{"id":72846,"date":"2026-06-29T18:39:18","date_gmt":"2026-06-29T18:39:18","guid":{"rendered":"https:\/\/www.europesays.com\/britain\/72846\/"},"modified":"2026-06-29T18:39:18","modified_gmt":"2026-06-29T18:39:18","slug":"astrazeneca-wins-eu-tumour-agnostic-nod-for-enhertu-azn-sec-filing","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/britain\/72846\/","title":{"rendered":"AstraZeneca wins EU tumour\u2011agnostic nod for Enhertu | AZN SEC Filing"},"content":{"rendered":"<p>FORM 6-K<\/p>\n<p>\u00a0<\/p>\n<p>\nSECURITIES<br \/>\nAND EXCHANGE COMMISSION<\/p>\n<p>\nWashington,<br \/>\nD.C. 20549<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\nReport<br \/>\nof Foreign Issuer<\/p>\n<p>\u00a0<\/p>\n<p>\nPursuant<br \/>\nto Rule 13a-16 or 15d-16 of<\/p>\n<p>\nthe<br \/>\nSecurities Exchange Act of 1934<\/p>\n<p>\n\u00a0<\/p>\n<p>\nFor the<br \/>\nmonth of June 2026\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\nCommission<br \/>\nFile Number: 001-11960<\/p>\n<p>\n\u00a0<\/p>\n<p>AstraZeneca PLC<\/p>\n<p>\n\u00a0<\/p>\n<p>\n1<br \/>\nFrancis Crick Avenue<\/p>\n<p>\nCambridge<br \/>\nBiomedical Campus<\/p>\n<p>\nCambridge<br \/>\nCB2 0AA<\/p>\n<p>\nUnited<br \/>\nKingdom<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\nIndicate<br \/>\nby check mark whether the registrant files or will file annual<br \/>\nreports under cover of Form 20-F or Form 40-F.<\/p>\n<p>\u00a0<\/p>\n<p>\nForm<br \/>\n20-F X Form 40-F __<\/p>\n<p>\u00a0<\/p>\n<p>\nIndicate<br \/>\nby check mark if the registrant is submitting the Form 6-K in paper<br \/>\nas permitted by Regulation S-T Rule 101(b)(1):<\/p>\n<p>\u00a0<\/p>\n<p>\nIndicate<br \/>\nby check mark if the registrant is submitting the Form 6-K in paper<br \/>\nas permitted by Regulation S-T Rule 101(b)(7): ______<\/p>\n<p>\u00a0<\/p>\n<p>\nIndicate<br \/>\nby check mark whether the registrant by furnishing the information<br \/>\ncontained in this Form is also thereby furnishing the information<br \/>\nto the Commission pursuant to Rule 12g3-2(b) under the Securities<br \/>\nExchange Act of 1934.<\/p>\n<p>\u00a0<\/p>\n<p>\nYes __<br \/>\nNo X<\/p>\n<p>\u00a0<\/p>\n<p>\nIf<br \/>\n\u201cYes\u201d is marked, indicate below the file number<br \/>\nassigned to the Registrant in connection with Rule 12g3-2(b):<br \/>\n82-_____________<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>AstraZeneca PLC<\/p>\n<p>\n\u00a0<\/p>\n<p>\nINDEX<br \/>\nTO EXHIBITS<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>1.<\/p>\n<p>\nEnhertu approved in EU for HER2+ solid tumours<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a029 June 2026<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0approved<br \/>\nin the EU as first tumour agnostic HER2-directed therapy and<br \/>\nantibody drug conjugate for patients with previously treated<br \/>\nHER2-positive metastatic solid tumours<\/p>\n<p>\u00a0<\/p>\n<p>Based on three Phase II trials of AstraZeneca and Daiichi Sankyo&#8217;s<br \/>\nEnhertu which demonstrated clinically meaningful responses across a<br \/>\nbroad range of tumours<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca and Daiichi Sankyo&#8217;s\u00a0Enhertu\u00a0(trastuzumab deruxtecan) has been approved<br \/>\nin the European Union (EU) as a monotherapy for the treatment of<br \/>\nadult patients with unresectable or metastatic HER2-positive<br \/>\n(immunohistochemistry [IHC] 3+) solid tumours who have received<br \/>\nprior treatment and who have no satisfactory treatment<br \/>\noptions.