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Grants and Awards

Infrastructure Grants

Funds provided by Cancer Australia to support ANZUP’s infrastructure up until December 2021 were managed by the University of Sydney and not reported in the financial accounts of ANZUP unless transferred in support of specific expenses incurred by ANZUP .

In January 2022 ANZUP was successful in our 2022-2024 Support for Cancer Clinical Trials grant application and ANZUP will administer this grant . Other Grants/ Funding during the 2021-22 period are outlined below .

Infrastructure Funding

Cancer Australia Infrastructure Grant: 1 July 2018 to 30 December 2021, AUD$1,750,000 awarded to ANZUP and our collaborator, The University of Sydney . During this reporting period AUD$125,000 was transferred to ANZUP and is reported in the Annual Accounts .

ANZUP was also successful in applying for the 2022-2024 Cancer Australia Infrastructure Grant and was awarded $1,250,000 for the next 3 years . During this reporting period ANZUP received AUD$260,000 and is reported in the Annual Accounts .

Research Grants

Funds provided by Cancer Australia, the National Health and Medical Research Council, philanthropic funding bodies and pharmaceutical companies in support of ANZUP trials managed by the University of Sydney, are not reported in ANZUP’s financial accounts. Funds to support ANZUP sponsored trials and site payments, insurance and other trial related costs are transferred to ANZUP and are reflected in these accounts .

ANZUP grant income and expenditure during this reporting period are included in the 2020/2021 financial accounts. Grants awarded to ANZUP Cancer Trials Group during this reporting period are listed below:

BCGMM: Adding mitomycin to BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: a 2-stage, randomised phase 3 trial . Funding by NHMRC AUD$ $1,587,163 .80 . (2019 – 2023) . AUD$22,500 was transferred to ANZUP and reported in the annual accounts . BL.12: A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen . Funding by NCIC Clinical Trials Group AUD$1,384,662, Specialised Therapeutics AUD$250,000 (2015-2018) . During this reporting period $12,018 .72 was transferred to ANZUP .

DASL-HiCaP: A randomised phase III double-blind, placebocontrolled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in very high risk, clinically localised prostate cancer . Funding by Bayer USD$53,173,088 . During this period USD$485,455 was transferred to ANZUP and reported in the annual accounts .

ENZAMET: A randomised phase III trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer . Funding by Astellas AUD$19,962,490 (2014-2022) . During this reporting period USD$94,910 was transferred to ANZUP and was reported in the annual accounts .

ENZAMET Translational Research Program: During this reporting period US$110,000 was transferred to ANZUP for TR Execution Milestone Direct Costs and was reported in the annual accounts

ENZA-p: A randomised phase II trial using PSMA as a therapeutic agent and prognostic indicator in men with metastatic castration resistant prostate cancer treated with enzalutamide . Funding by

Prostate Cancer Research Alliance: The Australian Government and Movember Foundation Collaboration AUD$4,000,000; Endocyte USD$320,000; St Vincent’s Clinic Foundation AUD$400,000; GenesisCare AUD$300,000; and Roy Morgan Research Ltd AUD$300,000; (2020-2024) . During this reporting period AUD$1,154,037 was transferred to ANZUP and was reported in the annual accounts .

ENZARAD: A randomised phase III trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised prostate cancer . Funding by Astellas AUD$13,184,412 (2014-2022) . During this reporting period no funds were transferred to ANZUP .

Grants and Awards continued

EVOLUTION: A randomised phase II trial of Radionuclide 177Lu-PSMA Therapy versus 177Lu-PSMA in Combination with Ipilimumab and Nivolumab for Men with Metastatic Castration Resistant Prostate Cancer (mCRPC) . Funding by Prostate Cancer Foundation of Australia AUD$1,500,000; Bristol Myers Squibb USD$1,296,698, Novartis USD$320,000 (2021-2024) . During this reporting period ANZUP received AUD$1,842,874 and is reported in the annual accounts .

KEYPAD: A phase II trial using denosumab and pembrolizumab in clear cell renal carcinoma . Funding by Merck Sharpe Dohme and Amgen AUD$2,454,925 . During this reporting period ANZUP received AUD$7,000 for Translational Reasearch site payments and is reported in the annual accounts .

RAMPART: Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART) An international investigator-led phase III multiarm multi-stage multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse . During this reporting period ANZUP received AUD$670K AUD$7,000 for Translational Research site payments and is reported in the annual accounts TIGER: A Randomised Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilising Paclitaxel plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumours (ANZUP 1604) . Funding received from the Movember Foundation $454,803 .74 . No funds were received in this reporting period .

UNISoN: Phase II sequential cohort trial of Single Agent Nivolumab, then Combination Ipilimumab + Nivolumab in metastatic or unresectable non-clear cell renal cell carcinoma (ANZUP 1602) . Bristol Myers Squibb (BMS) provided funding USD$1,681,822 and product to support the UNISoN trial . During this reporting period ANZUP received no funds from BMS . We successfully applied for philanthropic grants from the Hillcrest Foundation $68,000, and the Ken & Asle Chilton Trust $4,800, as reported in the annual accounts .

UNICAB: A phase II trial of single agent cabozantinib in patients with locally advanced or metastatic non-clear cell renal cell carcinoma post immunotherapy or who are unsuitable for immunotherapy (ANZUP 1801) . During this reporting period ANZUP received AUD$275,000 and this is reported in the annual accounts .

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