AstraZeneca will highlight momentum of practice-changing cancer medicines across its robust pipeline at ASCO 2023

Tagrisso plenary presentation will demonstrate significantly improved overall survival for patients with early-stage resectable EGFR-mutated lung cancer. Enhertu will show potential across a broad range of advanced HER2-expressing advanced cancers. Lynparza and Imfinzi combination will demonstrate delay in progression in newly diagnosed advanced ovarian cancer without a tumour BRCA mutation.

AstraZeneca advances its ambition to revolutionise cancer care with new data across its industry-leading portfolio of cancer medicines at the American Society of Clinical Oncology (ASCO) Annual Meeting, 2 to 6 June 2023.

More than 130 abstracts will feature 22 approved and potential new medicines across the Company’s diverse oncology portfolio and pipeline, including 11 oral presentations and a late-breaking plenary presentation of overall survival (OS) results from the ADAURA Phase III trial of Tagrisso (osimertinib) in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) lung cancer.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Our unwavering commitment to continually raising the standard of cancer care for patients with high unmet needs is evident in our data at ASCO this year. With our leading portfolio of medicines in lung cancer, our ambition is to have the right AstraZeneca medicine for more than half of all patients with this disease by 2030. We will showcase significant steps toward that goal with overall survival data from ADAURA that reinforce Tagrisso as the backbone therapy in EGFR-mutated lung cancer.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “We are extending the benefits of our practice-changing cancer medicines, including Tagrisso, Imfinzi and Lynparza, while also investing in new scientific platforms such as T-cell engagers and cell therapy to attack cancer from multiple angles and advance the next wave of options for patients. At ASCO, the extraordinary momentum for our antibody drug conjugate collaboration portfolio continues with data for Enhertu underscoring its potential across many HER2-expressing tumour types beyond breast, lung and gastric, and updated results for datopotamab deruxtecan that reinforce our confidence in this TROP2-directed treatment.”

Improving outcomes across lung cancer settings

A late-breaking plenary presentation will showcase OS results from the ADAURA Phase III trial evaluating Tagrisso in early-stage (IB, II and IIIA) EGFR-mutated non-small cell lung cancer (NSCLC).

Several posters will describe trials-in-progress of Imfinzi (durvalumab) that further reinforce the Company’s progress toward moving lung cancer treatment to earlier stages of disease. These include NeoCOAST-2 evaluating Imfinzi in multiple novel immunotherapy combinations in resectable, early-stage NSCLC; PACIFIC-4 in combination with standard of care stereotactic body radiation therapy in medically unresectable Stage I/II NSCLC; PACIFIC-8 in combination with anti-TIGIT monoclonal antibody domvanalimab in unresectable Stage III NSCLC; and PACIFIC-9 in combination with novel immunotherapies oleclumab or monalizumab in patients with unresectable Stage III NSCLC.

Additionally, several presentations and posters will highlight the Company’s commitment to improving outcomes in advanced lung cancer with next-wave treatments and novel combinations. These include:

• An oral presentation of updated results from the TROPION-Lung02 Phase Ib dose escalation and expansion trial of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in patients with previously untreated or pretreated, advanced or metastatic NSCLC without actionable genomic alterations. TROPION-Lung02 is the first trial to show results for an antibody drug conjugate (ADC) plus an immune checkpoint inhibitor combination with or without chemotherapy in this setting.

• Interim results from the ARTEMIDE-01 Phase I trial assessing rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, in patients with advanced or metastatic NSCLC. The Company is advancing rilvegostomig into Phase III development this year.

• A trial-in-progress poster describing the EGRET Phase I trial, a first-in-human study evaluating AZD9592, an EGFR/cMET bispecific ADC, in patients with advanced solid tumours including in combination with Tagrisso in metastatic EGFRm NSCLC. This is the Company’s first bispecific ADC to enter the clinic and has shown a promising efficacy and safety profile in preclinical models.

• A trial-in-progress poster describing the LATIFY Phase III trial of ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, plus Imfinzi in patients with locally advanced or metastatic NSCLC who progressed on or after anti-PD-(L)1 and platinum-based therapy. This combination has previously demonstrated promising efficacy in this setting in the ongoing HUDSON Phase II trial.