<\/p>\n<p>\u00a0<\/p>\n<p>The approval by the European Commission follows the positive<br \/>\nopinion of the Committee for Medicinal Products for Human Use<br \/>\n(CHMP) of the European Medicines Agency (EMA) and is based on<br \/>\nresults from a subgroup of patients with HER2-positive (IHC 3+)<br \/>\ntumours across three\u00a0Phase II trials,\u00a0DESTINY-PanTumor02,\u00a0DESTINY-Lung01\u00a0and\u00a0DESTINY-CRC02.<\/p>\n<p>\n\u00a0<\/p>\n<p>Benedikt Westphalen, MD, Head of the Precision Oncology Program,<br \/>\nComprehensive Cancer Center of the University of Munich, Germany,<br \/>\nsaid: &#8220;HER2 overexpression occurs across multiple tumour types and<br \/>\nis associated with aggressive disease and a poor prognosis. Until<br \/>\nnow, HER2-directed therapies were only available for specific<br \/>\ntumour types. The approval of trastuzumab deruxtecan as a<br \/>\ntumour-agnostic therapy opens a new treatment option for patients<br \/>\nwith HER2-positive cancers regardless of where the tumour<br \/>\noriginated.&#8221;<\/p>\n<p>\u00a0<\/p>\n<p>Dave Fredrickson, Executive Vice President, Oncology Haematology<br \/>\nBusiness Unit, AstraZeneca, said: &#8220;Precision medicine is reshaping<br \/>\ncancer care by helping inform treatment decisions based on the<br \/>\nmolecular and biological characteristics of a patient&#8217;s<br \/>\ndisease.\u00a0Enhertu\u00a0is already approved in\u00a0breast, gastric,<br \/>\nand lung cancers, and with this approval, clinicians may now<br \/>\nconsider\u00a0Enhertu\u00a0for<br \/>\npatients with\u00a0HER2-positive\u00a0status across multiple<br \/>\nadditional tumour types. This highlights the importance<br \/>\nof\u00a0biomarker testing\u00a0to identify eligible patients and<br \/>\nensure that those with\u00a0HER2-positive disease\u00a0are<br \/>\nconsidered for targeted treatment.&#8221;<\/p>\n<p>\u00a0<\/p>\n<p>Ken Keller, Global Head of Oncology Business, and President and<br \/>\nCEO, Daiichi Sankyo, Inc., said: &#8220;This approval<br \/>\nof\u00a0Enhertu\u00a0marks a significant milestone in the EU for<br \/>\npatients with HER2-positive metastatic solid tumours and<br \/>\nestablishes the first tumour-agnostic indication for a<br \/>\nHER2-directed therapy and antibody drug conjugate in the<br \/>\nregion.\u00a0Enhertu\u00a0is now approved for six indications in the<br \/>\nEU, which demonstrates our commitment to advancing innovative<br \/>\nmedicines in areas of high unmet need to patients with cancer.&#8221;<br \/>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>In the DESTINY-PanTumor02 Phase II trial,\u00a0Enhertu\u00a0demonstrated a confirmed objective response<br \/>\nrate (ORR) of 52.3%\u00a0(95% confidence interval [CI]<br \/>\n42.6-61.8)\u00a0and median duration of response (DOR) of 21.1<br \/>\nmonths\u00a0(95% CI 10.6-25.0)\u00a0in patients with previously<br \/>\ntreated centrally or locally assessed IHC 3+ solid tumours (n=111)<br \/>\nincluding biliary tract, bladder, cervical, endometrial,<br \/>\novarian,\u00a0pancreatic\u00a0or other tumours. In<br \/>\nDESTINY-Lung01,\u00a0Enhertu\u00a0demonstrated a confirmed ORR of<br \/>\n52.9%\u00a0(95% CI 27.8-77.0)\u00a0and median DOR of 6.9<br \/>\nmonths\u00a0(95% CI 4.0-9.8)\u00a0in patients with previously<br \/>\ntreated centrally confirmed IHC 3+ non-small cell lung cancer<br \/>\n(NSCLC) (n=17). In DESTINY-CRC02,\u00a0Enhertu\u00a0demonstrated a confirmed ORR of<br \/>\n46.9%\u00a0(95% CI 34.3-59.8)\u00a0and median DOR of 5.5<br \/>\nmonths\u00a0(95% CI 4.2-8.1)\u00a0in patients with previously<br \/>\ntreated centrally confirmed IHC 3+ colorectal cancer<br \/>\n(n=64).