FORM 6-K<\/p>\n
\u00a0<\/p>\n
\nSECURITIES
\nAND EXCHANGE COMMISSION<\/p>\n
\nWashington,
\nD.C. 20549<\/p>\n
\n\u00a0<\/p>\n
\u00a0<\/p>\n
\nReport
\nof Foreign Issuer<\/p>\n
\u00a0<\/p>\n
\nPursuant
\nto Rule 13a-16 or 15d-16 of<\/p>\n
\nthe
\nSecurities Exchange Act of 1934<\/p>\n
\n\u00a0<\/p>\n
\nFor the
\nmonth of July 2026\u00a0<\/p>\n
\n\u00a0<\/p>\n
\nCommission
\nFile Number: 001-11960<\/p>\n
\n\u00a0<\/p>\n
AstraZeneca PLC<\/p>\n
\n\u00a0<\/p>\n
\n1
\nFrancis Crick Avenue<\/p>\n
\nCambridge
\nBiomedical Campus<\/p>\n
\nCambridge
\nCB2 0AA<\/p>\n
\nUnited
\nKingdom<\/p>\n
\n\u00a0<\/p>\n
\u00a0<\/p>\n
\nIndicate
\nby check mark whether the registrant files or will file annual
\nreports under cover of Form 20-F or Form 40-F.<\/p>\n
\u00a0<\/p>\n
\nForm
\n20-F X Form 40-F __<\/p>\n
\u00a0<\/p>\n
\nIndicate
\nby check mark if the registrant is submitting the Form 6-K in paper
\nas permitted by Regulation S-T Rule 101(b)(1):<\/p>\n
\u00a0<\/p>\n
\nIndicate
\nby check mark if the registrant is submitting the Form 6-K in paper
\nas permitted by Regulation S-T Rule 101(b)(7): ______<\/p>\n
\u00a0<\/p>\n
\nIndicate
\nby check mark whether the registrant by furnishing the information
\ncontained in this Form is also thereby furnishing the information
\nto the Commission pursuant to Rule 12g3-2(b) under the Securities
\nExchange Act of 1934.<\/p>\n
\u00a0<\/p>\n
\nYes __
\nNo X<\/p>\n
\u00a0<\/p>\n
\nIf
\n\u201cYes\u201d is marked, indicate below the file number
\nassigned to the Registrant in connection with Rule 12g3-2(b):
\n82-_____________<\/p>\n
\u00a0<\/p>\n
\n\u00a0<\/p>\n
\u00a0<\/p>\n
\n\u00a0<\/p>\n
\u00a0<\/p>\n
AstraZeneca PLC<\/p>\n
\n\u00a0<\/p>\n
\nINDEX
\nTO EXHIBITS<\/p>\n
\n\u00a0<\/p>\n
\u00a0<\/p>\n
\n1.<\/p>\n
Sone-Ve improved survival in gastric
\ncancers<\/p>\n
\n\u00a0<\/p>\n
\u00a0<\/p>\n
\u00a027 July
\n2026<\/p>\n
\u00a0<\/p>\n
Sonesitatug vedotin demonstrated a statistically significant and
\nhighly clinically meaningful improvement in overall survival in 2nd
\nand later-line CLDN18.2-positive advanced gastric\/GEJ
\ncancers<\/p>\n
\u00a0<\/p>\n
Results provide opportunity to expand CLDN18.2 positivity to
\n\u226525% expression, representing approximately 60% of patients
\nin this setting<\/p>\n
\u00a0<\/p>\n
CLARITY-Gastric01 is the first Phase III trial to show overall
\nsurvival benefit with an anti-CLDN18.2 ADC in this
\nsetting<\/p>\n
\u00a0<\/p>\n
First pivotal readout from AstraZeneca’s wholly owned ADC
\nportfolio<\/p>\n
\u00a0<\/p>\n
Positive high-level results from the CLARITY-Gastric01 global Phase
\nIII trial showed that sonesitatug vedotin (Sone-Ve) demonstrated a
\nstatistically significant and highly clinically meaningful
\nimprovement in overall survival (OS) in 2nd and later-line Claudin
\n18.2-positive advanced gastric cancers versus investigator’s choice
\nof therapy. The trial included patients with locally advanced or
\nmetastatic gastric cancer, gastroesophageal junction (GEJ) cancer,
\nor oesophageal adenocarcinoma (EAC) with Claudin 18.2 (CLDN18.2)
\nexpression on at least 25% of tumour cells at any staining
\nintensity.<\/p>\n
\u00a0<\/p>\n
The trial had dual primary endpoints of OS in 3rd\u00a0and
\nlater-line treatment and progression-free survival (PFS) in the
\noverall trial population. The trial met the dual primary endpoint
\nof OS in 3rd and later-line treatment, and a key secondary endpoint
\nof OS in the overall trial population of patients treated in the
\n2nd and later-line setting, demonstrating a statistically
\nsignificant and highly clinically meaningful
\nimprovement.<\/p>\n
\u00a0<\/p>\n
For the other dual primary endpoint of PFS as assessed by blinded
\nindependent central review (BICR), results showed a trend toward
