FLAURA2 data reinforce Tagrisso as backbone therapy for EGFR-mutated advanced lung cancer in combination with chemotherapy; granted Breakthrough Therapy Designation in the US. Further results for Enhertu, Imfinzi and datopotamab deruxtecan showcase strength of diverse ADC and IO portfolios to address unmet needs.

AstraZeneca advances its robust lung cancer portfolio and pipeline at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC), 9 to 12 September 2023.

More than 40 abstracts will feature eight approved and potential new medicines from AstraZeneca, including nine oral presentations and a late-breaking plenary Presidential Symposium presentation of results from the FLAURA2 Phase III trial of Tagrisso (osimertinib) in combination with chemotherapy for patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) lung cancer.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Our data at WCLC support our ambition to have the right AstraZeneca medicine for more than half of all patients treated for lung cancer by 2030, and underscore the need to increase screening and early diagnosis to improve patient outcomes. The strong results from FLAURA2 will further establish Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer, and the recent Breakthrough Therapy Designation in the US is a significant validation of the potential we see for this regimen.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Following last year’s accelerated approval of Enhertu as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic lung cancer, new data at WCLC will reinforce its potential benefit to patients in need of targeted options. In addition, data for datopotamab deruxtecan will further support the potential to combine this agent with immune checkpoint inhibitors and the continued investigation of these combinations in first-line settings.”

Improving outcomes across early- and late-stage EGFRm lung cancer
A late-breaking plenary Presidential Symposium presentation will showcase progression-free survival (PFS) data from the FLAURA2 Phase III trial evaluating Tagrisso in combination with chemotherapy for patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm non-small cell lung cancer (NSCLC). In May, high-level results showed the Tagrisso combination demonstrated a statistically significant and clinically meaningful improvement in PFS compared to standard-of-care Tagrisso monotherapy. In August, Tagrisso plus chemotherapy was granted Breakthrough Therapy Designation in the US for advanced EGFRm NSCLC.

An oral presentation of results from a Phase IIIb trial will show the potential of Orpathys (savolitinib) as a 1st-line treatment for advanced or metastatic NSCLC harbouring MET exon 14 mutations. Orpathys is approved for this indication in China.

In addition, an e-poster on a computational pathology analysis of MET expression in patients treated with a combination of Orpathys and Tagrisso in the SAVANNAH Phase II trial will showcase the Company’s progress in developing transformational technology solutions to identify patients who are most likely to respond to treatment. Encouraging efficacy for the combination has been previously reported in the same study in patients with high levels of MET overexpression and/or amplification whose disease progressed on treatment with Tagrisso.

Realising the potential of antibody drug conjugates (ADCs) in advanced lung cancer
A late-breaking oral presentation of first results from the TROPION-Lung04 Phase Ib trial will highlight the safety and efficacy of datopotamab deruxtecan (Dato-DXd) plus Imfinzi (durvalumab) with and without carboplatin in patients with previously treated or untreated, advanced or metastatic NSCLC without actionable genomic alterations. There are currently no TROP2-directed ADCs approved for the treatment of patients with lung cancer.

A mini-oral presentation of primary results from the DESTINY-Lung02 Phase II trial will share the first overall survival and PFS data for Enhertu (trastuzumab deruxtecan) in patients with previously treated HER2-mutant metastatic NSCLC. Enhertu is approved for this indication in a number of countries, including in the US, where it was granted accelerated approval based on interim results from the trial.

Two posters will feature AZD9592, an EGFR/cMET bispecific ADC designed to deliver targeted chemotherapy to cancer cells expressing both EGFR and cMET with a topoisomerase inhibitor 1 warhead using the Company’s proprietary linker technology. A trial-in-progress poster will describe the EGRET Phase I trial, a first-in-human study evaluating AZD9592 in patients with advanced solid tumours including in combination with Tagrisso in metastatic EGFRm NSCLC. In addition, a poster on translational results for AZD9592 suggests it may provide clinical benefit in areas of unmet need, including in patients with NSCLC previously treated with chemotherapy or targeted agents. This is the Company’s first bispecific ADC to enter the clinic.

Reinforcing Imfinzi benefits alone and in novel combinations across lung cancer settings
Two late-breaking oral presentations will share new data from the AEGEAN Phase III trial of Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery in patients with resectable NSCLC, including key surgical outcomes and exploratory analyses of clinical outcomes in a subset of patients with EGFRm disease. Previously presented primary results from AEGEAN demonstrated statistically significant and clinically meaningful improvement in event-free survival and pathologic complete response with this Imfinzi-based regimen versus neoadjuvant chemotherapy alone followed by surgery.

Another oral presentation of data from a planned subset analysis of the PACIFIC-R observational study of Imfinzi in a real-world population of patients with EGFRm disease will explore the long-term clinical outcomes of Imfinzi in patients with unresectable, Stage III NSCLC.

Data will also be shared from new exploratory subgroup analyses of the POSEIDON Phase III trial describing patients deriving long-term benefit from the combination of Imfinzi, Imjudo (tremelimumab) and chemotherapy in the metastatic NSCLC setting.

Advancing our commitment to increase lung cancer screening and early diagnosis
An oral presentation will describe a framework to support government implementation of high-quality and impactful lung cancer screening programmes. Screening is essential to early detection and reducing lung cancer mortality. Published in March 2023, the framework was developed by the Lung Cancer Policy Network, an initiative of the Lung Ambition Alliance aimed at elevating lung cancer as a policy priority worldwide. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

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, and with HUTCHMED to develop and commercialise Orpathys.

Key AstraZeneca presentations during WCLC 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 social media @AstraZeneca.

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