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
\n\u00a0<\/p>\n
AstraZeneca PLC<\/p>\n
\n\u00a0<\/p>\n
\nINDEX
\nTO EXHIBITS<\/p>\n
\n\u00a0<\/p>\n
\u00a0<\/p>\n
1.<\/p>\n
\nEtcamah approved in the EU for ER+ breast cancer\u00a0<\/p>\n
\n\u00a0<\/p>\n
\u00a0<\/p>\n
23 July 2026<\/p>\n
\nEtcamah\u00a0(camizestrant)
\nin combination with a CDK4\/6 inhibitor\u00a0approved in the EU for
\n1st-line advanced ER-positive breast
\ncancer<\/p>\n
\u00a0<\/p>\n
Approval based on SERENA-6 Phase III trial results which showed
\ncombination reduced the risk of disease progression or death by 56%
\nin patients with an emergent ESR1 tumour mutation<\/p>\n
\u00a0<\/p>\n
First and only next-generation oral SERD and complete ER antagonist
\napproved in 1st-line and only option in combination with all widely
\napproved CDK4\/6 inhibitors<\/p>\n
\u00a0<\/p>\n
Etcamah\u00a0is
\n11th new AstraZeneca medicine of the 20 expected to launch by
\n2030<\/p>\n
\u00a0<\/p>\n
AstraZeneca’s\u00a0Etcamah\u00a0(camizestrant) in\u00a0combination with a
\ncyclin-dependent kinase (CDK) 4\/6 inhibitor (palbociclib,
\nribociclib or abemaciclib)\u00a0has been approved in the European
\nUnion (EU) for the treatment of adult patients with estrogen
\nreceptor (ER)-positive, HER2-negative locally advanced or
\nmetastatic breast cancer upon detection of\u00a0ESR1\u00a0mutation and without disease progression
\nduring 1st-line endocrine therapy in combination with a CDK4\/6
\ninhibitor.<\/p>\n
\u00a0<\/p>\n
The approval by the European Commission follows
\nthe\u00a0positive
\nopinion\u00a0of the Committee
\nfor Medicinal Products for Human Use and was based on the positive
\nresults from the pivotal\u00a0SERENA-6 Phase III trial published
\nin\u00a0The
\nNew England Journal of Medicine.1<\/p>\n
\u00a0<\/p>\n
In a planned interim analysis, the\u00a0Etcamah\u00a0combination reduced the risk of disease
\nprogression or death by 56% versus standard-of-care treatment with
\nan aromatase inhibitor (AI) (anastrozole or letrozole) in
\ncombination with a CDK4\/6 inhibitor (based on a hazard ratio [HR]
\nof 0.44; 95% confidence interval [CI]:0.31-0.60; p<0.00001;
\nmedian progression-free survival (PFS) 16.0 versus 9.2
\nmonths).<\/p>\n
\u00a0<\/p>\n
In Europe, breast cancer remains the leading cause of cancer death
\namong women, with more than 140,000 deaths in 2024 and more than
\n540,000 patients diagnosed in the same year.2\u00a0Hormone
\nreceptor (HR)-positive breast cancer,\u00a0characterised\u00a0by
\nthe expression of estrogen or progesterone receptors, or both, is
\nthe most common subtype of breast cancer with 70%
\nof\u00a0tumours\u00a0considered HR-positive and
\nHER2-negative.3\u00a0More
\nthan 97% of HR-positive breast cancer\u00a0tumours\u00a0are
\nER-positive.4,5\u00a0Across
\nthe UK, France, Germany, Spain and Italy, approximately 37,000
\npatients with HR-positive metastatic breast cancer\u00a0are treated
\nwith a medicine in the 1st-line setting; most frequently with
\nendocrine therapies paired with CDK4\/6
\ninhibitors.6-8\u00a0However,
\nmany patients have tumours that develop resistance to these
\ntherapies, at which point treatment options are limited and
\nsurvival rates are low, with only approximately 36% of patients
\nanticipated to live beyond five years after
\ndiagnosis.3,8\u00a0Mutations
\nin the\u00a0ESR1\u00a0gene are a key driver of endocrine
\nresistance and are associated with poor outcomes, emerging during
\ntreatment of the disease and becoming more prevalent as the disease
\nprogresses.9,10\u00a0Approximately
\n30% of patients with endocrine sensitive HR-positive disease
\ndevelop\u00a0ESR1\u00a0mutations during 1st-line treatment before