\nimproved PFS in patients treated in the 2nd and later-line setting
\nbut did not reach statistical significance.<\/p>\n
\u00a0<\/p>\n
The majority of patients with gastric\/GEJ cancers are diagnosed at
\nan advanced or metastatic stage, where the prognosis is especially
\npoor and treatment options are limited, with less than 20%
\nsurviving more than one year.1,2\u00a0CLDN18.2
\nhas emerged as an important therapeutic target for these patients,
\nwith an estimated 60% of gastric\/GEJ cancers expressing CLDN18.2 in
\n25% or more of tumour cells.3\u00a0Each
\nyear, there are roughly 183,500 patients in the US, EU, China and
\nJapan treated in the 2nd and later-line setting for advanced or
\nmetastatic CLDN18.2-positive, non-HER2-positive gastric\/GEJ
\ncancers.4<\/p>\n
\u00a0<\/p>\n
Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical
\nOncology, Sun Yat-Sen University Cancer Center, Guangzhou, China,
\nand principal investigator of the trial said: “Metastatic gastric
\ncancer is an aggressive disease with very limited options once
\npatients progress after first-line treatment. Sone-Ve is the first
\nCLDN18.2-targeted antibody drug conjugate to demonstrate an overall
\nsurvival benefit in this setting and has the potential to establish
\na new precision treatment for a broader population of patients with
\nCLDN18.2 expression.”<\/p>\n
\u00a0<\/p>\n
Susan Galbraith, Executive Vice President, Oncology Haematology
\nR&D, said: “Sone-Ve has the potential to reshape the treatment
\nof gastric cancer by replacing classic chemotherapy with this novel
\ntargeted antibody drug conjugate to improve outcomes for patients.
\nThese transformative results from the first Phase
\nIII\u00a0readout
\nfor Sone-Ve, together with our broad development programme,
\nhighlight the potential for Sone-Ve to become an important new
\nmedicine in CLDN18.2-positive cancers.”<\/p>\n
\u00a0<\/p>\n
Sone-Ve was well tolerated, and its profile was consistent with the
\nknown safety profile of Sone-Ve with no new safety signals
\nidentified.<\/p>\n
\u00a0<\/p>\n
Sone-Ve\u00a0is
\na potential global first-in-class CLDN18.2-targeting antibody drug
\nconjugate (ADC) with a monomethyl auristatin E (MMAE)
\npayload.<\/p>\n
\u00a0<\/p>\n
These data will be presented at a forthcoming medical meeting and
\nshared with global regulatory authorities.<\/p>\n
\u00a0<\/p>\n
Sone-Ve has received Orphan Drug Designation from the US Food and
\nDrug Administration and the European Commission for the treatment
\nof gastric and GEJ cancers. It has also received Breakthrough
\nDesignation in China for the 2nd-line treatment of gastric
\ncancer.<\/p>\n
\u00a0<\/p>\n
Notes<\/p>\n
\u00a0<\/p>\n
Gastric and GEJ cancers<\/p>\n
Gastric (stomach) cancer is the fifth most common cancer worldwide
\nand the fifth-leading cause of cancer-related
\ndeath.5\u00a0Nearly
\none million new patients were diagnosed with gastric cancer in
\n2024, with approximately 650,000 deaths reported globally. In many
\nregions, its incidence has been increasing in patients younger than
\n50 years old, along with other gastrointestinal (GI)
\nmalignancies.5<\/p>\n
\u00a0<\/p>\n
GEJ cancer is a type of gastric cancer that arises from and spans
\nthe area where the oesophagus connects to the
\nstomach.6<\/p>\n
\u00a0<\/p>\n
Most advanced gastric cancer patients will eventually experience
\ndisease progression after standard 1st-line therapies, and
\nsubsequent lines yield poor outcomes, with median survival of 5-9
\nmonths for patients receiving 2nd and later-line systemic
\ntreatments.7-9<\/p>\n
\u00a0<\/p>\n
CLARITY-Gastric01<\/p>\n
CLARITY-Gastric01 is a randomised, open-label, sponsor-blinded,
\nmulticentre, global Phase III trial evaluating Sone-Ve as a 2nd and
\nlater-line therapy for patients with advanced or metastatic gastric
