12 minute read
Chief Executive Officer’s Report
What a year it has been! To say it has been a challenge is an understatement .
We were looking forward to a new decade and rolling out another year of innovative ANZUP programs including conducting our high quality investigator initiated clinical trials, supporting the development of a pipeline of new concepts, hosting our annual scientific meeting (ASM) as well as our Below the Belt Pedalthon fundraising events, to name a few .
Then came COVID-19, not only putting ANZUP’s plans into disarray, but the entire world . We rapidly needed to review, revise and repurpose almost everything we had planned including suspending our clinical trials as we implemented a number of strategies to ensure we met the objectives of the organisation .
Despite this curve ball, ANZUP managed to hit some significant milestones throughout the year .
Our ENZAMET clinical trial (ANZUP 1304) continued to have impact and be recognised worldwide . In 2019 the trial featured in the ASCO main plenary session, and these practice changing results continue to generate worldwide interest both through extensive media coverage and the medical community . In 2020, ENZAMET featured in ESMO’s Clinical Practice Guidelines for 2020 . ENZAMET was also named in the ASCO Annual Report on Progress Against Cancer earlier in the year as one of its Clinical Cancer Advances for 2020 . This ANZUPled trial also contributed to registration of the agent for this indication by the FDA in December 2019, and has been incorporated into US and European treatment guidelines .
On 1 December 2020, ENAZMET scooped the pool at the ACTA Trial of the Year Awards Ceremony . ENZAMET was awarded the 2020 ACTA Trial of the Year Award, the ACTA STInG Award for Excellence in Trial Statistics and the Consumer Involvement Award . A fantastic achievement and the first trial to win all three awards! We acknowledge and thank the dedicated international team of researchers, staff, consumers, and most importantly, our trial participants .
Another achievement was our TheraP trial (ANZUP 1603), featured as an oral presentation at the ASCO 2020 virtual meeting on Friday 29 May 2020, with Michael Hofman presenting the interim results . TheraP is the first randomised trial comparing 177Lu-PSMA-617 (Lu-PSMA), a novel radioactive treatment, to the current standard-of-care chemotherapy called cabazitaxel for men with metastatic castration-resistant prostate cancer . TheraP is a partnership between ANZUP and the Prostate Cancer Foundation of Australia (PCFA) with support from the Australian Nuclear Science and Technology Organisation (ANSTO), Endocyte Inc ., a Novartis Company, Movember, The Distinguished Gentleman’s Ride, It’s a Bloke Thing and CAN4CANCER and the University of Sydney’s NHMRC Clinical Trials Centre providing central study coordination . We are very grateful to all the investigators, trial coordinators, patients and their families for their participation .
Our ANZUP Clinical Trials Portfolio continues to grow across the cancers we represent . As at 31 March 2021, we had 8 ANZUP-led active and recruiting trials, 2 co-badged trials, 6 protocols in development and several translational research projects . This included DASL-HiCaP, ENZA-p and #UpFrontPSMA that all opened in 2020 during the COVID-19 pandemic .
DASL-HiCaP (ANZUP 1801) is an ANZUP-led randomised phase 3 trial adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in high risk, clinically localised prostate cancer . Study Co-Chairs are Prof Christopher Sweeney and A/Prof Tamim Niazi and the study aims to recruit 1,100 patients from close to 100 sites across Australia, New Zealand, US, Canada, UK and Ireland . In April 2020, in the midst of COVID-19, the study opened across Australia and as at 31 March was open across 24 sites in Australia and New Zealand and recruited an impressive 94 patients . We anticipate the US, Canada, UK and Ireland will open during 2021 .
ENZA-p (ANZUP 1901) is an ANZUP-led randomised phase II trial using PSMA as a therapeutic agent (Lutetium -PSMA) and prognostic indicator (PSMA-PET) in men with metastatic castrate-resistant prostate cancer treated with enzalutamide . This study is being led by Prof Louise Emmett from St Vincent’s Hospital in Sydney . The study aims to recruit 160 patients across 13 Australian sites .
Our UNICAB trial opened its first teletrial site at Goulburn Valley Hospital (Shepparton) under Border Medical Oncology (Albury) . This marks an ANZUP first and we look forward to further expanding the availability of our trials to rural and regional patients .
#UpFrontPSMA is an ANZUP co-badged randomised phase II trial of Sequential 177Lu-PSMA617 and docetaxel versus docetaxel in metastatic hormone-naïve prostate cancer . The study is being led by Prof . Arun Azad and aims to recruit 140 patients across 11 sites .
