Akt-1 inhibitors(Serine/threonine-protein kinase AKT inhibitors), Akt-2 inhibitors(Serine/threonine-protein kinase AKT2 inhibitors), Akt-3 inhibitors(Serine/threonine-protein kinase AKT3 inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesDigestive System Disorders+ [9]

Active Indication

ER-positive/HER2-negative Breast CancerBreast CancerHormone receptor positive HER2 negative breast cancer+ [22]

Inactive Indication

Advanced cancerAdvanced Gastric AdenocarcinomaAdvanced gastric carcinoma+ [4]

Originator Organization

AstraZeneca PLC

Active Organization

AstraZeneca PLCAstraZeneca AB

AstraZeneca Investment (China) Co. Ltd.

+ [9]

Inactive Organization

Samsung Medical Center

Yale University

Drug Highest PhaseApproved

First Approval Date

US (16 Nov 2023),

Hormone receptor positive HER2 negative breast cancer

RegulationPriority Review (US)

Structure/Sequence

Molecular FormulaC21H25ClN6O2

InChIKeyJDUBGYFRJFOXQC-KRWDZBQOSA-N

CAS Registry1143532-39-1

Clinical Trials associated with Capivasertib

ISRCTN99425493

/ RecruitingPhase 2IIT

Randomised Phase II open-label window of opportunity trial AKTivate - Identifying target engagement and biomarkers of response, including an imaging biomarker, in participants receiving Capivasertib plus Exemestane and Capivasertib alone in post-menopausal participants with oestrogen receptor positive (ER+) early-stage breast cancer

Start Date01 Oct 2025

Sponsor / Collaborator

Cambridge University Hospitals NHS Foundation Trust

NCT06613516

/ Not yet recruitingPhase 2IIT

CaptAin - Effect of Capivasertib on ctDNA in ER Positive Breast Cancer

There is growing evidence that cancer DNA (called circulating tumour DNA - ctDNA) in the blood is often an early sign that the cancer is likely to return. The aim of this study is to investigate whether treating women who have detectable ctDNA in their blood with a drug called Capivasertib can help control ctDNA levels and prevent developing metastatic or secondary breast cancer.
A recruitment of 20 women with oestrogen receptor (ER) positive breast cancer (who are already on standard of care hormone therapy who are being treated with curative intent) is aimed for; which means that the disease has not yet spread to distant parts of the body. Each subject will be dosed with 400mg of Capivasertib twice a day for a maximum period of two years.

Start Date01 Feb 2025

Sponsor / Collaborator

Imperial College London

[+3]

NCT06764186

/ RecruitingPhase 3

A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With HR+ / HER2- Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain

The purpose of this study is to evaluate the effectiveness and safety of capivasertib + fulvestrant treatment administration in patients with locally advanced (inoperable) or metastatic HR+ / HER2- breast cancer with PIK3CA/AKT1/PTEN-altered following recurrence or progression on or after endocrine therapy and CDK4/6 inhibitor.

Start Date07 Jan 2025

Sponsor / Collaborator

AstraZeneca PLC

[+2]

100 Clinical Results associated with Capivasertib

100 Translational Medicine associated with Capivasertib

100 Patents (Medical) associated with Capivasertib

404

Literatures (Medical) associated with Capivasertib

01 Apr 2025·Anti-Cancer Agents in Medicinal Chemistry

Capivasertib: First Approved AKT inhibitor for the Treatment of Patients with Breast Cancer

Article

Author: De, Surya K.

Breast cancer frequently occurs in women. Among the several types of breast cancers, almost 50% of breast cancers are caused by one or more gene mutations of the PI3K/mTOR/AKT pathway. Capivasertib, the first AKT inhibitor, was authorized by the US FDA on November 16, 2023. It is used for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2 negative metastatic breast cancer with at least one alteration on PIK3CA/AKT1/PTEN. In this short perspective, Capivasertib’s physicochemical properties, synthesis, mechanism of action, binding mode, pharmacokinetics, drug interaction studies, and treatment-emergent adverse events are discussed.

