AstraZeneca redefines cancer treatment with practice-changing data at ESMO 2019

Pivotal Phase III data focuses on improving overall survival across lung cancers and breaking treatment boundaries in ovarian, prostate and pancreatic cancers

AstraZeneca will unveil a series of breakthrough data across multiple cancer types in its mission to one day eliminate cancer as a cause of death at the European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, 27 September to 1 October 2019.

With 63 abstracts, including 7 oral presentations, the Company will demonstrate its leadership in precision medicine and immunotherapy. Highlights include results of three Phase III clinical trials featured in the ESMO Presidential Symposia across three cancer types:

• In lung cancer, new data from the Phase III FLAURA trial will highlight the superior overall survival (OS) benefit of Tagrisso (osimertinib) compared with previous standard-of-care (SoC) treatments erlotinib or gefitinib for patients with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC) (Abstract #LBA5_PR). FLAURA is the first and only global Phase III trial to demonstrate a statistically-significant OS benefit in this setting.
• In ovarian cancer, progression-free survival (PFS) results from the Phase III PAOLA-1 trial, including key subgroup analysis, will illustrate the benefit of adding Lynparza (olaparib) to SoC bevacizumab in the 1st-line maintenance treatment of women with advanced ovarian cancer (Abstract #LBA2_PR). PAOLA-1 is the second positive Phase III trial for Lynparza in 1st-line advanced ovarian cancer.
• In metastatic castration-resistant prostate cancer (mCRPC), results from the Phase III PROfound trial will detail the improvements in radiographic PFS observed with Lynparza. Patients in the trial had progressed on prior treatment with new hormonal anticancer treatments and had mutations in homologous recombination repair (HRR) genes, such as BRCA1/2 and ATM, which are a common trait in cancer cells that can interfere with normal cell DNA repair mechanisms (Abstract #LBA12_PR). These data show the value of genomic testing beyond just BRCAm and make Lynparza the first PARP inhibitor to achieve positive Phase III results in four different cancer types (breast, ovarian, pancreatic and prostate).

Dave Fredrickson, Executive Vice President, Oncology, said: “The practice-changing data we are presenting at ESMO 2019 demonstrates our commitment to make prolonged survival a realistic outcome. By using biomarkers to define optimal treatment and match innovative precision medicines to the patients who can best benefit from them, our dynamic Oncology pipeline and pioneering research continue to deliver new potential medicines across multiple deadly cancers.”

José Baselga, Executive Vice President, Oncology R&D, said: “At ESMO 2019 we will see key components of our next-generation Oncology pipeline, including innovative platform studies and early data for the next wave of therapies designed to preferentially kill cancer cells and regulate the immune response to cancer.”

Improving overall survival across lung cancers

In addition to the FLAURA OS results, key presentations include:

• Results from the Phase III CASPIAN trial showing improved OS with better quality of life for patients taking Imfinzi (durvalumab) in combination with SoC chemotherapy vs. SoC (Abstract #LBA89).
• New data from the Phase III PACIFIC trial demonstrating that treatment benefit with Imfinzi vs. placebo was maintained regardless of the occurrence of pneumonitis (Abstract #1459PD).
• An oral presentation of data from the Phase I/II 1108 study in patients with solid tumours, including NSCLC, showing that reinitiating treatment with Imfinzi restored antitumour efficacy without disease progression in previously-treated patients who had progressed after a planned treatment interruption (Abstract #1175O).
• Results from the real-world ASTRIS study of EGFR T790M mutation positive advanced NSCLC patients with central nervous system (CNS) metastases (Abstract #1521P).

Breaking treatment boundaries in ovarian cancer

In addition to the PAOLA-1 results, key presentations include:

• Subanalyses from the Phase III SOLO-1 trial of Lynparza in newly-diagnosed advanced ovarian cancer patients, assessing time to second subsequent therapy (Abstract #995PD), patient-reported outcomes (Abstract #996PD) and health-related quality of life (HRQoL) (Abstract #998PD).
• Updated results from the Phase II MEDIOLA trial of Lynparza and Imfinzi in germline BRCAm platinum-sensitive relapsed ovarian cancer (Abstract #1191PD).
• Data from the Phase II BAROCCO trial of Lynparza and cediranib with a continuous or intermittent schedule in advanced platinum-resistant ovarian cancer (Abstract #LBA58).

Establishing new therapeutic landmarks in multiple tumour types

Presentations beyond the PROfound trial results include:

• Subanalyses from the Phase III POLO trial of Lynparza in germline BRCAm metastatic pancreatic cancer patients, including HRQoL (Abstract #675PD) as well as time to treatment discontinuation and time to subsequent therapies (Abstract #693P).
• An oral presentation of data from the Phase Ib BISCAY trial, an adaptive, biomarker-directed platform study of Imfinzi in combination with multiple targeted therapies in metastatic bladder cancer (Abstract #902O).
• Preliminary results from the Phase I PATRIOT study of ATR inhibitor AZD6738 as monotherapy in advanced solid tumours (Abstract #450PD).
• Safety data from a Phase I/II trial of Imfinzi plus monalizumab, bevacizumab and SoC combination chemotherapy in patients with metastatic microsatellite-stable colorectal cancer (Abstract #1201P).
• Updated results from the MEDIOLA Phase II study of Lynparza and Imfinzi in germline BRCAm metastatic breast cancer (MBC) (Abstract #1191O).

Key AstraZeneca presentations at ESMO 2019

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca’s main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal and Metabolism (CVRM), and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow us on Twitter @AstraZeneca.

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