<\/p>\n<p>\u00a0<\/p>\n<p>The safety profile of\u00a0Enhertu\u00a0was based on a pooled analysis of patients<br \/>\nwith unresectable or metastatic HER2-positive (IHC 3+) solid<br \/>\ntumours enrolled in DESTINY-PanTumor02, DESTINY-Lung01,<br \/>\nDESTINY-CRC02 and DESTINY-Breast01, and was consistent with<br \/>\nprevious clinical trials, with no new safety concerns<br \/>\nidentified.<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0has received a<br \/>\ntumour agnostic indication in the US and other countries based on<br \/>\nthe DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02<br \/>\ntrials.<\/p>\n<p>\u00a0<\/p>\n<p>Additional regulatory submissions for\u00a0Enhertu\u00a0are under review in the EU, including in<br \/>\ncombination with pertuzumab for the 1st-line treatment of patients<br \/>\nwith unresectable or metastatic HER2-positive (IHC 3+ or ISH+)<br \/>\nbreast cancer based on data from the\u00a0DESTINY-Breast09\u00a0Phase<br \/>\nIII trial and for patients with HER2-positive (IHC 3+ or ISH+)<br \/>\nbreast cancer who have residual invasive disease after neoadjuvant<br \/>\nHER2-targeted treatment based on data from<br \/>\nthe\u00a0DESTINY-Breast05\u00a0Phase<br \/>\nIII trial.<\/p>\n<p>\u00a0<\/p>\n<p>\u200bEnhertu\u202fis a<br \/>\nspecifically engineered\u00a0HER2-directed\u202fDXd\u202fantibody<br \/>\ndrug conjugate (ADC) discovered by Daiichi Sankyo and being jointly<br \/>\ndeveloped and commercialised by AstraZeneca and Daiichi<br \/>\nSankyo.\u202f<\/p>\n<p>\u00a0<\/p>\n<p>Financial considerations<\/p>\n<p>Following this approval\u00a0in the EU, an amount of $25 million is due from<br \/>\nAstraZeneca to Daiichi Sankyo as a milestone payment for the<br \/>\ntumour-agnostic indication. Sales of\u00a0Enhertu\u00a0in most EU territories are recognised by<br \/>\nDaiichi Sankyo. For further details on the financial arrangements,<br \/>\nplease consult the collaboration agreement<br \/>\nfrom\u00a0March<br \/>\n2019.<\/p>\n<p>\u00a0<\/p>\n<p>Notes<\/p>\n<p>\u00a0<\/p>\n<p>HER2 expression in solid tumours<\/p>\n<p>HER2 is a tyrosine kinase receptor growth-promoting protein<br \/>\nexpressed on the surface of various tissue cells throughout the<br \/>\nbody and is involved in normal cell growth.1\u00a0HER2<br \/>\nprotein overexpression may occur as a result<br \/>\nof\u00a0HER2\u00a0gene amplification and is often associated<br \/>\nwith aggressive disease and poor prognosis in some<br \/>\ncancers.2\u00a0HER2<br \/>\noverexpression occurs in a range of solid tumours with the<br \/>\nprevalence varying by tumour type.3<\/p>\n<p>\u00a0<\/p>\n<p>HER2-directed therapies have been used to treat HER2 overexpression<br \/>\nin breast, gastric and biliary tract cancers in the<br \/>\nEU.1,4-6\u00a0Although<br \/>\nHER2 is overexpressed in additional solid tumour types including<br \/>\nlung, bladder, cervical, colorectal, endometrial, ovarian, salivary<br \/>\ngland and pancreatic cancers, HER2 testing is not routinely<br \/>\nperformed for these additional tumour types and prior to this<br \/>\napproval there were no HER2-directed treatments approved in the EU<br \/>\nto treat a broad range of solid tumours.2,3,7,<\/p>\n<p>\u00a0<\/p>\n<p>DESTINY-PanTumor02<\/p>\n<p>DESTINY-PanTumor02 is a global, multicentre, multi-cohort,<br \/>\nopen-label, Phase II trial evaluating the efficacy and safety<br \/>\nof\u00a0Enhertu\u00a0(5.4mg\/kg) for the treatment of previously<br \/>\ntreated HER2-expressing tumours, including biliary tract, bladder,<br \/>\ncervical, endometrial, ovarian, pancreatic cancer or other<br \/>\ntumours.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>The primary endpoint of DESTINY-PanTumor02 is confirmed ORR as<br \/>\nassessed by investigator. Secondary endpoints include DOR, disease<br \/>\ncontrol rate (DCR), progression-free survival (PFS), overall<br \/>\nsurvival (OS), safety, tolerability and pharmacokinetics. Results<br \/>\nfrom DESTINY-PanTumor02 were published in<br \/>\nthe\u00a0Journal<br \/>\nof Clinical Oncology.8<\/p>\n<p>\u00a0<\/p>\n<p>DESTINY-PanTumor02 enrolled 267 HER2-positive (IHC 3+ [n=111] and<br \/>\nIHC 2+ [n=156]) adult patients at multiple sites in Asia, Europe,<br \/>\nNorth America, South America and Oceania. For more information<br \/>\nabout the trial, visit\u00a0ClinicalTrials.gov.<\/p>\n<p>\u00a0<\/p>\n<p>DESTINY-Lung01<\/p>\n<p>DESTINY-Lung01 is a global, open-label, two-cohort, Phase II trial<br \/>\nevaluating the efficacy and safety of\u00a0Enhertu\u00a0(5.4mg\/kg or 6.4mg\/kg) in patients<br \/>\nwith\u00a0HER2-mutant or HER2-overexpressing unresectable or<br \/>\nmetastatic NSCLC who had progressed after one or more systemic<br \/>\ntherapies.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>The primary endpoint of DESTINY-Lung01 is confirmed ORR by<br \/>\nindependent central review. Key secondary endpoints include DOR,<br \/>\nDCR, PFS, OS and safety. Results from the\u00a0HER2-mutant cohort were published<br \/>\nin\u00a0The<br \/>\nNew England Journal of Medicine\u00a0and results from the HER2-overexpressing<br \/>\ncohort were published in\u00a0The<br \/>\nLancet Oncology.9,10<\/p>\n<p>\u00a0<\/p>\n<p>DESTINY-Lung01 enrolled 181 adult patients (HER2-mutant [n=91] and<br \/>\nHER2-overexpressing [n=90; IHC 3+, n=17 and IHC 2+, n=73]) at<br \/>\nmultiple sites in Asia, Europe and North America. For more<br \/>\ninformation about the trial, visit\u00a0ClinicalTrials.gov.<\/p>\n<p>\u00a0<\/p>\n<p>DESTINY-CRC02<\/p>\n<p>DESTINY-CRC02 is a global, randomised, two-arm, parallel,<br \/>\nmulticentre, Phase II trial evaluating the efficacy and safety of<br \/>\ntwo doses (5.4mg\/kg or 6.4mg\/kg) of\u00a0Enhertu\u00a0in patients with locally advanced,<br \/>\nunresectable or metastatic HER2-positive (IHC 3+ or IHC 2+)<br \/>\ncolorectal cancer of BRAF wild-type, RAS wild-type or RAS mutant<br \/>\ntumour types previously treated with standard therapy. The trial<br \/>\nwas conducted in two stages. In the first stage, patients (n=80)<br \/>\nwere randomised 1:1 to receive either 5.4mg\/kg or 6.4mg\/kg<br \/>\nof\u00a0Enhertu. In the second stage, additional patients (n=42)<br \/>\nwere enrolled in the 5.4mg\/kg arm.