01 Mar 2025·PHARMACOECONOMICS

Cost-Effectiveness of Capivasertib as a Second-Line Therapy for Advanced Breast Cancer

Article

Author: Mital, Shweta ; Nguyen, Trang T H

BACKGROUND:

Capivasertib, a first-in-class AKT inhibitor, was recently approved as a second-line treatment for advanced breast cancer. However, capivasertib is expensive, raising questions over its economic value. This study provides the first evidence on the cost effectiveness of adding capivasertib to endocrine therapy (fulvestrant) for patients with PIK3CA/AKT1/PTEN-altered, hormone receptor-positive (HR⁺) human epidermal growth factor receptor 2-negative (HER2^-) advanced breast cancer.

METHODS:

A Markov model was built to compare the costs and effectiveness of three treatment strategies. The first strategy involved adding capivasertib to fulvestrant for all patients, while the second strategy involved adding it for only postmenopausal women. The third strategy involved treatment with fulvestrant alone. Analyses were conducted from a US payer perspective over a lifetime horizon. Costs were measured in 2023 US dollars, and effectiveness was measured in life years (LYs) and quality adjusted life years (QALYs), discounted at 3% per year. One-way sensitivity analyses, probabilistic sensitivity analyses, and scenario analyses were conducted to assess the robustness of results.

RESULTS:

The addition of capivasertib to fulvestrant for all patients was associated with $410,765 higher costs and 1.46 additional quality adjusted life years (QALYs) compared with fulvestrant alone, resulting in an incremental cost effectiveness ratio of $280,854/QALY. The strategy of adding capivasertib for only patients who are postmenopausal was extended dominated, i.e., yielded fewer QALYs at a higher cost per QALY than if capivasertib was added for all patients. These results were found to be robust in sensitivity and scenario analyses.

CONCLUSIONS:

At its current price, our analysis suggests that the addition of capivasertib to fulvestrant as a second line treatment is not cost effective versus fulvestrant alone at a willingness-to-pay threshold of $100,000/QALY. The price of capivasertib will need to be reduced by nearly 70% (to $7000 per cycle) for it to become cost effective.

01 Mar 2025·MATERIALS LETTERS

hHAP-MSN@AC nanoparticles targeting PI3K-AKT pathway for the treatment of breast cancer

Author: Yao, Xiaoru ; Zhang, Pingping ; Yang, Wenjia ; Xu, Minghui ; Shao, Xinzhe

Hyaluronic acid-grafted hydroxyapatite-hybridized mesoporous silica nanoparticles co-loaded Alpelisib and Capivasertib (hHAP-MSN@AC) were constructed for targeted synergistic treatment of breast cancer.In vitro drug release experiments showed that the cumulative release rates of Alpelisib and Capivasertib in tumor microacidic conditions (pH 6.5) and tumor cell environment (pH = 5.5) were higher than that in normal tissue environment (pH = 7.4), which suggested that hHAP-MSN@AC had acid-responsive drug release capacity.In vitro cellular uptake assay indicated more hHAP-MSN@Cy5.5 were uptaken by breast cancer cells BT474 under tumor microacidic conditions, and the uptake of hHAP-MSN@Cy5.5 was time-dependented.The western blot assay showed that hHAP-MSN@AC could simultaneously down-regulate the expression of PI3K p110α and p-AKT proteins, thus synergistically inhibited the PI3K-AKT signalling pathway. hHAP-MSN@AC constructed in this paper had promising applications in the synergistic targeted treatment of breast cancer.

116

News (Medical) associated with Capivasertib

26 Feb 2025

·pipelinereview.com

Camizestrant demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival in 1st-line advanced HR-positive breast cancer with an emergent ESR1 tumour mutation in SERENA-6 Phase III trial

