Lynparza (olaparib) Maintenance Treatment Offers Sustained Quality of Life alongside Improved Progression-Free Survival in Women with BRCA-Mutated Ovarian Cancer
AstraZeneca today reported new data from the Phase III SOLO-2 trial of Lynparza (olaparib) 300mg twice-daily tablet maintenance treatment showing that quality of life (QoL) is sustained alongside improved progression-free survival (PFS) in women with germline BRCA-mutated (gBRCAm), platinum-sensitive, relapsed serous ovarian cancer.1
On three separate rating scales (functional, physical well-being and symptoms), women receiving olaparib maintenance treatment reported similar QoL to those taking placebo, according to results presented at the 2017 ASCO Annual Meeting in Chicago, US, 2-6 June 2017.1 Significant ‘patient-centred benefits’ of olaparib vs placebo in quality-adjusted progression-free survival (QAPFS) and time without symptoms of disease or toxicity (TWiST) were observed up to 27 months after randomisation.
Eric Pujade-Lauraine, Head of the Women Cancers and Clinical Research Department at Hôpitaux Universitaires Paris Centre, site Hôtel-Dieu, AP-HP and Principal Investigator of SOLO-2, said: “This is very good news for patients because it suggests that olaparib not only has the potential to significantly prolong the amount of time they have before their disease progresses, but that additional time does not come at the cost of their quality of life. This may mean patients feel more able to adhere to maintenance treatment. This contrasts with what we have seen in the past with chemotherapy where the price of longer progression-free survival is often reduced quality of life leading to poor adherence to treatment.”
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The olaparib quality of life data further support the potential benefit of this first-in-class PARP inhibitor as maintenance therapy for women with BRCA-mutated relapsed serous ovarian cancer. They strengthen our confidence in targeting DNA damage response (DDR) mechanisms to selectively kill cancer cells while minimising damage to healthy tissue which may cause adverse effects that impact negatively on quality of life for patients.”
Key QoL data from SOLO-2 include:1,2
- Primary endpoint for patient-reported outcomes (FACT-O TOI): No appreciable detrimental effect on quality of life for patients receiving maintenance treatment with olaparib versus patients on placebo −2.90 vs -2.87 respectively, difference -0.03, 95% confidence interval [CI] –2.19, 2.13; P=0.98)
- Quality-adjusted progression-free survival (QAPFS): Mean 13.96 vs 7.28 months for olaparib and placebo respectively (difference 6.68; 95% CI 4.98, 8.54; P<0.0001)
- Time without symptoms of disease or toxicity (TWiST): Significant improvement for patients on olaparib maintenance (13.5 vs 7.21 months, difference 6.29; 95% CI 2.95, 8.58; P<0.0001)
These data build on previously reported results of SOLO-2 which met its primary endpoint of investigator-assessed PFS (HR 0.30; 95% CI 0.22 to 0.41; P<0.0001; median 19.1 months vs 5.5 months).2 PFS as measured by Blinded Independent Central Review (BICR) evaluation, a pre-specified analysis supporting the primary endpoint, demonstrated a median PFS of 30.2 months vs 5.5 months for placebo, representing an improvement of 24.7 months (HR 0.25; 95% CI 0.18-0.35; P<0.0001). Earlier research also suggested the potential of olaparib as maintenance therapy in relapsed ovarian cancer.3
The 300mg twice-daily tablet dose, as used in SOLO-2, potentially reduces the existing pill burden for patients from 16 capsules to four tablets per day.