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>The primary endpoint in DESTINY-CRC02 is confirmed ORR as assessed<br \/>\nby blinded independent central review. Secondary endpoints include<br \/>\nDOR, DCR, investigator-assessed confirmed ORR, clinical benefit<br \/>\nratio, PFS, OS and safety. Results from DESTINY-CRC02 were<br \/>\npublished in\u00a0The<br \/>\nLancet Oncology.11<\/p>\n<p>\u00a0<\/p>\n<p>DESTINY-CRC02 enrolled 122 adult patients (including 64 patients<br \/>\nwith IHC 3+ receiving 5.4mg\/kg) at multiple sites in Asia, Europe,<br \/>\nNorth America and Oceania. For more information about the trial,<br \/>\nvisit\u00a0ClinicalTrials.gov.<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu<\/p>\n<p>\u200bEnhertu\u202fis a<br \/>\nHER2-directed ADC. Designed using Daiichi Sankyo&#8217;s<br \/>\nproprietary\u00a0DXd\u00a0ADC Technology,\u202fEnhertu\u202fis<br \/>\nthe lead ADC in the oncology portfolio of Daiichi Sankyo and the<br \/>\nmost advanced programme in AstraZeneca&#8217;s ADC scientific<br \/>\nplatform.\u202fEnhertu\u202fconsists of a HER2 monoclonal antibody<br \/>\nattached to a number of\u00a0topoisomerase\u00a0I inhibitor<br \/>\npayloads (an\u00a0exatecan\u00a0derivative,\u00a0DXd) via<br \/>\ntetrapeptide-based cleavable linkers.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0(5.4mg\/kg) is<br \/>\napproved in the US as an adjuvant treatment for adult patients with<br \/>\nHER2-positive\u00a0(IHC 3+ or<br \/>\nISH+)\u00a0breast<br \/>\ncancer\u00a0who have residual invasive disease following<br \/>\ntrastuzumab (with or without pertuzumab) and taxane-based<br \/>\ntreatment\u00a0based on the\u00a0DESTINY-Breast05\u00a0trial.<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0(5.4mg\/kg)<br \/>\nfollowed by THP is approved in China and the US as a neoadjuvant<br \/>\ntreatment for adult patients with HER2-positive\u00a0(IHC 3+ or<br \/>\nISH+)\u00a0Stage II or Stage III breast cancer based on the results<br \/>\nfrom the\u00a0DESTINY-Breast11\u00a0trial.<br \/>\nContinued approval in China for this indication may be contingent<br \/>\nupon verification and description of clinical benefit in a<br \/>\nconfirmatory trial.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0(5.4mg\/kg)\u00a0in<br \/>\ncombination with pertuzumab is approved in the US, Switzerland,<br \/>\nUnited Arab Emirates, Saudi Arabia, Israel, Brazil and India as a<br \/>\n1st-line treatment for adult patients with unresectable or<br \/>\nmetastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as<br \/>\ndetermined by an FDA-approved test,\u00a0based on the results from<br \/>\nthe\u00a0DESTINY-Breast09\u00a0trial.<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0(5.4mg\/kg) is<br \/>\napproved in more than 95 countries\/regions worldwide for the<br \/>\ntreatment of adult patients with unresectable or metastatic<br \/>\nHER2-positive (IHC 3+ or ISH+) breast cancer who have received a<br \/>\nprior anti-HER2-based regimen, either in the metastatic setting or<br \/>\nin the neoadjuvant or adjuvant setting, and have developed disease<br \/>\nrecurrence during or within six months of completing therapy based<br \/>\non the results from the\u00a0DESTINY-Breast03\u00a0trial.