ANZUP brings together a world-class multidisciplinary team of oncology, surgical, medical, radiation, nursing, psychology and allied health professionals working in urogenital cancer . They take time out of their busy professional and personal schedules to help support ANZUP and make a difference to the lives of people affected by GU cancers .
Throughout the year ANZUP continued to encourage and support concept development within our membership – albeit in a slightly different way . Our Concept Development Workshops (CDW’s), Advanced Prostate Cancer Consensus Conference (APCCC) and our ANZUP Annual Scientific Meeting (ASM) continued to grow and bring together multidisciplinary healthcare professionals to help develop, foster and promote GU cancer research .
We held four virtual CDW’s with 115 attendees and 24 concepts presented to our multidisciplinary members . It was great to see how engaged and enthusiastic our members were in this new virtual format . These CDW’s are important as they encourage the growth and development of a pipeline of innovative ideas to be considered and prioritised with support from ANZUP over the next 12 months .
Our ASM was due to be held in Adelaide in July 2020 but sadly had to be postponed . However, we were excited to introduce our #ANZUP2020 Mini ASM, in a two-day hybrid format with local hubs and an interactive virtual meeting platform, attended by over 320 delegates . . We welcomed a superb faculty, including an impressive group of national and international speakers featuring Cristiane Bergerot, Alison Birtle, Ian Davis, Hary Dhillon, Louise Emmett, Robert Bristow, Felix Feng, Dickon Hayne, Silke Gillessen, Alicia Morgans, Tom Powles, Chris Sweeney and Bertrand Tombal Andrew Weickhardt to name a few . Popular sessions included the Nurses and Allied Health Session, MDT Master Games, ANZUP Symposium, ANZUP in Conversation, trial updates, the hotly anticipated ANZUPx sessions, as well as virtual poster discussant rooms . The outstanding faculty led discussions around the challenges and opportunities we face as we work together to improve access to clinical trials, particularly in light of the challenges of COVID-19 .
On Monday 26 October ANZUP hosted the 2nd Advanced Prostate Cancer Consensus Conference (APCCC), Asia-Pacific (APAC) Satellite Symposium - and the first time held virtually . The meeting involved 25 multidisciplinary clinicians from 14 countries: Australia, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Turkey and Vietnam . The meeting was a great success and focused on five topics discussed at APCCC viewed as most critical for the Asia-Pacific region, as well as discussion about the impact of COVID-19 . The discussions are forming a paper due for publication in the BJUI in 2021 .
Due to COVID-19 we had to cancel both our 2020 Melbourne and Sydney Pedalthon events and decided to hold our inaugural virtual Below the Belt #YourWay Challenge . During the month of September, 237 challengers and 43 teams ran, walked, cycled and swam 72,783 kms across Australia, New Zealand, UK and beyond, and raised an extraordinary $173,000 for ANZUP’s clinical trial research via the Below the Belt Research Fund . These funds will support the important work of ANZUP clinicians and researchers during isolation and into the future .
Strategic & Business Planning:
We are currently operating under the 2018-2020 Strategic Plan . The ANZUP Board, Governance, Finance & Audit, Fundraising and Partnership committees continued to meet regularly across the year (albeit via Zoom!) as well as the Scientific Advisory Committee (SAC) and SAC subcommittees, Consumer Advisory Panel (CAP) and the Trials Operations committees . These meetings help ensure our ANZUP activities are aligned with our overarching Mission and Strategic Plan .
The ANZUP Board looks forward to sharing our 2021– 2024 Strategic Plan later in 2021 .
Finances:
ANZUP continues to receive valuable infrastructure funding from the Australian Government through Cancer Australia . Whilst we value this financial and in-kind support from Cancer Australia independent funding is required for each clinical trial . It is therefore critical for ANZUP to continue to build greater financial independence and self-sufficiency through a number of fundraising avenues .
ANZUP remains committed to seeking out sustainable and innovative funding options to allow us to allow us to initiate trials and support our members in their concept and trial development in GU cancer .
ANZUP was in a strong financial position leading into 2020 and this foundation has enabled us to continue our research investment . We will remain prudent in the management of our budget and investment strategy, to ensure that we are able to continue our vital research into the future . A strong balance sheet enables ANZUP to support vital opportunities as they arise .
For further details on ANZUP’s finances, please see pages 56-77 .