\ndisease progression.6<\/p>\n
\u00a0<\/p>\n
Fran\u00e7ois-Cl\u00e9ment Bidard MD, PhD, Professor of Medical
\nOncology at Institut Curie & Versailles University
\n(Paris\/Saclay) France and co-principal investigator for the trial,
\nsaid: “Today’s approval is welcome news for the one in three
\npatients in Europe with this form of advanced breast cancer whose
\ntumours develop\u00a0ESR1\u00a0mutations before disease progression and are
\nin urgent need of new options that both delay this progression and
\nextend the benefit of 1st-line treatments.\u00a0As the first
\npivotal trial to demonstrate the clinical value of monitoring
\ncirculating tumour DNA in the 1st-line breast cancer setting,
\nSERENA-6 represents a significant advance in clinical practice and
\nit is now important to identify patients who may be able to benefit
\nfrom this combination and intervene promptly before their disease
\nprogresses.”\u00a0\u00a0<\/p>\n
\u00a0<\/p>\n
Dave Fredrickson, Executive Vice President, Oncology Haematology
\nBusiness Unit, AstraZeneca, said: “The approval of
\nthe\u00a0Etcamah\u00a0combination marks an important shift in the
\n1st-line treatment paradigm for patients with ER-positive,
\nHER2-negative advanced breast cancer in Europe, providing a new
\nstandard-of-care to address emerging resistance ahead of disease
\nprogression. It also reflects the strength of AstraZeneca’s
\noncology pipeline and our commitment to translate innovative
\nscience into practice-changing treatment options for
\npatients.”\u00a0\u00a0<\/p>\n
\u00a0<\/p>\n
Data for the key secondary endpoints of time to second disease
\nprogression (PFS2) and overall survival (OS) were immature at the
\ntime of the interim analysis of the SERENA-6 trial, however, a
\nsubsequent pre-planned analysis demonstrated a statistically
\nsignificant and clinically meaningful PFS2 benefit of 25.7 months
\nversus 19.1 months in favour of the\u00a0Etcamah\u00a0combination (HR: 0.63; 95% CI: 0.46-0.86;
\np=0.00373) and OS continued to mature in favour of
\nthe\u00a0Etcamah\u00a0combination (HR: 0.87; 95% CI: 0.57-1.30).
\nThe trial will continue to assess OS as a key secondary
\nendpoint.<\/p>\n
\u00a0<\/p>\n
The safety profile of\u00a0Etcamah\u00a0in combination with palbociclib, ribociclib
\nor abemaciclib in the SERENA-6 trial was consistent with the known
\nsafety profile of each medicine. No new safety concerns were
\nidentified, and discontinuations were very low and similar in both
\narms.1<\/p>\n
\u00a0<\/p>\n
SERENA-6 is the first global, double-blind, registrational Phase
\nIII trial to use a circulating tumour DNA (ctDNA)-guided approach
\nto detect the emergence of endocrine resistance and inform a switch
\nin therapy before disease progression. The innovative trial design
\nused ctDNA monitoring via a blood test at the time of routine
\ntumour scans every two to three months to identify patients for
\nearly signs of endocrine resistance via the emergence
\nof\u00a0ESR1\u00a0mutations. Following detection of
\nan\u00a0ESR1\u00a0mutation without disease progression, the
\nendocrine therapy of patients was switched
\nto\u00a0Etcamah\u00a0from ongoing treatment with an AI, while
\ncontinuing combination with the same CDK4\/6
\ninhibitor.<\/p>\n
\u00a0<\/p>\n
Etcamah\u00a0is also approved
\nin Japan, the United Arab Emirates and Saudi Arabia\u00a0based
\non\u00a0the SERENA-6 Phase III trial.\u00a0Regulatory applications
\nfor\u00a0Etcamah\u00a0in this setting are currently under review
\nin several other countries including the US where
\nthe\u00a0US\u00a0Food and Drug Administration
\nrecently\u00a0extended the