<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0(5.4mg\/kg) is<br \/>\napproved in more than 95 countries\/regions worldwide for the<br \/>\ntreatment of adult patients with unresectable or metastatic<br \/>\nHER2-low (IHC 1+ or IHC 2+\/ISH-) breast cancer who have received a<br \/>\nprior systemic therapy in the metastatic setting or developed<br \/>\ndisease recurrence during or within six months of completing<br \/>\nadjuvant chemotherapy based on the results from<br \/>\nthe\u00a0DESTINY-Breast04\u00a0trial.<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0(5.4mg\/kg) is<br \/>\napproved in more than 70 countries\/regions worldwide for the<br \/>\ntreatment of adult patients with unresectable or metastatic hormone<br \/>\nreceptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+\/ ISH-) or<br \/>\nHER2-ultralow (IHC 0 with membrane staining) breast cancer, as<br \/>\ndetermined by a locally or regionally approved test, that have<br \/>\nprogressed on one or more endocrine therapies in the metastatic<br \/>\nsetting based on the results from the\u00a0DESTINY-Breast06\u00a0trial.<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0(5.4mg\/kg) is<br \/>\napproved in more than 75 countries\/regions worldwide for the<br \/>\ntreatment of adult patients with unresectable or metastatic NSCLC<br \/>\nwhose tumours have activating\u00a0HER2\u00a0(ERBB2) mutations, as detected by a locally or<br \/>\nregionally approved test, and who have received a prior systemic<br \/>\ntherapy based on the results from the\u00a0DESTINY-Lung02\u00a0and\/or\u00a0DESTINY-Lung05\u00a0trials.<br \/>\nContinued approval in China and the US for this indication may be<br \/>\ncontingent upon verification and description of clinical benefit in<br \/>\na confirmatory trial.<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0(6.4mg\/kg) is<br \/>\napproved in more than 90 countries\/regions worldwide for the<br \/>\ntreatment of adult patients with locally advanced or metastatic<br \/>\nHER2-positive (IHC 3+ or IHC 2+\/ISH+) gastric or gastroesophageal<br \/>\njunction (GEJ) adenocarcinoma who have received a prior<br \/>\ntrastuzumab-based regimen based on the results from<br \/>\nthe\u00a0DESTINY-Gastric01,\u00a0DESTINY-Gastric02\u00a0and\/or\u00a0DESTINY-Gastric04\u00a0trials.<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0(5.4mg\/kg) is<br \/>\napproved in more than\u00a040\u00a0countries\/regions worldwide for<br \/>\nthe treatment of adult patients with unresectable or metastatic<br \/>\nHER2-positive (IHC 3+) solid tumours who have received prior<br \/>\nsystemic treatment and\/or have no satisfactory alternative<br \/>\ntreatment options based on efficacy results from<br \/>\nthe\u00a0DESTINY-PanTumor02,\u00a0DESTINY-Lung01,\u00a0DESTINY-CRC02\u00a0and\/or\u00a0HERALD\u00a0trials.\u00a0trials.<br \/>\nContinued approval\u00a0in the US\u00a0for<br \/>\nthis\u00a0indication\u00a0may be contingent upon verification and<br \/>\ndescription of clinical benefit in a confirmatory<br \/>\ntrial.<\/p>\n<p>\u00a0<\/p>\n<p>Enhertu\u00a0clinical development<br \/>\nprogramme\u00a0<\/p>\n<p>A comprehensive global clinical development programme is underway<br \/>\nevaluating the efficacy and safety of\u00a0Enhertu\u00a0as a monotherapy, in combination or<br \/>\nsequentially with other cancer medicines across multiple<br \/>\nHER2-targetable cancers.