First and only next-generation oral SERD and complete ER antagonist to demonstrate 1st-line benefit in combination with widely approved CDK4/6 inhibitors LONDON, UK I February 26, 2025 I Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation. The key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of this interim analysis. However, the camizestrant combination demonstrated a trend toward improvement in PFS2. The trial will continue as planned to further assess key secondary endpoints. SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The novel trial design used ctDNA monitoring at the time of routine tumour scan visits to identify patients for early signs of endocrine resistance and the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor. François-Clément Bidard, MD, PhD, Professor of Medical Oncology at Institut Curie & UVSQ/Université Paris-Saclay, France, and co-principal investigator for the trial, said: “Patients have an urgent need for new treatments that delay disease progression on 1st-line endocrine-based therapies. The results from SERENA-6 show that switching from an aromatase inhibitor to camizestrant in combination with any of the three CDK4/6 inhibitors after emergence of an ESR1 mutation delays progression of disease and extends the benefit of 1st-line treatment, representing an important step forward for patients, and a potential shift in clinical practice.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “These impressive results demonstrate the versatility of camizestrant in combination with all the widely approved CDK4/6 inhibitors to provide a well-tolerated new potential treatment option in the first-line setting for the one in three patients with HR-positive, HER2-negative advanced breast cancer whose tumours develop ESR1 mutations during treatment with an aromatase inhibitor in combination with a CDK4/6 inhibitor. This critical read-out moves us one step closer to realising the potential of camizestrant to become a new standard-of-care as we look to shift the treatment paradigm and establish this new endocrine therapy backbone in HR-positive breast cancer.” The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in SERENA-6 was consistent with the known safety profile of each medicine. No new safety concerns were identified and discontinuations were very low and similar in both arms. Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target estrogen receptor (ER)-driven disease, which are often paired with CDK4/6 inhibitors. 1-3 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. 3 Mutations in the ESR1 gene are a key driver of endocrine resistance and are widely tested for in clinical practice. 4,5 Thesemutations develop during treatment of the disease, becoming more prevalent as the disease progresses and are associated with poor outcomes. 4,5 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment without disease progression. 1 Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Notes HR-positive breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 6 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally. 6 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis. 7 HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative. 7 ERs often drive the growth of HR-positive breast cancer cells. 8 Once resistance to the treatment of HR-positive breast cancer with CDK4/6 inhibitors and current endocrine therapies occurs, treatment options are limited and survival rates are low with 35% of patients anticipated to live beyond five years after diagnosis. 3,7,9 The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research. SERENA-6 SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib ) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation. The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment. Camizestrant Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer. AstraZeneca’s broad, robust and innovative clinical development programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with other agents to address a number of areas of unmet need in this specific type of breast cancer. Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated PFS benefit versus Faslodex (fulvestrant) irrespective of ESR1 mutation status or prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors. Combinations with other agents are ongoing in SERENA-1. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, 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. With Enhertu (trastuzumab deruxtecan), a HER2-directed ADC, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD and potential new medicine camizestrant. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in 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 these settings and to explore its potential in earlier disease. AstraZeneca is also exploring the efficacy and safety of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). 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’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @ AstraZeneca . Contacts For details on how to contact the Investor Relations Team, please click here . For Media contacts, click here . References SOURCE: AstraZeneca

Clinical ResultPhase 3Phase 2Phase 1

08 Feb 2025

·www.echemi.com

Pharmaceutical Giants Shuffle as Pfizer Reclaims Top Spot with AstraZeneca Surging by 21%