The safety profile for patients treated with olaparib tablets during the trial was consistent with that observed with the currently-approved capsule formulation.2 Any adverse events (AE) Grade ≥3 were reported in 36.9% of patients treated with olaparib and in 18.2% of patients who received placebo.2 The most common non-haematological AEs reported at a frequency of ≥20% were nausea (75.9% [grade ≥3, 2.6%]), fatigue/asthenia (65.6% [grade ≥3, 4.1%]),vomiting (37.4% [≥3, 2.6%]), diarrhoea (32.8% [≥3, 1.0%]) and abdominal pain (24.1% [≥3, 2.6%).2 The incidence of serious (grade ≥3) haematological AEs were 19.5%, 5.1% and 1.0% for anaemia, neutropenia and thrombocytopenia, respectively.4
– ENDS –
NOTES TO EDITORS
SOLO-2 was a Phase III, randomised, double-blind, multicentre trial designed to investigate the efficacy of olaparib tablets as a maintenance monotherapy compared with placebo, in patients with platinum-sensitive relapsed gBRCA-mutated ovarian cancer.5 The trial, conducted in collaboration with the European Network for Gynaecological Oncological Trial Groups (ENGOT) and Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein (GINECO), randomised 295 patients with documented germline BRCA1 or BRCA2 mutations who had received at least two prior lines of platinum-based chemotherapy and were in complete or partial response to their most recent regimen.5,6 Eligible patients were randomised to receive either olaparib tablets (300mg twice daily) or placebo.5
About AstraZeneca in Ovarian Cancer
Worldwide, ovarian cancer is the 7th most-commonly diagnosed cancer and the 8th most common cause of cancer death in women.7,8 The risk of developing ovarian cancer is increased in women with specific inherited genetic abnormalities, including BRCA mutations.9 AstraZeneca is committed to the continued development of our R&D portfolio for ovarian cancer, with a focus on improved care for all patients, including the development of targeted therapies for patients with specific gene mutations such as BRCA.
About Lynparza (olaparib)
Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells.10,11,12,13 It is approved by regulatory authorities in the EU and US for the treatment of women with BRCAm ovarian cancer.10,11 Olaparib is the foundation of AstraZeneca’s industry-leading portfolio of potential medicines targeting DNA damage response (DDR) mechanisms in cancer cells.
ENGOT (European Network for Gynaecological Oncological Trial groups) is a research network of the European Society of Gynaecological Oncology (ESGO) and was founded in 2007. Currently, ENGOT consists of 19 cooperative groups from 15 European countries. ENGOT's ultimate goal is to bring the best treatment to gynaecological cancer patients through the best science, and enable every patient in every European country to access a clinical trial. ENGOT coordinates and promotes multinational clinical trials within Europe for patients with gynaecological cancer. This coordination is particularly relevant for academic clinical trials, translational research, research on rare diseases, and for clinical trials sponsored by the pharmaceutical industry.14
GINECO (Groupe d’Investigateurs National pour l’Etude des Cancers de l’Ovaire et du sein) is the French Cooperative Group in Oncology labelled by INCA (Institut National du Cancer or French NCI) for developing and conducting gynaecological and advanced breast cancer clinical trials at the national and international level. The network is nationwide, with over 500 specialised investigators belonging to more than 150 public or private oncology units. The GINECO group was founded in 1993 and is a member of international consortia such as ENGOT and GCIG (Gynecologic Cancer InterGroup). GINECO was the ENGOT leading group for the SOLO-2 trial.6
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, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our 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.
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 main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
This press release is issued from the AstraZeneca Corporate Headquarters in Cambridge, UK and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where AstraZeneca conducts business.
1. Friedlander M., et al. Relationship of health-related quality of life (HRQOL) and patient-centered outcomes with the clinical outcomes with olaparib maintenance following chemotherapy in patients with germline (g) BRCA-mutated (m) platinum-sensitive relapsed serous ovarian cancer (PSR SOC): SOLO2 phase III trial. Presented at the American Society of Clinical Oncology (ASCO), June 2 – 6, 2017. Chicago, Illinois, US
2. Pujade-Lauraine E., et al. Treatment with olaparib monotherapy in the maintenance setting significantly improves progression-free survival in patients with platinum-sensitive relapsed ovarian cancer: Results from the Phase III SOLO2 Study. Presented at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO), March 12-15, 2017. National Harbor, Maryland, US.
3. Ledermann J., et al. Olaparib Maintenance Therapy in Platinum-Sensitive Relapsed Ovarian Cancer. N Engl J Med 2012;366:1382-92.
4. AstraZeneca Q1 2017 Results – Lynparza: Ovarian cancer – Compelling efficacy and safety (P25). Available at: https://www.astrazeneca.com/investor-relations/results-and-presentations.html. Accessed May 2017.
