ASPiRATION lung cancer study

• New 5-way partnership agreement announced between Government, industry, research and academia

• First-of-its kind study in Australia to assess the potential for a personalised healthcare approach, including comprehensive genomic profiling, to become the standard of care in cancer treatment

• Opportunity to generate high quality, real world data on the use of comprehensive genomic profiling, precision medicine and personalised healthcare

SYDNEY, 30 January 2020 – Roche Australia, in partnership with the Australian Government, today announced an agreement to jointly fund a new clinical program, called ‘ASPiRATION’, to assess the impact of personalised healthcare in lung cancer - potentially transforming the way cancer care is administered in this country.

Under the terms of the agreement, the Government and Roche will fund the costs of all study activities which will be overseen and implemented by the Australasian Lung Cancer Trials Group (ALTG), the Australian Genomic Cancer Medicine Centre (AGCMC), and the NHMRC Clinical Trials Centre (CTC). The Australian Government will commit $5 million towards the study through the Medical Research Future Fund (MRFF)1 ; while Roche will contribute $6.74 million, and access to Roche medicines via clinical trials.

Importantly, the ASPiRATION study will be the first-of-its-kind in Australia to generate high quality, real world, clinical and medical data about the impact and value of comprehensive genomic profiling (CGP), precision medicine and personalised healthcare (PHC). PHC utilises more powerful genomic diagnostic tools and precise treatments by leveraging our increasingly sophisticated understanding of differences among patients, diseases and medicines.2,3

“Comprehensive genomic profiling - when implemented at scale along with tools and processes to support personalised care plans, rapid access to innovative medicines, and systematic tracking of clinico-genomic data - enables the promise of truly personalised healthcare by identifying the right treatment for the right patient, at the right time,” said Ron Park, Vice President and Global Lead of Personalised Healthcare, Global Product Strategy, at Roche. “Roche is committed to enabling better 2/4 patient outcomes with personalised healthcare, and we’re honoured to partner with the Government and like-minded organisations in Australia.”

ASPiRATION is a national, multi-centre prospective study of the clinical impact of personalised healthcare on the management and treatment of Australians with newly diagnosed, metastatic nonsquamous non-small cell lung cancer (NSCLC) – an advanced type of lung cancer that has spread beyond the lungs into other areas of the body – while exploring the feasibility and value of implementing personalised healthcare nationwide.

By providing an end-to-end prototype of PHC in lung cancer, and utilising the unique expertise and infrastructure available to the ALTG, AGCMC and NHMRC CTC, the ASPiRATION study hopes to provide a blueprint for how PHC and CGP can be incorporated into clinical practice and become the standard of care in treating cancer in Australia.

Lung cancer is the fifth most commonly diagnosed cancer and the leading cause of cancer death in Australia.4 Compared to the other four most commonly diagnosed cancers - which have survival rates between 69 and 95 per cent - lung cancer has the lowest five-year relative survival rate at 17 per cent.5 In patients with advanced or metastatic lung cancer, survival at five years from diagnosis is just 3 per cent6 ; reinforcing the need to improve outcomes and mortality of this group, by ensuring patients are treated with the best available therapies as early as possible.

“There is a clear need for better management of advanced lung cancer to improve survival outcomes for Australian patients,” said A/Professor Nick Pavlakis, President of the ALTG. “Clinical practice is shifting toward precision medicine becoming the standard in cancer care, where treatment can be personalised to the unique genomic profile of a patient’s tumour.”

“In patients with advanced lung cancer, the identification of an actionable tumour marker unlocks potential high impact treatment options – which may have otherwise not been considered – greatly improving patients’ prognosis and long-term outcomes,” said Professor Pavlakis.

Through CGP, clinicians could find numerous different pathways for how to treat their cancer patients. Yet, access to CGP for Australian cancer patients is currently limited.

“Without national, equitable use of testing that can reliably identify the relevant genomic anomalies of tumours, many cancer patients in Australia will not receive targeted therapy at all,” said Professor David Thomas, Chief Executive Officer of the AGCMC.

“Today’s announcement of the five-way partnership provides a unique platform to translate clinical research into practice and enables the collection of real world data that can be used to inform treatment decisions and improve cancer care in Australia,” said Professor Thomas. 3/4

Roche Australia’s General Manager, Stuart Knight, acknowledged the significance of the announcement for Australia, and for Roche.

“Australia is one of the first countries globally where Roche has secured partnership agreements with governments to advance genomic profiling and personalised healthcare, following similar announcements in Croatia and Taiwan,” said Mr Knight. “Australia has world-leading expertise in genomic research and is well-positioned to become a leader in personalised healthcare. Today’s announcement supports the Federal Health Minister’s vision to make genomics and precision medicine the standard of care in Australia.” 

-Ends-

• The ASPiRATION study will aim to enrol approximately 1,000 adult patients (>18 years of age) with newly diagnosed metastatic non-squamous NSCLC.

• The study will be conducted for a 30-month period, with two years of follow up; equating to a total duration of approximately 60 months (1 Jan 2020 – 31 Dec 2024).

• It is anticipated that there will be approximately 10-15 clinical trial sites across Australia, ensuring equity of access to potential trial participants living in rural and remote areas.

• As study sponsors, the ALTG and AGCMC will consent and enrol patients at individual sites with tissue samples collected at those sites and tested as per existing processes.

• The NHMRC CTC will act as the data collection and analysis centre for both the ALTG and AGCMC sites. and will establish clinical sub studies as required.

• Partnerships with other companies offering CGP services and other pharmaceutical companies will also likely be established to enable CGP and treatments to support the study to be provided to patients free of charge.

Roche is one of the world's leading innovative pharmaceutical and diagnostic companies in oncology healthcare. These combined strengths have made the company a leader in PHC – a strategy that aims to fit the right treatment to each patient in the best way possible.

We contribute expertise and knowledge to the development and improvement of PHC to achieve better treatment outcomes. Through the use of comprehensive genomic profiling and processing of real world data to support more systematic, equitable and sustainable access of oncology patients to targeted treatments; the ability to improve quality of life for patients with malignant diseases, is within reach.

Roche is uniquely positioned to realise the transformative potential of PHC through our diagnostic and pharmaceutical expertise, leading portfolio of medicines, proven history of ground-breaking science and 4/4 deep network of strategic partnerships. Our PHC efforts have already led to significant advances in healthcare and medicine, with measurable impact on patients, physicians and regulators.

Roche is committed to delivering on this opportunity in a way that creates meaningful value for patients and healthcare systems, and the company is drawing on a unique combination of strengths to drive this transformation: a leading portfolio of medicines, expertise in medicine, biology and data-science, worldleading companies (Flatiron and Foundation Medicine), a network of partnerships and global reach.

References

1. Australian Government, Department of Health. Medical Research Future Fund. Available at:[Accessed January 2020].

2. MTPConnect. Precision Medicine Roundtable White Paper, June 2019.

3. Mathur, S & Sutton, J. Personalized medicine could transform healthcare (Review). BioMedical Reports 7:3-5;2017.

4. Australian Government, Cancer Australia. Lung cancer in Australia statistics, August 2019. Available at: https://lungcancer.canceraustralia.gov.au/statistics [Accessed January 2020].

5. Lung Foundation Australia. Making Lung Cancer A Fair Fight: A Blueprint for Reform, October 2018. 6. Australian Government, Cancer Australia. National Cancer Control Indicators: Relative survival by stage at diagnosis (lung cancer), April 2019. Available at:[Accessed January 2020]