna bidra med mycket gott till företaget.

Glad påsk!

På återhörande.

Emilie Loft
VD

Emilie Loft
0709 76 89 03
emilie@amhult2.se

Amhult 2 AB är ett fastighetsbolag som prospekterar 44 000 m2 mark i Amhult, Torslanda, för att bygga ett nytt modernt köpcenter samt boendeområde i blandad stadsbebyggelse. En av idéerna är att området skall förena stadens och landets fördelar. Amhult 2 är noterat på Spotlight Stock Market sedan den 16 maj 2005 under kortnamnet AMH2 B och handlas via banker och fondkommissionärer.

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 Postflyget 7
423 37 Torslanda
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