\u00a0\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\u200bDaiichi Sankyo collaboration\u00a0<\/p>\n<p>AstraZeneca and Daiichi Sankyo\u00a0entered into\u00a0a global<br \/>\ncollaboration to jointly develop and<br \/>\ncommercialise\u202fEnhertu\u202fin\u202fMarch<br \/>\n2019\u202fand\u202fDatroway\u202f(datopotamab\u00a0deruxtecan)<br \/>\nin\u202fJuly<br \/>\n2020, except<br \/>\nin Japan where Daiichi Sankyo\u00a0maintains\u00a0exclusive rights<br \/>\nfor each ADC. Daiichi Sankyo\u00a0is responsible for\u00a0the<br \/>\nmanufacturing and supply of\u202fEnhertu\u202fand\u202fDatroway.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca in oncology\u00a0<\/p>\n<p>AstraZeneca is leading a revolution in oncology with the ambition<br \/>\nto provide cures for cancer in every form, following the science<br \/>\nto\u00a0understand\u00a0cancer and all its complexities to<br \/>\ndiscover, develop and deliver life-changing medicines to<br \/>\npatients.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>The Company&#8217;s focus is on some of the most challenging cancers. It<br \/>\nis through persistent innovation that AstraZeneca has built one of<br \/>\nthe most diverse portfolios and pipelines in the industry, with the<br \/>\npotential to catalyse changes in the practice of medicine and<br \/>\ntransform the patient experience.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca has the vision to redefine cancer care and, one<br \/>\nday,\u00a0eliminate\u00a0cancer as a cause of<br \/>\ndeath.\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>AstraZeneca<\/p>\n<p>AstraZeneca (LSE\/STO\/NYSE: AZN) is a global, science-led<br \/>\nbiopharmaceutical company that focuses on the discovery,<br \/>\ndevelopment, and commercialisation of prescription medicines in<br \/>\nOncology, Rare Disease, and BioPharmaceuticals, including<br \/>\nCardiovascular, Renal &amp; Metabolism, and Respiratory &amp;<br \/>\nImmunology. Based in Cambridge, UK, AstraZeneca&#8217;s innovative<br \/>\nmedicines are sold in more than 125 countries and used by millions<br \/>\nof patients worldwide. Please visit\u00a0astrazeneca.com\u00a0and<br \/>\nfollow the Company on Social Media\u00a0@AstraZeneca.<\/p>\n<p>\u00a0<\/p>\n<p>Contacts<\/p>\n<p>For details on how to contact the Investor Relations Team, please<br \/>\nclick\u00a0here.<br \/>\nFor Media contacts, click\u00a0here.<\/p>\n<p>\u00a0<\/p>\n<p>References<\/p>\n<p>\n1.\u00a0\u00a0\u00a0Iqbal N, Iqbal N. Human<br \/>\nEpidermal Growth Factor Receptor 2 (HER2) in Cancers:<br \/>\nOverexpression and Therapeutic<br \/>\nImplications.\u00a0Mol<br \/>\nBiol Int.<br \/>\n2014;2014:852748.<\/p>\n<p>\n2.\u00a0\u00a0 Cheng X. A comprehensive review of<br \/>\nHER2 in cancer biology and therapeutics.\u00a0Genes\u00a0(Basel).\u00a02024;15(7):903.<\/p>\n<p>\n3.\u00a0\u00a0\u00a0Ismail A, et al. HER2<br \/>\nalterations across solid tumour: implications for comprehensive<br \/>\ntesting.\u00a0Oncologist.\u00a02025;30(9):258.<\/p>\n<p>\n4.\u00a0\u00a0\u00a0Benli Y, et al.<br \/>\nHER2-targeted therapy in colorectal cancer: a comprehensive<br \/>\nreview.\u00a0Clin<br \/>\nTransl Oncol.<br \/>\n2025;27(9):3607-3624.<\/p>\n<p>\n5.\u00a0\u00a0\u00a0Uy NF, et al. HER2 in<br \/>\nnon-small cell lung cancer: a review of emerging<br \/>\ntherapies.\u00a0Cancers\u00a0(Basel).<br \/>\n2022;14(17):4155.<\/p>\n<p>\n6.\u00a0\u00a0\u00a0Haigh JE, et al. The<br \/>\nclinical utilisation and duration of treatment with HER2-directed<br \/>\ntherapies in HER2-positive recurrent or metastatic salivary gland<br \/>\ncancers.