\nPrescription Drug User Fee Act date\u00a0to review the updated results from the
\ntrial.\u00a0<\/p>\n
\u00a0<\/p>\n
Notes<\/p>\n
\u00a0<\/p>\n
HR-positive breast cancer\u00a0\u00a0<\/p>\n
Breast cancer is the second most common cancer and one of the
\nleading causes of cancer-related deaths
\nworldwide.11\u00a0More
\nthan two million patients were diagnosed with breast cancer in
\n2024, with more than 690,000 deaths globally.11\u00a0While
\nsurvival rates are high for those diagnosed with early breast
\ncancer, only about 30% of patients diagnosed with or who progress
\nto metastatic disease are expected to live five years following
\ndiagnosis.3<\/p>\n
\n\u00a0<\/p>\n
Globally, approximately 200,000 patients with HR-positive breast
\ncancer are treated with a medicine in the 1st-line setting; most
\nfrequently with endocrine therapies that target ER-driven disease,
\nwhich are often paired with CDK4\/6 inhibitors.6-8<\/p>\n
\n\u00a0<\/p>\n
The\u202foptimisation\u202fof endocrine therapy and overcoming
\nresistance to enable patients to
\ncontinue\u202fbenefiting\u202ffrom these treatments, as well
\nas\u202fidentifying\u202fnew therapies for those who are less
\nlikely to benefit, are active areas of focus for breast cancer
\nresearch.\u202f\u00a0<\/p>\n
\n\u00a0<\/p>\n
SERENA-6\u00a0<\/p>\n
SERENA-6 is a Phase III, double-blind,\u00a0randomised\u00a0trial
\nevaluating the efficacy and safety of\u00a0Etcamah\u00a0in combination with a CDK4\/6 inhibitor
\n(palbociclib,\u00a0ribociclib\u00a0or\u00a0abemaciclib) versus
\ntreatment with an AI (anastrozole or letrozole) in combination with
\na CDK4\/6 inhibitor
\n(palbociclib,\u00a0ribociclib\u00a0or\u00a0abemaciclib) in patients
\nwith HR-positive, HER2-negative advanced breast cancer (patients
\nwith either locally advanced disease, or metastatic disease)
\nwhose\u00a0tumours\u00a0have an emergent\u00a0ESR1\u00a0mutation.\u00a0<\/p>\n
\n\u00a0<\/p>\n
The global trial enrolled 315 adult patients with histologically
\nconfirmed HR-positive, HER2-negative advanced breast cancer,
\nundergoing treatment with an AI in combination with a CDK4\/6
\ninhibitor as 1st-line treatment. The primary endpoint of the
\nSERENA-6 trial is PFS as\u00a0assessed by\u00a0investigator, with
\nsecondary endpoints including OS, and PFS2 by investigator
\nassessment.\u00a0<\/p>\n
\n\u00a0<\/p>\n
Etcamah<\/p>\n
Etcamah\u00a0(camizestrant) is
\na potent, next-generation oral selective estrogen receptor degrader
\n(SERD) and complete ER antagonist, administered orally, once
\ndaily.\u00a0The recommended dose of\u00a0Etcamah\u00a0in combination with a CDK4\/6 inhibitor is
\n75mg.<\/p>\n
\u00a0<\/p>\n
Etcamah\u00a0in combination
\nwith a CDK4\/6 inhibitor (palbociclib, ribociclib or
\nabemaciclib)\u00a0is approved in the EU, Japan and several other
\ncountries for the treatment of adult patients with HR-positive (or
\nER-positive), HER2-negative locally advanced or metastatic breast
\ncancer upon detection or emergence of\u00a0ESR1\u00a0mutation and without disease progression
\nduring 1st-line endocrine therapy based on the results from the
\nSERENA-6 trial.<\/p>\n
\u00a0<\/p>\n
The broad, robust and innovative\u00a0Etcamah\u00a0clinical development programme, including
\nthe SERENA-4, CAMBRIA-1 and CAMBRIA-2 Phase III trials, is
\nevaluating the safety and efficacy of\u00a0Etcamah\u00a0when used as a monotherapy or in combination
\nwith CDK4\/6 inhibitors to address a number of areas of unmet need
\nin HR-positive, HER2-negative breast
\ncancer.\u00a0<\/p>\n
\u00a0<\/p>\n
Etcamah\u00a0has demonstrated
\nanti-cancer activity across a range of preclinical models,
\nincluding those with ER-activating mutations. In the SERENA-2 Phase