\ncancer, GEJ cancer, or EAC with\u00a0CLDN18.2
\nexpression\u00a0in
\n25% or more of tumour cells, with IHC+ of any intensity. In the
\ntrial, patients were randomised 1:1:1 in Stage 1 (dose selection)
\nto Sone-Ve monotherapy 2.2 mg\/kg or 1.8 mg\/kg every three weeks, or
\ninvestigator’s choice of therapy, the comparator arm. In Stage 2,
\nthe trial continued with Sone-Ve 2.2 mg\/kg as the recommended Phase
\nIII dose.<\/p>\n
\u00a0<\/p>\n
The efficacy analyses from this study will also provide the basis
\nto evaluate the clinical performance of the Ventana SP455 assay for
\nthe identification of patients with advanced or metastatic gastric,
\nGEJ or EAC cancers expressing CLDN18.2 who may benefit
\nfrom\u00a0Sone-Ve.<\/p>\n
\u00a0<\/p>\n
The trial is being conducted in 175 centres across 19 countries,
\nincluding in North America, Europe, South America and Asia. Its
\ndual primary endpoints are PFS as assessed by BICR in the 2nd and
\nlater-line setting and OS in the 3rd and later-line setting. A key
\nsecondary endpoint is OS in the 2nd and later-line
\nsetting.<\/p>\n
\u00a0<\/p>\n
Sonesitatug Vedotin (Sone-Ve)<\/p>\n
Sone-Ve is a novel ADC targeting\u00a0CLDN18.2,
\na protein found in the stomach lining and a validated therapeutic
\ntarget in oncology, particularly for GI cancers. Sone-Ve consists
\nof an anti-CLDN18.2 monoclonal antibody, a protease-degradable
\nlinker and a cytotoxic small molecule MMAE
\npayload.<\/p>\n
\u00a0<\/p>\n
AstraZeneca entered into a global exclusive licence agreement with
\nKYM Biosciences to develop and commercialise Sone-Ve
\nin\u00a0March
\n2023.<\/p>\n
\u00a0<\/p>\n
In addition to CLARITY-Gastric01, Sone-Ve is being evaluated in the
\nCLARITY-Gastric02 Phase III trial in combination with capecitabine,
\nwith or without rilvegostomig, as a 1st-line treatment for advanced
\nor metastatic gastric cancer, GEJ cancer and EAC. In Phase II
\ndevelopment, Sone-Ve is being evaluated in patients with advanced
\nsolid tumours in multiple combinations across settings, including
\nin CLDN18.2-positive pancreatic and biliary tract cancers
\n(BTC).<\/p>\n
\u00a0<\/p>\n
AstraZeneca in GI cancers<\/p>\n
AstraZeneca has a broad development programme for the treatment of
\nGI cancers across several medicines and a variety of tumour types
\nand stages of disease. In 2024, GI cancers collectively represented
\napproximately 5 million new cancer cases leading to approximately
\n3.3 million deaths.10<\/p>\n
\u00a0<\/p>\n
Within this programme, the Company is committed to improving
\noutcomes in gastric, liver, biliary tract, oesophageal, pancreatic
\nand colorectal cancers.<\/p>\n
\u00a0<\/p>\n
Imfinzi\u00a0(durvalumab),
\nan anti-PDL1 antibody, is approved in the US, China, EU, Japan and
\nother countries in combination with chemotherapy in locally
\nadvanced or metastatic BTC, in combination
\nwith\u00a0Imjudo\u00a0(tremelimumab) in
\nunresectable\u00a0hepatocellular
\ncarcinoma (HCC) and in combination with FLOT chemotherapy
\n(fluorouracil, leucovorin, oxaliplatin, and docetaxel) in
\nearly-stage and locally advanced gastric and GEJ
\ncancers.\u00a0Imfinzi\u00a0is
\nalso approved as a monotherapy in unresectable HCC in Japan, China
\nand the EU.<\/p>\n
\u00a0<\/p>\n
Enhertu\u00a0(trastuzumab
\nderuxtecan), a HER2-directed ADC is approved in the US, China, EU,
\nJapan and several other countries for HER2-positive advanced
\ngastric cancer.\u00a0Enhertu\u00a0is jointly developed and commercialised by
\nAstraZeneca and Daiichi Sankyo.<\/p>\n
\u00a0<\/p>\n
Lynparza\u00a0(olaparib),
\na first-in-class PARP inhibitor, is approved in the US and several
\nother countries for the treatment of BRCA-mutated metastatic
\npancreatic cancer.\u00a0Lynparza\u00a0is developed and commercialised in
\ncollaboration with MSD (Merck & Co., Inc. inside the US and
\nCanada).<\/p>\n
\u00a0<\/p>\n
Orpathys\u00a0(savolitinib),
\nan oral, potent, and highly selective MET tyrosine kinase inhibitor
\n(TKI), has received conditional approval in China for the treatment
\nof patients with locally advanced or metastatic gastric cancer or
\nGEJ adenocarcinoma harbouring MET amplification who have progressed
\non at least two prior lines of systemic
\ntherapy.\u00a0Orpathys\u00a0is being jointly developed and
\ncommercialised by AstraZeneca and HUTCHMED.<\/p>\n
\u00a0<\/p>\n
The Company is also assessing rilvegostomig, a PD-1\/TIGIT
\nbispecific antibody, in combination with chemotherapy as an
\nadjuvant therapy in BTC, and in combination
\nwith\u00a0Enhertu\u00a0in previously untreated, HER2-expressing,
\nlocally advanced or metastatic BTC. Rilvegostomig is also being
\nevaluated in combination with bevacizumab with or
\nwithout\u00a0Imjudo\u00a0as a 1st-line treatment in patients with
\nadvanced HCC, and as a 1st-line combination treatment in patients
\nwith HER2-positive, or CLDN18.2-positive and HER2-negative, locally
\nadvanced unresectable or metastatic gastric and GEJ
\ncancers.<\/p>\n
\u00a0<\/p>\n
In addition to Sone-Ve, AstraZeneca is also
\nadvancing\u00a0AZD5863,
\na novel\u00a0CLDN18.2\/CD3
\nT-cell engager bispecific antibody licensed from Harbour Biomed in
\nPhase I development.<\/p>\n
\u00a0<\/p>\n
In early development, AstraZeneca is developing AZD7003, a Glypican
\n3 armoured CAR T, in HCC. The Company is also advancing a pan-KRAS
\ninhibitor programme licensed from Jacobio Pharma, which is being
\nevaluated in Phase I trials in advanced solid tumours with KRAS
\nalterations, including in pancreatic ductal
\nadenocarcinoma.<\/p>\n
\u00a0<\/p>\n
AstraZeneca in oncology<\/p>\n
AstraZeneca is leading a revolution in oncology with the ambition
\nto provide cures for cancer in every form, following the science to
\nunderstand cancer and all its complexities to discover, develop and
\ndeliver life-changing medicines to patients.<\/p>\n
\u00a0<\/p>\n
The Company’s focus is on some of the most challenging cancers. It
\nis through persistent innovation that AstraZeneca has built one of
\nthe most diverse portfolios and pipelines in the industry, with the
\npotential to catalyse changes in the practice of medicine and
\ntransform the patient experience.<\/p>\n
\u00a0<\/p>\n
AstraZeneca has the vision to redefine cancer care and, one day,
\neliminate cancer as a cause of death.<\/p>\n
\u00a0<\/p>\n
AstraZeneca<\/p>\n
AstraZeneca (LSE\/STO\/NYSE: AZN) is a global, science-led
\nbiopharmaceutical company that focuses on the discovery,
\ndevelopment, and commercialisation of prescription medicines in
\nOncology, Rare Disease, and BioPharmaceuticals, including
\nCardiovascular, Renal & Metabolism, and Respiratory &
\nImmunology. Based in Cambridge, UK, AstraZeneca’s innovative
\nmedicines are sold in more than 125 countries and used by millions
\nof patients worldwide. Please visit\u00a0astrazeneca.com\u00a0and
\nfollow the Company on Social Media\u00a0@AstraZeneca.<\/p>\n
\u00a0<\/p>\n
Contacts<\/p>\n
For details on how to contact the Investor Relations Team, please
\nclick\u00a0here.
\nFor Media contacts, click\u00a0here.<\/p>\n
\u00a0<\/p>\n
References\u00a0<\/p>\n
\u00a0<\/p>\n
\n1.\u00a0\u00a0\u00a0Davis
\nJA, et al. Treatment heterogeneity and overall survival in patients
\nwith advanced\/metastatic gastric or gastroesophageal junction
\nadenocarcinoma in the United States.\u00a0J\u00a0Gastrointest\u00a0Oncol.
\n2022 Jun;13(3):949-957.\u00a0\u00a0<\/p>\n
\n2.\u00a0\u00a0\u00a0Cancer
\nResearch UK.\u00a0Survival for stomach
\ncancer.\u00a0https:\/\/www.cancerresearchuk.org\/about-cancer\/stomach-cancer\/survival.