The global pharmaceutical landscape has dramatically shifted as 2025 approaches, marking a significant reshuffle among the top players. Pfizer has regained its position as the leader in pharmaceutical revenue, with a notable resurgence in its oncology division, showing potential to challenge the top cancer drug revenue spots. This news, while not entirely surprising given earlier trends, sets the stage for fierce competition. In a remarkable twist, AstraZeneca (AZ) has achieved a staggering 21% growth, surpassing both Roche and Novartis to become the year’s biggest "dark horse." AZ’s ascent into the top five revenue ranks showcases its impressive performance, particularly driven by its innovative oncology and cardiovascular products. Meanwhile, AbbVie has astounded the industry with a 66.66% increase in research and development (R&D) spending, reaching $12.79 billion. This move propelled AbbVie into the top five for R&D spending relative to total revenue, despite its previous low rankings. The substantial investment aligns with the company’s strategy to reinforce its pipeline post-Humira patent expiration. However, not all news is positive. Both Roche and Novartis are facing setbacks, struggling to yield significant returns on their R&D investments. GlaxoSmithKline (GSK) is also on the verge of being pushed out of the top ten, highlighting the shifting dynamics in the pharmaceutical sector. Pfizer’s resurgence is particularly noteworthy. After a year of restructuring, which included cost-cutting and layoffs, the company is back at the forefront, with its oncology business generating over $15 billion in revenue. Pfizer's strategic acquisition of Seagen has provided it with a new revenue stream, positioning it well within the oncology market. AstraZeneca's growth can be attributed to its robust performance in oncology, cardiovascular, and respiratory sectors, with several new products showing over 50% growth. These include Enhertu, Truqap, and Tezspire, all contributing significantly to its revenue boost. AZ’s goal of achieving $80 billion in total revenue by 2030 now feels more attainable. In contrast, Roche's core oncology business, which constitutes 51.4% of its revenue, only grew by 7%. Although its blood cancer treatments have performed well, the overall sluggish growth reflects broader challenges within the company. Similarly, Novartis is grappling with stagnation, unable to keep pace with the rapid advancements seen by competitors. The vaccine market is also showing signs of fatigue, with major players like Pfizer, AstraZeneca, and Merck experiencing declines in vaccine sales. For instance, Pfizer’s pneumonia vaccine sales fell 1%, while AstraZeneca’s vaccine business faced significant drops, except for its RSV treatment, which achieved over 200% growth. In the realm of R&D, Merck remains a powerhouse, despite a 40% drop in R&D spending. The company allocated $17.94 billion to R&D, maintaining its position among the top spenders. Merck's focus remains on expanding the reach of its blockbuster cancer drug, Keytruda, which continues to generate substantial revenue. As the pharmaceutical industry evolves, it’s clear that collaboration and strategic investments will be crucial for survival. Companies must adapt to the changing landscape, leveraging innovative approaches to stay competitive and maintain their market positions.