5. National Institutes of Health. Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy. Available at https://clinicaltrials.gov/show/NCT01874353.%20Last%20accessed%20October%202016. Accessed May 2017.
6. GINECO. Presentation of GINECO. Association ARCAGY - GINECO - Hotel Dieu Hospital. Available at http://www.arcagy.org/arcagy-organisation-et-recherche/index.php?id=56. Accessed May 2017.
7. Cancer Research UK. Ovarian cancer incidence statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/ovary/incidence/uk-ovarian-cancer-incidence-statistics. Accessed May 2017.
8. Cancer Research UK. Ovarian cancer mortality statistics. Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats/types/ovary/mortality/. Accessed May 2017.
9. National Cancer Institute. BRCA1 and BRCA2: cancer risk and genetic testing. Available at https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet. Accessed May 2017.
10. Lynparza (olaparib) Prescribing Information. AstraZeneca Pharmaceuticals LP, Wilmington, US.
11. Lynparza (olaparib) Summary of Product Characteristics. AstraZeneca Pharmaceuticals LP, Cambridge, UK.
12. O’Connor M. ‘Targeting The DNA Damage Response In Cancer’ (2015) Mol Cell. Accessed May 2017.
13. Tutt A N J., et al. Exploiting the DNA Repair Defect in BRCA Mutant Cells in the Design of New Therapeutic Strategies for Cancer. Cold Spring Harb Symp Quant Niol. 2005;70:139-48.
14. European Network of Gynaecological Oncological Trial Groups. Mission Statement and ENGOT Activities. European Society of Gynaecological Oncology 2016. Available at https://www.esgo.org/network/engot/. Accessed May 2017.
Esra Erkal-Paler, UK/Global
+44 203 749 5638
Karen Birmingham, UK/Global
+44 203 749 5634
Rob Skelding, UK/Global
+44 203 749 5821
Jacob Lund, Sweden
+46 8 553 260 20
Michele Meixell, US
+1 302 885 2677
Thomas Kudsk Larsen
+44 203 749 5712
Craig Marks, Finance, Fixed Income, M&A
+44 7881 615 764
Henry Wheeler, Oncology
+44 203 749 5797
Mitchell Chan, Oncology
+1 240 477 3771
Lindsey Trickett, Cardiovascular & Metabolic Diseases
+1 240 543 7970
Nick Stone, Respiratory
+44 203 749 5716
Christer Gruvris, Autoimmunity, Neuroscience & Infection
+44 203 749 5711
US toll free
+1 866 381 7277
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
ResMed-sponsored Studies Show Combining Home Oxygen and Home Non-invasive Ventilation is a Cost Effective Treatment for COPD21.5.2018 00:15 | Tiedote
ResMed (NYSE: RMD, ASX: RMD) announced today the results of two clinical analyses conducted for the U.K. and U.S., demonstrating the cost effectiveness of combining home oxygen therapy and home non-invasive ventilation (NIV) therapy for patients with persistent hypercapnia following a life-threatening exacerbation of chronic obstructive pulmonary disease (COPD). The ResMed-backed Home Oxygen Therapy – Home Mechanical Ventilation (HOT-HMV) health economic studies, presented today at the ATS 2018 International Conference, build on earlier data demonstrating the clinical and cost effectiveness of HOT-HMV therapy (i.e. combining home oxygen therapy with home NIV), compared to treating with oxygen alone. The U.K. study found that HOT-HMV treatment reduced exacerbation frequency and 28-day hospital readmission. The U.S. analysis found a 58.3 percent reduction in 30-day readmissions for HOT-HMV patients compared to those on home oxygen alone – and that HOT-HMV can actually save patients money
WELL Building Standard Gaining Momentum in Europe18.5.2018 17:47 | Tiedote
As Greenbuild Europe came to a close in Berlin, the International WELL Building Institute™ (IWBI™) used the occasion to highlight how the WELL Building Standard™ (WELL™) has elevated health and well-being to the forefront of sustainability conversations across Europe. WELL continues to advance the healthy building movement as the premier standard for buildings, interior spaces and communities seeking to implement, validate and measure features that promote human health and wellness. The resonance of the program has spurred innovations across the building, design and construction industries, providing projects with customizable approaches to address geographical and cultural health concerns. To date, WELL has enrolled more than 830 projects encompassing over 155 million square feet of real estate in 32 countries worldwide. In Europe nearly 190 projects across 13 countries are engaged with WELL, representing 25% of global WELL project square footage. The strong growth of WELL over the pa