• A trial-in-progress poster detailing the TROPION-Lung04 Phase Ib dose escalation and expansion study of Dato-DXd in various immunotherapy combinations with or without carboplatin in patients with previously untreated advanced or metastatic NSCLC, including recently initiated cohorts with bispecific immunotherapies rilvegostomig and volrustomig.

Showcasing the potential of Enhertu across multiple HER2-expressing tumours

Several presentations will reinforce the potential of Enhertu (trastuzumab deruxtecan) in a broad range of HER2-expressing tumours with significant unmet need, including gynaecological, genitourinary, gastrointestinal and breast cancers.

A late-breaking oral presentation of interim results from the DESTINY-PanTumor02 Phase II trial will highlight the efficacy and safety of Enhertu in heavily pretreated patients across multiple HER2-expressing advanced solid tumours including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and rare cancers. In March, Enhertu met the prespecified target for objective response rate and demonstrated durable responses across multiple HER2-expressing tumour types in this trial.

Additionally, an oral presentation of primary results from the DESTINY-CRC02 Phase II trial will be presented, demonstrating the safety and efficacy of Enhertu in patients with HER2-positive advanced colorectal cancer with progression following standard-of-care treatment. This trial was initiated based on positive data for Enhertu in the DESTINY-CRC01 Phase II trial.

Another oral presentation will feature a pooled benefit-risk analysis from the DESTINY-Breast01, 02 and 03 trials of Enhertu in patients with breast cancer aged 65 and older compared to those younger than 65.

Potential to transform outcomes across tumours by attacking cancer from multiple angles

A late-breaking oral presentation will feature interim progression-free survival (PFS) results from the DUO-O Phase III trial evaluating a combination of Lynparza, Imfinzi, chemotherapy and bevacizumab in newly diagnosed patients with advanced high-grade epithelial ovarian cancer without tumour BRCA mutations. In April, it was announced that DUO-O demonstrated a statistically significant and clinically meaningful improvement in PFS for this Lynparza and Imfinzi combination versus chemotherapy plus bevacizumab alone.

Data will be also shared from a post-hoc exploratory analysis of the SERENA-2 Phase II trial in patients with advanced ER-positive breast cancer who have disease recurrence or progression after endocrine therapy. The analysis will show PFS data for patients treated with next-generation selective estrogen receptor degrader (ngSERD) camizestrant versus Faslodex (fulvestrant) based on the type of ESR1 mutation at baseline, detected via circulating tumour DNA. Previously presented primary results from SERENA-2 demonstrated PFS benefit with camizestrant irrespective of ESR1 mutation status or prior treatment with CDK4/6 inhibitors.

Data will also be shared from a matching-adjusted indirect comparison (MAIC) of the efficacy and safety of Calquence (acalabrutinib) versus zanubrutinib in relapsed or refractory chronic lymphocytic leukemia, based on data from the ASCEND and ALPINE Phase III trials.

In addition, interim Phase I results evaluating AZD0486 (TNB-486), a CD19/CD3 next-generation T-cell engager, will show the potential of targeting CD19 in heavily pretreated patients with follicular lymphoma.

Results from a Phase Ib/II dose escalation and expansion trial of the novel immunotherapy oleclumab in combination with Imfinzi and chemotherapy will also be presented in patients with metastatic pancreatic cancer, including those with high levels of CD73 expression.

A poster discussion will feature health-related quality-of-life results from the PROpel Phase III trial of Lynparza plus abiraterone in patients with metastatic castration-resistant prostate cancer.

Two presentations will focus on immune-mediated adverse events (imAEs) in the HIMALAYA Phase III trial of Imfinzi plus Imjudo (tremelimumab) in 1st-line unresectable liver cancer, including an oral presentation on outcomes by imAE occurrence and a poster on temporal patterns of imAE occurrence.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and datopotamab deruxtecan; with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza. AstraZeneca obtained full oncology rights to monalizumab from Innate Pharma in October 2018 through a co-development and commercialisation agreement initiated in 2015.

Key AstraZeneca presentations during ASCO 2023

Notes

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

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

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

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