AcquisitionVaccine

06 Feb 2025

·www.businesswire.com

AstraZeneca’s Full Year and Q4 2024 results

CAMBRIDGE, England--( BUSINESS WIRE )--AstraZeneca: Revenue and EPS summary FY 2024 % Change Q4 2024 % Change $m Actual CER i $m Actual CER - Product Sales 50,938 16 19 13,362 18 19 - Alliance Revenue 2,212 55 55 714 68 69 - Collaboration Revenue 923 56 54 815 >2x >2x Total Revenue 54,073 18 21 14,891 24 25 Reported EPS $4.54 18 29 $0.97 56 71 Core ii EPS $8.21 13 19 $2.09 44 49 Financial performance for FY 2024 (Growth numbers at constant exchange rates) Total Revenue up 21% to $54,073m, driven by a 19% increase in Product Sales, continued growth of partnered medicines (Alliance Revenue) and the achievement of sales-based milestones (Collaboration Revenue) Total Revenue growth from Oncology was 24%, CVRM 20%, R&I 25%, V&I 8% and Rare Disease 16% Core EPS increased 19% to $8.21 Second interim dividend declared of $2.10 per share, making a total annual dividend declared for FY 2024 of $3.10 per share, an increase of 7%. Dividend to be further increased in FY 2025 Guidance for FY 2025: Total Revenue is expected to increase by a high single-digit percentage and Core EPS is expected to increase by a low double-digit percentage, both at CER Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “ Our company delivered a very strong performance in 2024 with Total Revenue and Core EPS up 21% and 19% respectively. We also delivered nine positive high value Phase III studies in the year, which coupled with increasing demand for our medicines in all key regions, will help sustain our growth momentum into 2025. This year marks the beginning of an unprecedented, catalyst-rich period for our company, an important step on our Ambition 2030 journey to deliver $80 billion Total Revenue by the end of the decade. In 2025 alone, we anticipate the first Phase III data for seven new medicines, along with several important new indication opportunities for our existing medicines. We are also investing in and making significant progress with transformative technologies that have the potential to drive our growth well beyond 2030, many of which have now entered pivotal trials.” Key milestones achieved since the prior results announcement Positive read-outs for Truqap in combination with abiraterone and androgen deprivation therapy in PTEN -deficient de novo metastatic hormone-sensitive prostate cancer (CAPItello-281) and Tagrisso with or without chemotherapy in resectable early-stage EGFR m NSCLC (NeoADAURA) US approvals for Imfinzi in limited-stage small cell lung cancer (ADRIATIC), Calquence in combination with bendamustine and rituximab in mantle cell lymphoma (ECHO), Datroway (datopotamab deruxtecan) in HR+ HER2- metastatic breast cancer (TROPION-Breast01) and Enhertu in chemotherapy-naïve HER2-low and -ultralow metastatic breast cancer (DESTINY-Breast06). EU approvals for Tagrisso in unresectable EGFR m NSCLC (LAURA) and Kavigale for prevention of COVID-19 (SUPERNOVA). Japan approvals for Imfinzi in endometrial cancer (DUO-E), Lynparza plus Imfinzi in pMMR endometrial cancer (DUO-E), Calquence tablet formulation in chronic / small lymphocytic leukaemia, Datroway in HR+ HER2- metastatic breast cancer, Fasenra in EGPA (MANDARA) and Kavigale for prevention of COVID-19. China approvals for Lynparza in gBRCAm HER2- early breast cancer (OlympiA), Orpathys in locally advanced or metastatic MET Exon 14 NSCLC (NCT04923945) Guidance The Company issues its Total Revenue and Core EPS guidance for FY 2025 at CER, based on the average foreign exchange rates through 2024. Total Revenue is expected to increase by a high single-digit percentage Core EPS is expected to increase by a low double-digit percentage The Core Tax rate is expected to be between 18-22% The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement. Currency impact If foreign exchange rates for February 2025 to December 2025 were to remain at