Data and quality:
ANZUP works closely with the coordinating centres (NHMRC Clinical Trials Centre and the Centre for Biostatistics and Clinical Trials) to achieve robust processes on trial development and operations . Each organisation uses quality management systems, standard operating procedures (SOPs) and templates for accuracy and consistency . Data systems undergo vigorous planning, programming and checking processes prior to going live . Monitoring and formal audit processes complement these activities and annual training is provided to significant site staff ensuring data quality is maintained . All procedures and data systems comply with national and international guidelines on the conduct of clinical trials .
ANZUP also has an Independent Data and Safety Monitoring Committee (IDSMC) to evaluate the plausible benefits and risks associated with patient participation in ANZUP trials, and assess whether this justifies continuing the trials according to their original design . The IDSMC periodically reviews trial data and informs the ANZUP SAC Chair and relevant Trial Management Committee (TMC) .
Staffing:
Over the 2019/2020 reporting period, we have grown the ANZUP management team bringing a broader range of skillsets and experience to support our members and our expanding program of research activities .
I am very grateful to our dedicated team who work tirelessly to engage with and support our ANZUP members in their research endeavours . To our wonderful volunteers, Lesley Tinker and Jo Stubbs, who unfortunately due to COVID were unable to be as involved however we look forward to welcoming them back later this year .
Education and mentoring:
On an ongoing basis ANZUP seeks opportunities to expand the education and mentoring of our membership . The next generation of scientists and clinical researchers are very important to us, as they will pave the way for clinical trials to come . We host a variety of events in efforts to further their education and burgeoning clinical concepts .
Despite being virtual in 2020, our ANZUP ASM was still well-attended . It was one of the key events in Australia facilitating discussion on the latest updates in GU cancer research, treatments and supportive care with an outstanding international faculty comprised of experts in the field in attendance .
Our highly popular MDT Masterclass, part of the ASM program, is another key educational and mentoring experience for attendees . It incorporates a series of interactive care-based discussions across each of the major genitourinary cancers .
ANZUP’s Concept Development Workshops are another vital ANZUP activity aimed at educating and mentoring our membership . And despite COVID-19 we still held these virtually providing an opportunity for early-career researchers to receive mentorship whilst sharing ideas for emerging clinical trials .
Collaborations
ANZUP is proud of the national and international partnerships we have forged in our efforts to improve treatment and outcomes for patients . We are grateful to all the investigators and trial staff at the 140 hospitals across over 10 countries that we collaborate with, as well as our colleagues at the NHMRC CTC and the Centre of Biostatistics and Clinical Trials (BaCT) .
We thank our corporate supporters, sponsors and donors, for your ongoing support and generosity . With your help, ANZUP will find better treatments and outcomes for prostate cancer patients . More than ever we remain extremely grateful to our committed membership for both their ongoing support and dedication to ANZUP, even in light of both the personal and professional adversity we all faced during the year .
In July 2020 we sadly farewelled our Deputy Board Chair A/Prof Guy Toner – who retired from the Board and clinical practice . Guy was pivotal in the initial establishment of ANZUP, having for many years chaired one of its predecessor organisations, ANZGCTG . Guy has been the quiet but effective force behind many of our initiatives, including the highly successful Below the Belt Research Fund and more recently the Discretionary Funding Initiative . Guy’s wise advice and mentorship has positively influenced clinicians and researchers all over the world . We thank and acknowledge Guy for the enormous contribution he has made both to ANZUP and the global GU oncology community .
We were delighted to welcome new Director, Prof Lisa Horvath, in the reporting period . Lisa is a medical oncologist and Research Director at Chris O’Brien Lifehouse . Lisa chairs ANZUP’s Prostate Cancer Subcommittee and is a member of the SAC .
As we reflect on the year that was, and the challenges we faced both personally and professionally, I I would like to thank and acknowledge our extraordinary ANZUP Board, led by our Chair Prof Ian Davis, the SAC, Subcommittee Chairs, the CAP, Deputy Chairs, Study Chairs, Site Investigators and the hundreds of Trial Staff and members . ANZUP would not exist without you and we certainly wouldn’t have achieved what we have without your tireless efforts .
Finally, thank you to the many thousands of patients who participate in our ANZUP trials . Each and every one of you help us achieve our mission: To improve treatment and outcomes for patients and their families affected by these below the belt cancers .
Thank you .
Margaret McJannett Chief Executive Officer, ANZUP
