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

Pressmeddelande   •   Sep 16, 2019 08:13 CEST

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

Lead author Abstract title Presentation details
Lung cancer
Ramalingam, S FLAURA: Phase III trial of osimertinib compared with previous standard-of-care treatments for patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC, including those with central nervous system (CNS) metastases Abstract #LBA5_PR Oral Presentation - Presidential Symposium I Saturday 28 September,

17:56 - 18:08

Barcelona Auditorium (Hall 2)

Paz-Ares, L CASPIAN: A Phase III trial of durvalumab in combination with standard-of-care (SoC) chemotherapy options vs. SoC in 1st-line extensive-stage small cell lung cancer (SCLC) Abstract #LBA89 Proffered Paper 1 - Non-metastatic NSCLC and other thoracic malignancies (SCLC) Saturday 28 September,

16:30 - 16:42

Cordoba Auditorium (Hall 7)

Vansteenkiste, J PACIFIC: Efficacy of durvalumab in patients with Stage III unresectable NSCLC who experience pneumonitis Abstract #1459PD Poster Discussion - Non-metastatic NSCLC and other thoracic malignancies Sunday 29 September,

8:55

Sevilla Auditorium (Hall 2)

Sheth, S Durvalumab activity in previously treated patients who stopped durvalumab without disease progression Abstract #1175O Proffered Paper - Immunotherapy of cancer

Monday 30 September,

11:00 – 11:15

Barcelona Auditorium (Hall 2)

Metro, G ASTRIS: A Phase III trial of osimertinib in the real world setting in patients with advanced or metastatic, of EGFR T790M advanced NSCLC patients with CNS metastases Abstract #1521P Poster Presentation - Session 1

Saturday 28 September,

12:00

Poster Area (Hall 4)

Ovarian cancer
Ray-Coquard, I PAOLA-1: A Phase III trial of olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer treated with platinum-based chemotherapy plus bevacizumab Abstract #LBA2_PR Oral Presentation - Presidential Symposium I

Saturday 28 September,

16:42 - 16:54

Barcelona Auditorium (Hall 2)

Oaknin, A SOLO-1: Time to second progression and second subsequent therapy for patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation treated with maintenance olaparib Abstract #995PD Poster Discussion - Gynaecological cancers

Sunday 29 September,

10:30

Valencia Auditorium (Hall 5)

Friedlander, M SOLO-1: Patient-centered outcomes with maintenance olaparib in newly diagnosed patients with advanced ovarian cancer and a BRCA mutation in the Phase III SOLO1 trial to support the clinical benefit of prolongation of progression-free survival Abstract #996PD Poster Discussion - Gynaecological cancers

Sunday 29 September,

10:30

Valencia Auditorium (Hall 5)

Gourley, C Analysis of tumour samples from SOLO1: frequency of BRCA specific loss of heterozygosity (LOH) and progression-free survival (PFS) according to homologous recombination repair deficiency (HRD)-LOH score Abstract #998PD Poster Discussion - Gynaecological cancers

Sunday 29 September,

11:00

Valencia Auditorium (Hall 5)

Drew, Y MEDIOLA: Phase II study of olaparib and durvalumab (MEDIOLA): Updated results in germline BRCA-mutated platinum sensitive relapsed (PSR) ovarian cancer (OC) Abstract #1190PD Poster Discussion - Gynaecological cancers

Sunday 29 September,

10:30

Valencia Auditorium (Hall 5)

Colombo, N BAROCCO: A randomized phase II study of weekly paclitaxel vs. cediranib-olaparib combination given with continuous or intermittent schedule in patients with recurrent platinum resistant ovarian cancer (PROC) Abstract #LBA58 Proffered Paper 1 - Gynaecological cancers

Friday 27 September

16:00 - 16:15

Pamplona Auditorium (Hall 2)

Other tumour types
Hussain, M PROfound: A Phase III study of the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer and homologous recombination repair gene mutations Abstract #LBA12_PR Oral Presentation Presidential Symposium III

Monday 30 September,

17:09 - 17:21

Barcelona Auditorium (Hall 2)

Hammel, P POLO: Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer who received maintenance olaparib Abstract #675PD Poster Discussion - Gastrointestinal tumours, non-colorectal

Saturday 28 September,

16:50

Tarragona Auditorium (Hall 7)

Van Cutsem, E POLO: Time to treatment discontinuation and subsequent therapies following maintenance olaparib for patients with a germline BRCA mutation and metastatic pancreatic cancer Abstract #693P Poster Display - Session 2 Sunday 29 September

12:20

Poster Area (Hall 4)

Dillon, M PATRIOT (Part A, B): A Phase I study of ATR inhibitor, AZD6738, as monotherapy in advanced solid tumours. Preliminary results Abstract #450PD Poster Discussion - Developmental therapeutics

Saturday 28 September,

17:14

Alicante Auditorium (Hall 3)

Powles, T BISCAY: An adaptive, biomarker directed platform study in metastatic urothelial cancer with durvalumab in combination with targeted therapies Abstract #902O Proffered Paper 1 - Genitourinary tumours, non-prostate

Saturday 28 September,

9:30 - 9:45

Barcelona Auditorium (Hall 2)

Cho, M A Phase I/II trial of durvalumab plus monalizumab, mFOLFOX6, and bevacizumab in patients with metastatic microsatellite-stable colorectal cancer Abstract #1201P Poster Display - Session 3 Monday 30 September,

12:00

Poster Area (Hall 4)

Domchek, S Phase II study of olaparib (O) and durvalumab (D) (MEDIOLA): Updated results in patients (pts) with germline BRCA-mutated (gBRCAm) metastatic breast cancer (MBC) Abstract #1191O Proffered Paper Session - Immunotherapy of cancer

Monday 30 September,
11:15 - 11:30

Barcelona Auditorium (Hall 2)

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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Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden: cancer, kardiovaskulära sjukdomar, njursjukdomar och metabola sjukdomar och sjukdomar i andningsvägarna. Bolaget är också selektivt aktivt inom autoimmunitet, neurovetenskap och infektion. AstraZeneca bedriver verksamhet i över 100 länder och dess innovativa läkemedel används av miljontals patienter över hela världen.

Mer information finns på: www.astrazeneca.com och www.astrazeneca.se. Du kan även följa oss på twitter https://twitter.com/AstraZenecaSE

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