the average rates seen in January 2025, it is anticipated that Total Revenue in FY 2025 would incur a low single-digit percentage adverse impact compared to the performance at CER, and Core EPS would incur a mid-single-digit percentage adverse impact. The Company’s foreign exchange rate sensitivity analysis is provided in Table 17. Capital allocation In FY 2025, the Company intends to increase the annual dividend declared to $3.20 per share. The Company also expects to increase capital expenditure iii by approximately 50%, driven by manufacturing expansion projects and investment in IT systems, to support portfolio growth and build capacity for transformative technologies. China In relation to the illegal drug importation allegations, in January 2025, AstraZeneca received a Notice of Transfer to the Prosecutor and an Appraisal Opinion from the Shenzhen City Customs Office regarding suspected unpaid importation taxes amounting to $0.9 million. To the best of AstraZeneca’s knowledge, the importation taxes referred to in the Appraisal Opinion relate to Imfinzi and Imjudo . A fine of between one and five times the amount of unpaid importation taxes may also be levied if AstraZeneca is found liable. AstraZeneca continues to fully cooperate with the Chinese authorities. In December 2024 AstraZeneca announced the appointment of Iskra Reic as Executive Vice President, International, which encompasses China, Asian and Eurasian markets, Middle East & Africa, Latin America, Australia & New Zealand. Iskra succeeds Leon Wang who is on extended leave from the Company while under investigation in China. Table 1: Key elements of Total Revenue performance in Q4 2024 % Change Revenue type $m Actual % CER % Product Sales 13,362 18 19 Alliance Revenue 714 68 69 $392m Enhertu (Q4 2023: $281m) $133m Tezspire (Q4 2023: $80m) $161m Beyfortus (Q4 2023: $41m) Collaboration Revenue 815 >2x >2x $600m Lynparza (Q4 2023: $245m) $111m Beyfortus (Q4 2023: $27m) $100m Koselugo (Q4 2023: nil) Total Revenue 14,891 24 25 Therapy areas $m Actual % CER % Oncology 6,344 27 29 Tagrisso up 20% (21% at CER), Calquence up 20%, Enhertu up 48% (54% at CER) CVRM 3,138 16 17 Farxiga up 21% (22% at CER) , Lokelma up 35% R&I 2,127 27 28 Breztri up 29%. Saphnelo up 65%, Tezspire up 86% (85% at CER), Symbicort up 31% (33% CER) V&I 651 58 55 Beyfortus Total Revenue up >3x Rare Disease 2,377 21 22 Ultomiris up 32% (33% at CER), partially offset by decline in Soliris of 24% (22% at CER), Strensiq up 38% (37% at CER) and Koselugo up >3x Other Medicines 254 (7) (6) Total Revenue 14,891 24 25 Regions $m Actual % CER % US 6,532 28 28 Product Sales up 25% Emerging Markets 3,134 13 19 - China 1,364 (1) (3) Decline primarily due to low rates of seasonal respiratory viral infections, and impact from year-end hospital budget dynamics - Ex-China Emerging Markets 1,770 26 42 Europe 3,948 37 35 Product Sales up 20% (18% at CER) Established RoW 1,277 1 2 Total Revenue 14,891 24 25 Key alliance medicines Combined sales of Enhertu , recorded by Daiichi Sankyo Company Limited (Daiichi Sankyo) and AstraZeneca, amounted to $3,754m in FY 2024 (FY 2023: $2,566m) Combined sales of Tezspire , recorded by Amgen and AstraZeneca, amounted to $1,219m in FY 2024 (FY 2023: $653m) Table 2: Key elements of financial performance in Q4 2024 Metric Reported Reported change Core Core change Comments iv Total Revenue $14,891m 24% Actual 25% CER $14,891m 24% Actual 25% CER See Table 1 and the Total Revenue section of this document for further details Product Sales Gross Margin 80% Stable Actual +1pp CER 79% -1pp Actual Stable CER Variations in Product Sales Gross Margin can be expected between periods, due to product seasonality, foreign exchange fluctuations and other effects R&D expense $4,677m 52% Actual 52% CER $3,573m 23% Actual 22% CER Increased investment in the pipeline Core R&D-to-Total Revenue ratio of 24% (Q4 2023: 24%) Reported R&D includes $753m