\nII trial, camizestrant demonstrated a statistically significant and
\nclinically meaningful improvement in PFS
\nversus\u00a0Faslodex\u00a0(fulvestrant) in the overall trial
\npopulation, including in patients with\u00a0ESR1\u00a0tumour mutations irrespective of prior
\ntreatment with CDK4\/6 inhibitors in patients with ER-positive
\nlocally advanced or metastatic breast cancer, previously treated
\nwith endocrine therapy. The SERENA-1 Phase I trial demonstrated
\nthat camizestrant is well tolerated and has a promising anti-tumour
\nprofile when administered alone or in combination with palbociclib,
\nribociclib and abemaciclib; three widely used CDK4\/6
\ninhibitors.<\/p>\n
\u00a0<\/p>\n
AstraZeneca in breast cancer\u202f\u00a0<\/p>\n
Driven by a growing understanding of breast cancer biology,
\nAstraZeneca is challenging, and redefining, the current clinical
\nparadigm for how breast cancer is classified and treated to deliver
\neven more effective treatments to patients in need – with the bold
\nambition to one day eliminate breast cancer as a cause of
\ndeath.<\/p>\n
\u00a0<\/p>\n
AstraZeneca has a comprehensive portfolio of approved and promising
\ncompounds in development that\u00a0leverage\u00a0different
\nmechanisms of action to address the biologically diverse breast
\ncancer tumour environment.\u00a0<\/p>\n
\u00a0<\/p>\n
With\u202fEnhertu\u202f(trastuzumab
\nderuxtecan), a HER2-directed antibody drug conjugate (ADC),
\nAstraZeneca and Daiichi Sankyo are aiming to improve outcomes in
\npreviously treated HER2-positive, HER2-low and HER2-ultralow
\nmetastatic breast cancer and are exploring its potential in earlier
\nlines of treatment and in new breast cancer
\nsettings.\u00a0<\/p>\n
\u00a0<\/p>\n
In HR-positive breast cancer, AstraZeneca continues to improve
\noutcomes with foundational medicines\u00a0Faslodex\u00a0and\u00a0Zoladex\u00a0(goserelin) and aims to reshape the
\nHR-positive space with first-in-class AKT
\ninhibitor,\u00a0Truqap\u00a0(capivasertib), the TROP-2-directed
\nADC,\u00a0Datroway\u00a0(datopotamab deruxtecan) and next-generation
\noral SERD,\u00a0Etcamah.<\/p>\n
\u00a0<\/p>\n
PARP inhibitor\u202fLynparza\u202f(olaparib)
\nis a targeted treatment\u00a0option\u00a0that has been studied in
\nearly and metastatic breast cancer patients with an
\ninherited\u00a0BRCA\u00a0mutation. AstraZeneca with MSD (Merck & Co.,
\nInc. in the US and Canada) continue to
\nresearch\u202fLynparza\u202fin
\nthese\u00a0settings. AstraZeneca is also exploring the potential
\nof\u00a0saruparib, a potent and selective inhibitor of PARP1, in
\ncombination with\u00a0Etcamah\u00a0in\u00a0BRCA-mutated, HR-positive, HER2-negative advanced
\nbreast cancer.\u00a0<\/p>\n
\u00a0<\/p>\n
To bring much-needed treatment options to patients with
\ntriple-negative breast cancer, an aggressive form of breast cancer,
\nAstraZeneca is collaborating with Daiichi Sankyo to evaluate the
\npotential of\u00a0Datroway\u00a0alone and in combination with
\nimmunotherapy\u00a0Imfinzi\u00a0(durvalumab).<\/p>\n
\u00a0<\/p>\n
AstraZeneca in oncology\u202f\u00a0<\/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
\npatients.\u202f\u00a0<\/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\u00a0catalyse\u00a0changes in the practice of medicine
\nand transform the patient experience.\u202f\u00a0<\/p>\n
\u00a0<\/p>\n
AstraZeneca has the vision to redefine cancer care and, one
\nday,\u202feliminate\u202fcancer as a cause of
\ndeath.\u00a0<\/p>\n
\u00a0<\/p>\n
AstraZeneca\u00a0<\/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\u00a0\u00a0<\/p>\n
For details on how to contact the Investor Relations Team, please
\nclick\u00a0here.
\nFor Media contacts, click\u00a0here.\u00a0<\/p>\n
\u00a0<\/p>\n
References<\/p>\n
\n1.\u00a0\u00a0\u00a0Bidard FC, et al. First-Line
\nCamizestrant for Emerging ESR1-Mutated Advanced Breast
\nCancer.\u00a0N Engl J
\nMed.\u00a02025; DOI:
\n10.1056\/NEJMoa2502929.<\/p>\n
\n2.\u00a0\u00a0\u00a0World Health Organization. GLOBOCAN Europe Fact
\nSheet. Available at:\u00a0https:\/\/gco.iarc.who.int\/media\/globocan\/factsheets\/populations\/908-europe-fact-sheet.pdf.
\nAccessed July 2026.<\/p>\n
\n3.\u00a0\u00a0\u00a0National Cancer Institute.
\nCancer Stat facts: Female breast cancer subtypes. Available
\nat:\u00a0https:\/\/seer.cancer.gov\/statfacts\/html\/breast-subtypes.html.\u00a0Accessed
\nJuly 2026.<\/p>\n
\n4.\u00a0\u00a0 Bae S, et al. Poor prognosis of
\nsingle hormone receptor positive breast cancer: similar outcome as
\ntriple-negative breast cancer.\u00a0BMC Cancer. 2015; 15:138.<\/p>\n
\n5.\u00a0\u00a0\u00a0Cserni G, et al. Estrogen
\nReceptor Negative and Progesterone Receptor Positive Breast
\nCarcinomas-How Frequent are they?\u00a0Pathol. Oncol.
\nRes. 2011;
\n17:663-668.<\/p>\n
\n6.\u00a0\u00a0
\nCerner CancerMPact database. Accessed July 2026.<\/p>\n
\n7.\u00a0\u00a0 Lin M, et al. Comparative Overall
\nSurvival of CDK4\/6 Inhibitors Plus Endocrine Therapy vs. Endocrine
\nTherapy Alone for Hormone receptor-positive, HER2-negative
\nmetastatic breast cancer.\u00a0J Cancer. 2020; 10.7150\/jca.48944.<\/p>\n
\n8.\u00a0\u00a0 Lloyd M R, et al. Mechanisms of
\nResistance to CDK4\/6 Blockade in Advanced Hormone
\nReceptor-positive, HER2-negative Breast Cancer and Emerging
\nTherapeutic Opportunities.\u00a0Clin Cancer
\nRes. 2022;
\n28(5):821-30.<\/p>\n
\n9.\u00a0\u00a0 Brett O, et al. ESR1 mutation as an
\nemerging clinical biomarker in metastatic hormone receptor-positive
\nbreast cancer.\u00a0Breast Cancer
\nRes. 2021;
\n23:85.<\/p>\n
\n10.\u00a0 Zundelevich A, et al. ESR1 mutations are
\nfrequent in newly diagnosed metastatic and loco-regional recurrence
\nof endocrine-treated breast cancer and carry worse
\nprognosis.\u00a0Breast Cancer
\nRes. 2020;
\n22:16.<\/p>\n
\n11.\u00a0 Sung H, et al. Global cancer statistics
\n2024: GLOBOCAN estimates of incidence and mortality worldwide for
\n34 cancers in 186 countries.\u00a0CA\u00a0Cancer J
\nClin. 2026; DOI:
\n10.3322\/caac.70090.<\/p>\n
\n\u00a0<\/p>\n
Matthew Bowden<\/p>\n
Company Secretary<\/p>\n
AstraZeneca PLC<\/p>\n
\n\u00a0<\/p>\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
\nDate:
\n23 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:
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