Utimaco Announces Intent to Acquire Atalla from Micro Focus18.5.2018 12:03 | Tiedote
Utimaco, the global #2 in Hardware Security Modules (HSMs), today announced the intent to acquire the Atalla HSM and ESKM business lines from Micro Focus, which were previously owned by Hewlett Packard Enterprise (HPE) prior to the September 2017 merger of its Software business with Micro Focus. Germany-based Utimaco, active in the HSM market for over 35 years, is a global manufacturer of general purpose HSMs. Utimaco has built its market leading position focusing on indirect sales through OEM or channel business partners and selling its SecurityServer product line into industries as diverse as automotive, government, media & entertainment, smart metering, semiconductors, telecommunications and the banking and financial services sectors. Utimaco is traditionally strong in its German home market based on its longstanding German banking association certification (DK) and has recently achieved PCI accreditation for the SecurityServer product line. With the acquisition of Atalla, one of th
Janssen to Present New Data in Urothelial, Haematologic and Prostate Cancers at ASCO 2018, including Best of ASCO Selections18.5.2018 10:00 | Tiedote
The Janssen Pharmaceutical Companies of Johnson & Johnson, today announced 21 company-sponsored abstracts will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on June 1-5. New data analyses in support of a portfolio of products, including the investigational treatments erdafitinib and apalutamide, as well as approved treatments Imbruvica® (ibrutinib), Darzalex® (daratumumab), and Zytiga® (abiraterone acetate) will be highlighted across urothelial, haematologic and prostate cancers. Notably, Phase 2 trial results for the investigational compound erdafitinib, which received U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation, will be presented during an oral presentation on Sunday, June 3 (Abstract #4503).1,2 For haematologic cancers, Phase 3 data from the iNNOVATE study will provide the first look at ibrutinib plus rituximab versus placebo plus rituximab in patients with newly diagnosed and relapsed/refractory Wald
Karisma Hotels & Resorts to Open Allure Palazzi Kotor Bay Hotel by Karisma in June 201818.5.2018 09:00 | Tiedote
Karisma Hotels & Resorts, an award-winning luxury hotel collection which owns and manages properties in Latin America, the Caribbean and Europe, is pleased to announce the opening of Allure Palazzi Kotor Bay Hotel by Karisma in June 2018. Built from the ground up in Montenegro’s idyllic Dobrota, the exclusive five-star beachfront property seamlessly blends stunning architecture and design with its mountainous landscape, offering spellbinding views of Kotor Bay. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180517006456/en/ Rendering of Allure Palazzi Kotor Bay (Photo: Business Wire) Sitting on Kotor Bay’s only private beach, the resort features 89 premium guestrooms, 10 villas with private beachfront access, and three breathtaking penthouse suites, each with a balcony or terrace. Allure Palazzi Kotor Bay’s accommodations encompass sumptuous bedding, divine amenities, and carefully selected color palettes bringing the sunny
Siemens Financial Services Selects GTC’s @GlobalTrade Platform for Management of Export Documentary Credits18.5.2018 07:00 | Tiedote
GlobalTrade Corporation (GTC) has announced today that Siemens Financial Services (SFS) has selected its @GlobalTrade Multi-bank Trade Finance Platform for management of its export documentary credits. The platform will be initially rolled out in Germany and thereafter expanded to Siemens entities globally. The system will electronically aggregate all incoming documentary credits in a global database, facilitate review and approval, assist in preparation of compliant documents and enable faster presentation of documents electronically to advising and issuing banks. Gerhard Heubeck, Head of Trade Finance Advisory at Siemens Financial Services, reasons the need for the new system implementation as follows: "After many years of using one of the first standard IT systems available for export documentary credits, the time has come to find a successor tool capable to meet the new requirements such as multi-client capability, processing of new SWIFT message formats, global accessibility, and
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme