Business Wire

Lynparza (olaparib) Maintenance Treatment Offers Sustained Quality of Life alongside Improved Progression-Free Survival in Women with BRCA-Mutated Ovarian Cancer

2.6.2017 09:00 | Business Wire

Jaa

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

About SOLO-2

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.

About ENGOT

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

About GINECO

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.

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 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.

Intended audiences

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.

References

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.

Contact information

Media Enquiries
Esra Erkal-Paler, UK/Global
+44 203 749 5638
or
Karen Birmingham, UK/Global
+44 203 749 5634
or
Rob Skelding, UK/Global
+44 203 749 5821
or
Jacob Lund, Sweden
+46 8 553 260 20
or
Michele Meixell, US
+1 302 885 2677
Investor Relations
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
or
Mitchell Chan, Oncology
+1 240 477 3771
or
Lindsey Trickett, Cardiovascular & Metabolic Diseases
+1 240 543 7970
or
Nick Stone, Respiratory
+44 203 749 5716
or
Christer Gruvris, Autoimmunity, Neuroscience & Infection
+44 203 749 5711
or
US toll free
+1 866 381 7277

Tietoja julkaisijasta

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 tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

The Valence Group Issues Fairness Opinion to SK Capital in Connection with Archroma18.8.2017 16:30Tiedote

The Valence Group has provided a fairness opinion to SK Capital Partners, LP in connection with its recapitalization of Archroma, including investments made by various affiliates of SK Capital. Terms of the transaction were not disclosed. About SK Capital SK Capital is a private investment firm focused on the specialty materials, chemicals and pharmaceutical sectors. The firm builds strong and growing businesses that generate substantial long-term value for its investors. SK Capital utilizes its industry, operating and investment experience to identify opportunities to transform businesses into higher performing companies with improved strategic positioning, growth, profitability and risk profiles. The firm currently has approximately $1.9 billion of assets under management and its portfolio companies generate revenues of over $5.0 billion annually and employ approximat

Biker Summer 2017 campaign: What’s happening during Biker Summer 2017? Moto-tyres.co.uk is giving away exciting prizes!18.8.2017 12:22Tiedote

Whether it’s a short weekend break or a long-distance tour – once again this year Moto-tyres.co.uk is asking bikers from 10 countries about their dream destinations and longest journeys as part of its “Biker Summer 2017” campaign. To ensure than nothing gets in the way of your next tour, the two-wheeler tyre store from Delticom, Europe’s leading online tyre dealer, is entering anyone who completes the survey before 30 September 2017 into a prize draw to win some great biking accessories. Simply answer three short questions about your plans for bike tours this year (don’t forget to provide your name and email address), and with a bit of luck, you might win one of these great prizes. Up for grabs are a GARMIN motorbike GPS system, a GoPro camera with helmet bracket and five 200-Pound vouchers for new motorbike tyres from the online store – thanks to the product range at Moto-tyres.co.uk, eve

Lenovo Continues to Gain Momentum in First Quarter FY 2017/1818.8.2017 03:04Tiedote

Behind the strength of its 3-wave strategy, Lenovo’s business transformation continued to gain traction during the first quarter, delivering solid profitability in its core PC and smart devices business, and revenue and profit improvements in targeted growth areas, including the data center and mobile businesses. Fueled by new investments in people and products, Lenovo’s Data Center Group (DCG) introduced the most comprehensive product lineup in its history, with the new ThinkSystem and ThinkAgile portfolio, and continued to build out its end-to-end sales organization. Similarly, Lenovo’s Mobile Business Group launched significant new products led by the Moto Z2 Force, available now on all major U.S. carriers, and ramped up its branding efforts worldwide. “In the first quarter this fiscal year, we had stable performance as we executed our 3-wave strategy with commitment. We

Spirent Tests Wi-Fi Network Performance with O2 at the Coca-Cola London Eye17.8.2017 18:57Tiedote

Spirent Communications plc (LSE:SPT), today announced its Landslide E10 network test platform has been used with O2 to validate the Wi-Fi network performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005758/en/ Spirent Landslide E10 helped O2 validate Wi-Fi performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. (Photo: Busines Wire) Merlin Entertainments plc, operator of the London Eye, wanted to measure its Wi-Fi network performance, to ensure its infrastructure could provide an excellent experience for users of the new app, which puts increased demands on the Wi-Fi network. “The London Eye is a global attractio

Watch BizWireTV: A Camera You Can Wear and Krispy Kreme’s Famous Donuts Get Eclipsed with Chocolate17.8.2017 15:08Tiedote

On BizWireTV, catch some Quick Biz Hits and see the latest in Star Power. Also see what’s happening in the startup world with the Accelerator Report, featuring the VC Watch and this week’s Startup Standout. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005305/en/ BizWireTV is hosted by Jordyn Rolling (Photo: Business Wire Now you can watch BizWireTV, and the latest breakthroughs in tech from the biggest brands, on any screen you want by downloading the new app through the Apple TV and iPhone App Store and Google Play for Android devices. Top of the Wire Introducing FrontRow: the camera re-invented. Watch BizWireTV to see more disruptors as well as the top 5 trending stories of the week! A core c

PsiOxus Therapeutics Announce Two New Board Appointments: New Board Appointments Strengthen Company’s US Presence17.8.2017 10:00Tiedote

PsiOxus Therapeutics, Ltd. (PsiOxus) today announced the appointment of Charles Rowland and Duncan Higgons to the Board of Directors as part of an ongoing drive to expand in the US. Charles Rowland was most recently the President and Chief Executive Officer (CEO) of Aurinia Pharmaceuticals, a clinical stage pharmaceutical company focused on the global lupus nephritis market. Prior to this, he served as the Vice President and Chief Financial Officer (CFO) of ViroPharma, during which time the company grew into a global biopharmaceutical business with $500 million in annual revenues until it was acquired by Shire plc for $4.2 billion. Before joining ViroPharma, Mr. Rowland was executive Vice President, CFO, and interim co-CEO, for Endo Pharmaceuticals. In his earlier career, Charles held finance and operational positions at Biovail Pharmaceuticals, Breakaway Technologies, Pharmacia

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