impairment recorded against the vemircopan (ALXN2050) intangible asset SG&A expense $5,410m 1% Actual 1% CER $4,275m 6% Actual 7% CER Market development for recent launches and pre-launch activities Core SG&A-to-Total Revenue ratio of 29% (Q4 2023: 34%) Other operating income and expense v $100m -7% Actual -6% CER $101m -7% Actual -6% CER Operating Margin 14% +3pp Actual +4pp CER 28% +5pp Actual +6pp CER See commentary above on Gross Margin, R&D, SG&A and Other operating income and expense Net finance expense $365m 9% Actual 8% CER $310m 20% Actual 20% CER Recent debt issued at higher interest rates Decrease in interest income Higher level of Net debt Tax rate 10% +17pp Actual +15pp CER 16% +7pp Actual +7pp CER Variations in the tax rate can be expected between periods EPS $0.97 56% Actual 71% CER $2.09 44% Actual 49% CER Further details of differences between Reported and Core are shown in Table 12 Table 3: Pipeline highlights since prior results announcement Event Medicine Indication / Trial Event Regulatory approvals and other regulatory actions Tagrisso EGFR m NSCLC (Stage III unresectable) (LAURA) Regulatory approval (EU, CN) Imfinzi Limited-stage SCLC (ADRIATIC) Regulatory approval (EU) Imfinzi Advanced endometrial cancer Regulatory approval (JP) Calquence Tablets for chronic lymphocytic leukaemia Regulatory approval (JP) Calquence Mantle cell lymphoma (1st-line) (ECHO) Regulatory approval (US) Lynparza + Imfinzi Advanced endometrial cancer with mismatch repair proficiency (DUO-E) Regulatory approval (JP) Lynparza gBRCAm HER2- eBC (OlympiA) Regulatory approval (CN) Enhertu HR+ HER2-low and -ultralow mBC (DESTINY-Breast06) Regulatory approval (US) Datroway HR+ HER2- mBC (TROPION-Breast01) Regulatory approval (JP, US) Orpathys MET exon 14 skipping altered NSCLC (NCT04923945) Regulatory approval (CN) Fasenra EGPA (MANDARA) Regulatory approval (JP) Kavigale Prevention of COVID-19 (SUPERNOVA) Regulatory approval (EU, JP) Regulatory submissions or acceptances* Imfinzi Muscle-invasive bladder cancer (NIAGARA) Regulatory submission (US, JP) Imfinzi + Imjudo NSCLC (1st-line) (POSEIDON) Regulatory submission (CN) Calquence Chronic lymphocytic leukaemia (1st-line) (AMPLIFY) Regulatory submission (EU) Datroway EGFR m NSCLC (later line) (TROPION-Lung05) Regulatory submission (US) Tezspire Severe uncontrolled asthma (NAVIGATOR/ DIRECTION) Regulatory submission (CN) Koselugo Neurofibromatosis type 1 adult (KOMET) Regulatory submission (EU, JP) Phase III / registrational data readouts and other developments Tagrisso Resectable early-stage EGFR m NSCLC (NeoADAURA) Primary endpoint met Truqap PTEN -deficient de novo metastatic hormone-sensitive prostate cancer (CAPItello-281) Primary endpoint met *US, EU and China regulatory submission denotes filing acceptance Other pipeline updates In January 2025, the vemircopan (ALXN2050) Phase II development programme was terminated. The decision was based on safety and efficacy data from Phase II trials. Upcoming pipeline catalysts For recent trial starts and anticipated timings of key trial readouts, please refer to the Clinical Trials Appendix, available on www.astrazeneca.com/investor-relations.html . Sustainability highlights The Company convened an event on health equity for investors and analysts in November that detailed AstraZeneca’s health equity strategy, which is embedded from the Company’s science through to healthcare delivery and community engagement. At the end of 2024, the Company’s cumulative reduction in Scope 1 and 2 greenhouse gas (GHG) emissions was 77.5% from the 2015 baseline. Conference call A conference call and webcast for investors and analysts will begin today, 6 February 2025, at 11:00 UK time. Details can be accessed via astrazeneca.com . Reporting calendar The Company intends to publish its Q1 2025 results on 29 April 2025. To read AstraZeneca's Full Year and Q4 2024 Financial Results press release in full, click here .

Phase 2Financial StatementExecutive ChangeDrug ApprovalPhase 3

100 Deals associated with Capivasertib

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Approved

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Indication	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	EU	AstraZeneca AB	17 Jun 2024
ER-positive/HER2-negative Breast Cancer	IS	AstraZeneca AB	17 Jun 2024
ER-positive/HER2-negative Breast Cancer	LI	AstraZeneca AB	17 Jun 2024
ER-positive/HER2-negative Breast Cancer	NO	AstraZeneca AB	17 Jun 2024
Breast Cancer	CA	AstraZeneca Canada, Inc.	26 Jan 2024
Hormone receptor positive HER2 negative breast cancer	US	AstraZeneca Pharmaceuticals LP	16 Nov 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally advanced breast cancer	Phase 3	ES	AstraZeneca PLC	07 Jan 2025
Metastatic breast cancer	Phase 3	ES	AstraZeneca PLC	07 Jan 2025
Advanced breast cancer	Phase 3	CN	AstraZeneca AB	26 Sep 2024
Metastatic castration-resistant prostate cancer	Phase 3	US	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	CN	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	JP	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	AU	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	BE	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	BR	AstraZeneca PLC	25 Mar 2022
Metastatic castration-resistant prostate cancer	Phase 3	CA	AstraZeneca PLC	25 Mar 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04305496 (CAPItello-291, Pubmed \| J Clin Oncol)	Phase 3	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer PIK3CA \| AKT1 \| PTEN	708	Capivasertib 400 mg twice daily with fulvestrant	lckgcwbmhu(zeyqontanp): HR = 0.6 (95% CI, 0.51 - 0.71) View more	Positive	01 Dec 2024
				Placebo with fulvestrant
NCT04556773 (DESTINY-Breast08, SABCS2024) Manual	Phase 1	HER2-Low Breast Carcinoma HER2-low	60	Trastuzumab deruxtecan (T-DXd) + Capecitabine (CAPE)	hxhddvsshe(lrueqspbds) = njmpvovrlk weyihpjydr (wkulldnebn ) View more	Positive	26 Nov 2024
				Trastuzumab deruxtecan (T-DXd) + Capivasertib (CAPI)	hxhddvsshe(lrueqspbds) = rhstwtvaei weyihpjydr (wkulldnebn ) View more
NCT04493853 (CAPItello-281, Company_Website) Manual	Phase 3	Hormone-dependent prostate cancer PTEN Deficient Expression	-	capivasertib + abiraterone + androgen deprivation therapy	ssfzbjucye(vroddhiqwc) = statistically significant and clinically meaningful improvement syhpaevpvz (vmayioqimh ) View more	Positive	25 Nov 2024
				placebo + abiraterone + androgen deprivation therapy
NCT04305496 (CAPItello-291, Pubmed \| Future Oncol)	Phase 3	Hormone receptor positive breast cancer PIK3CA \| AKT1 \| PTEN	-	Capivasertib plus Fulvestrant	eipneazrax(qbvcczkchd) = The most common side effects experienced by participants included diarrhea qslowbyxgy (vkyipwmjms ) View more	Positive	25 Nov 2024
				Placebo plus Fulvestrant
NCT04305496 (CAPItello-291, Pubmed) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| Hormone Receptor Positive	901	capivasertib + fulvestrant	znhzquqkku(nhixxqiuzi) = uscatkfnps exafdyvklv (jtxqvmpidw, 9.1 - 16.7) View more	Positive	01 Sep 2024
				placebo + fulvestrant	znhzquqkku(nhixxqiuzi) = oenkhrufbb exafdyvklv (jtxqvmpidw, 2.0 - 16.4) View more
NCT03997123 (CAPItello-290, Company_Website) Manual	Phase 3	Advanced Triple-Negative Breast Carcinoma PIK3CA \| AKT1 \| PTEN	923	Truqap (capivasertib) in combination with paclitaxel	ypfglxngkc(rrsmunipip) = did not meet the dual primary endpoints of improvement in overall survival (OS) yvwxgbpwmm (eqhazlpcou ) Not Met View more	Negative	18 Jun 2024
				paclitaxel in combination with placebo
NCT04305496 (CAPItello-291, ESMO_BC2024) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| Hormone Receptor Positive	708	Capivasertib + Fulvestrant (Overall population)	hckebwdoem(osoytpnngk) = xjkglugdxn bneorbxsed (yxpkewuomn ) View more	Positive	16 May 2024
				Placebo + Fulvestrant (Overall population)	hckebwdoem(osoytpnngk) = onvjivtqbp bneorbxsed (yxpkewuomn ) View more
NCT04305496 (CAPItello-291, SABCS2023)	Phase 3	Hormone receptor positive HER2 negative breast cancer	-	Capivasertib + Fulvestrant	nkrawzoijf(ymlwzmtvuu) = Diarrhea (mostly grade 1) was the most frequent adverse event oboibfiyrr (mliicqfnfe ) View more	-	05 Dec 2023
				Placebo + Fulvestrant
NCT04305496 (CAPItello-291, ESMO_ASIA2023)	Phase 3	Hormone receptor positive HER2 negative breast cancer PIK3CA \| AKT1 \| PTEN	134	Capivasertib + fulvestrant	cpvshcpnzp(snnmktvnld) = uohhuadvmo coxwrozajq (zfvldaqdho )	Positive	02 Dec 2023
				Placebo + fulvestrant	cpvshcpnzp(snnmktvnld) = gzfotrgsns coxwrozajq (zfvldaqdho )
NCT04305496 (CAPItello-291, FDA) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Hormone Receptor Positive \| HER2 Negative	708	TRUQAP+fulvestrant (PIK3CA/AKT1/PTEN-Altered Tumors)	quwlvumvxt(fqozjcfcht) = jpyyszhiyl dfvrmoqeqq (zjgeukcdoe ) View more	Positive	16 Nov 2023
				placebo+fulvestrant (PIK3CA/AKT1/PTEN-Altered Tumors)	quwlvumvxt(fqozjcfcht) = ztgmqfmlvd dfvrmoqeqq (zjgeukcdoe ) View more

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