\nAccessed July 2026.\u00a0\u00a0<\/p>\n
\n3.\u00a0\u00a0\u00a0Poniewierska-Baran
\nA,\u00a0et al.\u00a0Claudin18.2
\nas a Promising Therapeutic Target in Gastric
\nCancer.\u00a0Cells.\u00a02025;14(16):1285.\u00a0\u00a0<\/p>\n
\n4.\u00a0\u00a0\u00a0AstraZeneca
\nPLC. Investor Relations Epidemiology Spreadsheet. Top 8 Countries.
\nAvailable at: https:\/\/www.astrazeneca.com\/investor-relations.html.
\nAccessed July 2026.\u00a0<\/p>\n
\n5.\u00a0\u00a0\u00a0World
\nHealth Organization. International Agency for Research on Cancer.
\nStomach Fact Sheet. Available
\nat:\u00a0https:\/\/gco.iarc.who.int\/today\/en\/fact-sheets-cancers\/7\/stomach.\u00a0Accessed\u00a0July
\n2026.\u00a0\u00a0<\/p>\n
\n6.\u00a0\u00a0\u00a0National
\nCancer Institute. Gastroesophageal junction. Available at:
\nhttps:\/\/www.cancer.gov\/publications\/dictionaries\/cancer-terms\/def\/gastroesophageal-junction.
\nAccessed\u00a0July\u00a02026.\u00a0<\/p>\n
\n7.\u00a0\u00a0\u00a0Abderhalden\u00a0LA,\u00a0et
\nal.\u00a0Clinical Outcomes for Previously Treated Patients with
\nAdvanced Gastric or Gastroesophageal Junction Cancer: A Systematic
\nLiterature Review and Meta-Analysis.\u00a0J\u00a0Gastrointest\u00a0Cancer.\u00a02023;54(4):1031-1045.\u00a0<\/p>\n
\n8.\u00a0\u00a0\u00a0Ford
\nHE, et al. Docetaxel versus active symptom control for refractory
\noesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3
\nrandomised controlled trial.\u00a0\u2060The
\nLancet Oncology, 2014;15(1),
\n78-86.<\/p>\n
\n9.\u00a0\u00a0 Wilke H, et al. Ramucirumab plus
\npaclitaxel versus placebo plus paclitaxel in patients with
\npreviously treated advanced gastric or gastro-oesophageal junction
\nadenocarcinoma (RAINBOW): a randomised, multicentre, double-blind,
\nphase 3 trial.\u00a0\u2060The
\nLancet Oncology, 2014;15(11),
\n1224-1235.<\/p>\n
\n10.\u00a0\u00a0World
\nHealth Organization. World Cancer Fact Sheet. Available
\nat\u00a0https:\/\/gco.iarc.who.int\/today\/en\/fact-sheets-populations\/900\/world.\u00a0Accessed
\nJuly 2026.\u00a0<\/p>\n
\u00a0<\/p>\n
Matthew Bowden<\/p>\n
Company Secretary<\/p>\n
AstraZeneca PLC<\/p>\n
\u00a0<\/p>\n
\n\u00a0<\/p>\n
SIGNATURES<\/p>\n
\u00a0<\/p>\n
\nPursuant
\nto the requirements of the Securities Exchange Act of 1934, the
\nRegistrant has duly caused this report to be signed on its behalf
\nby the undersigned, thereunto duly authorized.<\/p>\n
\u00a0<\/p>\n
\n\u00a0<\/p>\n
\u00a0<\/p>\n
Date: 27 July 2026<\/p>\n
\u00a0<\/p>\n
\u00a0<\/p>\n
\nBy: \/s\/
\nMatthew Bowden<\/p>\n
\u00a0<\/p>\n
\nName:
\nMatthew Bowden<\/p>\n
\u00a0<\/p>\n
\nTitle:
\nCompany Secretary<\/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…\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":[24358,11153,21721,39151,39148,39150,39149,32351,36189,39147],"class_list":["post-91636","post","type-post","status-publish","format-standard","has-post-thumbnail","category-astrazeneca","tag-antibody-drug-conjugate","tag-astrazeneca","tag-azn","tag-breakthrough-designation","tag-clarity-gastric01","tag-cldn18-2","tag-gastric-cancer","tag-orphan-drug-designation","tag-overall-survival","tag-sone-ve"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@UnitedKingdom\/116995310656370457","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/91636","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=91636"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/posts\/91636\/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=91636"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/categories?post=91636"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/britain\/wp-json\/wp\/v2\/tags?post=91636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}