AstraZeneca aims to transform cancer treatment and advance clinical practice with data presented at ESMO 2020

Pivotal overall survival data confirm benefit of Lynparza use in advanced prostate cancer

Data in early treatment of lung cancer highlight potential to improve patient outcomes in curative-intent settings with Tagrisso and Imfinzi

AstraZeneca will present new developments in pursuit of its ambition to eliminate cancer as a cause of death at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, 19 to 21 September.

AstraZeneca medicines and pipeline molecules feature in 114 abstracts at ESMO, a record for the Company, including 20 oral presentations and two Presidential Symposia. The data highlight the breadth of the portfolio of cancer medicines and the early-stage pipeline. Whether it is by treating cancer early or by developing tailored medicines across all stages of disease, these data have the potential to transform patient outcomes and survival.

Key presentations include:

·       Practice-changing overall survival (OS) data from the PROfound Phase III trial presented in a Presidential Symposium confirming the long-term benefit of Lynparza (olaparib) in biomarker-selected patients with metastatic castration-resistant prostate cancer (mCRPC)

·       Exploratory data from the ADAURA Phase III trial showing further support for the unprecedented patient benefit of Tagrisso (osimertinib) in the adjuvant treatment of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) also presented in a Presidential Symposium

·       Data from the PACIFIC Phase III trial in unresectable Stage III NSCLC and the CASPIAN Phase III trial in extensive-stage small-cell lung cancer (ES-SCLC), two late-breaking presentations strengthening the Company’s leadership in the treatment of lung cancer

José Baselga, Executive Vice President, Oncology R&D, said: “The data being presented at ESMO will reshape clinical practice in the months and years ahead. The final PROfound overall survival data show the power of biomarker-directed medicines in prostate cancer, while the ADAURA and PACIFIC data reflect our continued focus on early detection, interception and treatment of cancer. We continue to work with urgency throughout this extraordinary period to accelerate the development of medicines in our pipeline, turning innovative science into improved outcomes for patients.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Our data at ESMO reflect our vision to transform the cancer treatment landscape, achieving more durable outcomes, treating with curative intent, and changing what it means to live with and beyond a cancer diagnosis. Our ability to detect and treat cancer early is key in bringing new treatment options to later stages of disease. We are eager to translate our pivotal research into clinical practice and help patients live better, longer lives.”

Redefining treatment options for advanced disease across tumour types

One Presidential Symposium will present the final OS analysis of the PROfound Phase III trial of Lynparza versus enzalutamide or abiraterone in patients with mCRPC and homologous recombination repair (HRR) gene mutations, including BRCA, ATM, CDK12 and 11 other HRR genes.

Beyond the PROfound trial, a presentation of five-year follow-up data from the SOLO-1 Phase III trial will highlight the sustained progression-free and recurrence-free survival benefits of Lynparza for patients with newly diagnosed BRCA-mutated advanced ovarian cancer. These exploratory analyses are the longest follow-up for any PARP inhibitor in this setting and expand on the positive SOLO-1 results previously published in The New England Journal of Medicine and presented at the ESMO 2018 Congress.

In addition, a late-breaking presentation of data from the PAOLA-1 Phase III trial will demonstrate that the addition of maintenance Lynparza to bevacizumab, a standard treatment, significantly improved the time to second disease progression (PFS2) compared with bevacizumab alone in patients with advanced ovarian cancer with homologous recombination deficiency positive status (defined by BRCA mutation and/or genomic instability). PFS2 is a key secondary endpoint in the PAOLA-1 trial and reinforces the positive results previously published in The New England Journal of Medicine and presented at the ESMO 2019 Congress.

Leadership in early lung cancer treatment

A second Presidential Symposium will present exploratory data from the ADAURA Phase III trial highlighting the impact of treatment with Tagrisso on sites and types of disease recurrence, including brain metastases, in patients with early-stage (Stages IB-IIIA) EGFRm NSCLC. Tagrisso was recently granted Breakthrough Therapy Designation in this setting in the US.

Data will also be presented from the PACIFIC and CASPIAN Phase III trials highlighting the long-term benefit of Imfinzi across different types of lung cancer. These include a presentation of four-year OS data in patients with unresectable Stage III NSCLC who had not progressed following concurrent chemoradiation therapy and a presentation of updated data in ES-SCLC.

Progressing the pipeline - pushing boundaries, advancing combinations

Exploratory data from the DESTINY-Gastric01 Phase II trial will show the results of Enhertu (trastuzumab deruxtecan) in patients with metastatic gastric cancer and low expression of HER2.

The DANUBE Phase III trial will be presented in an oral presentation showing the results for Imfinzi with and without tremelimumab in patients with advanced bladder cancer, including analyses of patients with high PD-L1 expression. The trial did not meet its primary endpoints.

AstraZeneca will also present data from several trials of the early and mid-stage pipeline, including:

·       A Phase II trial of Lynparza plus Imfinzi and bevacizumab (MEDIOLA): initial results in patients with non-germline BRCA-mutated platinum sensitive relapsed ovarian cancer

·       A Phase lb expansion trial of adavosertib plus Lynparza in patients with ES or relapsed SCLC

Collaboration in the scientific community is critical to improving outcomes for patients. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. in the US and Canada). AstraZeneca is collaborating with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialise Enhertu.

Key AstraZeneca presentations during the ESMO Virtual Congress 20201

Lead author

Abstract title

Presentation details

Immuno-Oncology

 

Goldman, J

Durvalumab (D) ± tremelimumab (T) + platinum-etoposide (EP) in 1L ES-SCLC: Characterization of long-term clinical benefit and tumour mutational burden (TMB) in CASPIAN

Abstract #LBA86

Mini Oral Session – Non-metastatic NSCLC and other thoracic malignancies

Faivre-Finn, C

Durvalumab after chemoradiotherapy in Stage III NSCLC: 4-year survival update from the Phase 3 PACIFIC trial

Abstract #LBA49

Mini Oral Session – Non-metastatic NSCLC and other thoracic malignancies

Powles, T

A phase 3, randomized, open-label study of first-line durvalumab (D) with or without tremelimumab (T) vs standard of care chemotherapy in patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE)

Abstract #697O

Proffered Paper Session – Genitourinary Tumours, Non-Prostate

Saturday September 19

16:20 – 18:00 CEST

Channel 3

DNA damage response

 

Ray-Coquard, I

Maintenance olaparib + bevacizumab (bev) in patients (pts) with newly diagnosed advanced high-grade ovarian cancer (HGOC): RECIST and/or CA-125 objective response rate (ORR) in the Phase III PAOLA-1 trial

Abstract #812MO

Mini Oral Session – Gynaecological Cancers

Banerjee, S

Maintenance olaparib for patients (pts) with newly diagnosed, advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): 5-year (y) follow-up (f/u) from SOLO1

Abstract #811MO

Mini Oral Session – Gynaecological Cancers

Drew, Y

Phase II study of olaparib (O) plus durvalumab (D) and bevacizumab (B) (MEDIOLA): initial results in patients (pts) with non-germline BRCA-mutated (non-gBRCAm) platinum sensitive relapsed (PSR) ovarian cancer (OC)

Abstract #814MO

Mini Oral Session – Gynaecological Cancers

De Bono, J

Final overall survival (OS) analysis of PROfound: olaparib vs physician’s choice of enzalutamide or abiraterone in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations

Abstract #610O

Presidential Symposium II

Saturday 20 September

19:14 – 19:26 CEST

Channel 1

Roubaud, G

Tolerability of olaparib (OLA) in patients (pts) with metastatic castrationresistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: PROfound

Abstract #624P

E-Poster Display Session

Agarwal, N

Exploring the impact of treatment switching on the interim overall survival (OS) results of the PROfound study

Abstract #622P

E-Poster Display Session

Hauke, J

Germline mutation status and therapy response in patients with homologous recombination deficient, HER2-negative early breast cancer: Results of the GeparOLA study (NCT02789332)

Abstract #176P

E-Poster Display Session

Hochhauser, D

Assessing clinical benefit of olaparib maintenance treatment in subgroups of patients with germline BRCA mutation (gBRCAm) and metastatic pancreatic cancer: phase III POLO trial

Abstract #1527P

E-Poster Display Session

Li, B

Phase Ib expansion study of adavosertib plus olaparib in patients with extensive-stage or relapsed small-cell lung cancer

Abstract #1785P

E-Poster Display Session

Tumour drivers and resistance

 

Tsuboi, M

Osimertinib adjuvant therapy in patients (pts) with early stage EGFR mutated (EGFRm) NSCLC after tumour resection (ADAURA): sites of disease recurrence

Abstract #LBA1

Presidential Symposium I

Saturday, 19 September

18:30 – 18:42 CEST

Channel 1

Planchard, D

Osimertinib plus platinum/pemetrexed in newly-diagnosed EGFR mutation (EGFRm)-positive advanced NSCLC: safety run-in results from the FLAURA2 study

Abstract #1401P

E-Poster Display Session

Cheng, Y

Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC: FLAURA China study overall survival

Abstract #1295P

E-Poster Display Session

Subramanian, J

Epidermal growth factor receptor mutation (EGFRm) testing in advanced non-small cell lung cancer (aNSCLC) in a real-world setting

Abstract #1402P

E-Poster Display Session

Hummel, M

FACILITATE: a real-world multicentre prospective study investigating the utility of a rapid, fully automated RT-PCR assay vs reference methods (RM) for detecting epidermal growth factor receptor mutations (EGFRm) in NSCLC

Abstract #1205P

E-Poster Display Session

Antibody drug conjugates

Yamaguchi, K

Trastuzumab deruxtecan in patients with HER2

low, advanced gastric or gastroesophageal junction adenocarcinoma: results of the exploratory cohorts in the phase 2, multicenter, open label DESTINY-Gastric01 study

Abstract #1422MO

Mini Oral Session – Gastrointestinal tumours, non-colorectal

Modi, S

Artificial intelligence analysis of advanced breast cancer patients from a phase I trial of trastuzumab deruxtecan (T-DXd): HER2 and histopathology features as predictors of clinical benefit

Abstract #286P

E-Poster Display Session

 

Powell, C

Risk factors for interstitial lung disease in patients treated with trastuzumab deruxtecan from two interventional studies

Abstract #289P

E-Poster Display Session

Janjigian, YY

A phase 1b/2, multicenter, open label, dose escalation and dose expansion study evaluating trastuzumab deruxtecan monotherapy and combinations in patients with HER2 overexpressing gastric cancer (DESTINY-Gastric03)

Abstract #1500TiP

E-Poster Display Session

1 114 abstracts at ESMO 2020 include AstraZeneca medicines and pipeline molecules, of which 75 are company sponsored or supported.

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 seven new medicines 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.

By harnessing the power of six scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies - 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.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) 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 & 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.

Contacts

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

 

tags

  • Cancer