\u00a0Curr<br \/>\nOncol.\u00a02024;31(9):5652-5661.<\/p>\n<p>\n7.\u00a0\u00a0\u00a0Omar N, et al. HER2: An<br \/>\nemerging biomarker in non-breast and non-gastric<br \/>\ncancers.\u00a0Pathogenesis.<br \/>\n2015;2(3):1-9.<\/p>\n<p>\n8.\u00a0\u00a0\u00a0Meric-Bernstam F, et<br \/>\nal.\u00a0Efficacy and Safety of<br \/>\nTrastuzumab Deruxtecan in Patients With HER2-Expressing Solid<br \/>\nTumour: Primary Results From the DESTINY-PanTumor02 Phase II<br \/>\nTrial.\u00a0J<br \/>\nClin Oncol.<br \/>\n2023;42(1):47-58.<\/p>\n<p>\n9.\u00a0\u00a0 Li B, et al. Trastuzumab Deruxtecan<br \/>\nin HER2-Mutant Non-Small-Cell Lung Cancer.\u00a0N<br \/>\nEngl J Med.\u00a02022;386:241-251.<\/p>\n<p>\n10.\u00a0 Smit E, et al. Trastuzumab deruxtecan in<br \/>\npatients with metastatic non-small-cell lung cancer<br \/>\n(DESTINY-Lung01): primary results of the HER2-overexpressing<br \/>\ncohorts from a single-arm, phase 2 trial.\u00a0Lancet<br \/>\nOncol.<br \/>\n2024;25(4):439-454.<\/p>\n<p>\n11.\u00a0 Raghav K, et al. Trastuzumab deruxtecan<br \/>\nin patients with HER2-positive advanced colorectal cancer<br \/>\n(DESTINY-CRC02): primary results from a multicentre, randomised,<br \/>\nphase 2 trial.\u00a0Lancet<br \/>\nOncol.<br \/>\n2024;25(9):1147-1162.<\/p>\n<p>\u00a0<\/p>\n<p>Matthew Bowden<\/p>\n<p>Company Secretary<\/p>\n<p>AstraZeneca PLC<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>SIGNATURES<\/p>\n<p>\u00a0<\/p>\n<p>\nPursuant<br \/>\nto the requirements of the Securities Exchange Act of 1934, the<br \/>\nRegistrant has duly caused this report to be signed on its behalf<br \/>\nby the undersigned, thereunto duly authorized.<\/p>\n<p>\u00a0<\/p>\n<p>\n\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>Date: 29 June 2026<\/p>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p>\nBy: \/s\/<br \/>\nMatthew Bowden<\/p>\n<p>\u00a0<\/p>\n<p>\nName:<br \/>\nMatthew Bowden<\/p>\n<p>\u00a0<\/p>\n<p>\nTitle:<br \/>\nCompany Secretary<\/p>\n<p>\n\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"FORM 6-K \u00a0 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 \u00a0 \u00a0 Report of Foreign Issuer \u00a0 Pursuant&hellip;\n","protected":false},"author":2,"featured_media":72847,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[20662],"tags":[24358,11153,21721,23044,33165,33198,12166,33199],"class_list":["post-72846","post","type-post","status-publish","format-standard","has-post-thumbnail","category-astrazeneca","tag-antibody-drug-conjugate","tag-astrazeneca","tag-azn","tag-daiichi-sankyo","tag-destiny-pantumor02","tag-enhertu-eu-approval","tag-oncology","tag-tumour-agnostic-her2-therapy"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@UnitedKingdom\/116834858690574107","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/72846","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/comments?post=72846"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/72846\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media\/72847"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/media?parent=72846"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/categories?post=72846"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/tags?post=72846"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}