Lutetium-177 PSMA (LuPSMA) Theranostic Phase II trial: Efficacy, safety and QoL in patients

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1 Lutetium-177 PSMA (LuPSMA) Theranostic Phase II trial: Efficacy, safety and QoL in patients with castrate-resistant prostate cancer treated with LuPSMA M. S. Hofman, S. Sandhu, P. Eu, P. Jackson, T. Akhurst, A. Iravani, G. Kong, A. Ravi Kumar, S. Williams, S. Thang, D. Murphy, M. Scalzo, R.J. Hicks, J. Violet Peter MacCallum Cancer Centre, Melbourne, Australia Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia Associate Professor Michael Hofman, MBBS, FRACP, FAANMS Prostate 785O esmo.org

2 DISCLOSURE AND ACKNOWLEDGEMENTS Authors declare no conflicts of interest Lutetium-177 (no carrier added) supplied by Australian Nuclear Science & Technology Organisation (ANSTO, Australia) PSMA617 supplied by Advanced Biochemical Compounds (ABX, Germany) ANSTO and ABX provided no input into trial design, execution or analysis Supported by a Clinical Fellowship Award (MH) from the Peter MacCallum Foundation 2

3 Image from Maurer T et al. Nat Rev Urol, 2016 Apr;13(4): HOFMAN Prostate specific membrane antigen (PSMA) 68 Ga-PSMA Lu-PSMA-617 submandibular +++ liver+ kidney+++ lacrimal +++ parotid +++ spleen+ small bowel+ (duodenum++) suv Type II transmembrane glycoprotein (FOLH1) Highly over-expressed in prostate cancer castrate-resistant metastatic disease 111 In-capromab Prostascint radioactive urine PSMA PET normal biodistribution 3

4 THERANOSTICS TARGETED THERAPEUTIC + DIAGNOSTIC COMPANION 177 Lu-PSMA Ga-PSMA-11 PET/CT Post-therapy SPECT/CT Pre-therapy PET/CT 4

5 First report of 177 Lu-PSMA617 2 cycles 177 Lu-PSMA617 Cratochwil et al, Eur J Nucl Med Mol Imaging DOI /s

6 STUDY SYNOPSIS Hypothesis 177 Lu-PSMA will result in the effective delivery of therapeutic beta-irradiation to sites of malignancy with an acceptable safety profile. Observe clinically significant benefit Design 30 patient prospective, open label, single arm non-randomised pilot study Intervention Up to four cycles of 177 Lu-PSMA 4 8 GBq ± 10% adjusted according to tumor burden, renal function and body weight Australian New Zealand Clinical Trials Registry, ACTRN

7 ENDPOINTS Primary Toxicity (CTCAE 4) Activity PSA response (PCWG2) Quality of life (EORTC QLQ-C30, BPI-SF) Imaging response (RECIST, bone scan, PSMA/FDG PET) Secondary Dosimetry to tumors and normal tissue Progression free and overall survival Study data collected using REDCap hosted at the University of Melbourne. Statistical analysis: R-Statistics with ggplot2 7

8 PATIENT ELIGIBILITY Inclusion Castration-resistant Documented progression after Docetaxel Enzalutamide or abiraterone ECOG 2 High uptake on PSMA PET unless contraindicated or patient refused Exclusion GFR < 40 ml/min Platelet < 75,000 Neutrophil < 1.5 Hb < 9.0 Albumin < 25 FDG PET/CT demonstrating discordant disease 8

9 SCREENING FAILURE HOFMAN 1. LOW PSMA EXPRESSION SUV DISCORDANT FDG+ PSMA- PSMA FDG + PSMA PET PSMA PET FDG PET 9 9

10 PATIENT FLOW CHART Interim analysis 1 May pt awaiting a final treatment cycle. 43 pt assessed for eligibility 30 pt enrolled 177 Lu-PSMA + SPECT/CT Up to 4 cycles, 6 weekly 3 months follow-up Restaging CT Bone scan FDG PET PSMA PET 51 Cr-EDTA GFR 10/ /2016 QoL: EORTC QLC-30 / BM22, BPI-SF Prior to each cycle : bloods (PSA, FBE / UE / LFTs), clinical Ax Repeated +2 and +4 weeks CT Bone scan FDG PET PSMA PET 51 Cr-EDTA GFR 13 patients not eligible Imaging (7): low PSMA (2), FDG discordance (2) or both (3) Hb<90 (3), ECOG>2 (2), no progression (1) 14 patients received <4 cycles 27% progression 17% exceptional response (no or minimal uptake on SPECT) 3% cytopenia Lu-177 PSMA617 administrated via slow intravenous infusion. Oral hydration encouraged. No pre-medication. Day admission. 10

11 PATIENT CHARACTERISTICS Characteristic Mean SD (Range) Prior treatments Age (50 86) Years since diagnosis 9 (2 17) PSA (ng/ml) ( ) PSA doubling time (mnths) ( ) Palliative RT Cabazitaxel Docetaxel Enza or Abi Any chemo 47% 47% 80% 83% 87% ALP (52 542) Haemoglobin (92 161) ECOG 0: 37% 1: 47% 2: 17% Prior chemo regimens 0: 13% 1: 40% 2: 47% Visceral Nodal Bone Sites of disease on PSMA PET/CT 10% 80% 97% 11

12 1º ENDPOINT: PSA RESPONSE PSA 12 Weeks from 1 st dose Best PSA Response (PCWG2 criteria) >50% in 50% >50% in 57% >80% in 27% >80% in 43% 12

13 TOXICITY Non haematological attributable to LuPSMA: Toxicity G1/2 (%) G3/4 (%) Dry mouth 63 0 Nausea* 50 0 Vomiting* 20 0 Fatigue 17 3 Dry eyes 7 0 Bone pain 7 3 Anorexia 7 0 Infusion related reactions 0 0 Renal toxicity 0 0 Haematoxicity: Toxicity G1/2 (%) G1/2 (%) G3/4 (%) G3/4 (%) (baseline) (any cause) (LuPSMA) Haemoglobin Neutrophils** Platelets * transient and self-limiting within first 24 hours ** no episodes of febrile neutropenia CTCAE version 4: adverse events that occurred within 12 weeks after last injection of LuPSMA, or more than 12 weeks if determined to be related to LuPSMA 13

14 Dosimetry from 1 st cycle HOFMAN >50 Dose in Gy (tumour and normal tissues) Adrenal mets: 68 Gy Bone mets: 33 Gy Parotid: 4 Gy Kidney: 3 Gy Voxel-based Monte-Carlo dosimetry from 4, 24 & 96hr qspect/ct (8GBq 177 Lu-PSMA617) 14

15 PSA PROGRESSION FREE SURVIVAL (PCGW2 criteria) Median 6.3 months (95% CI ) OVERALL SURVIVAL Median 12.7 months (95% CI 9.9 not reached) Median 6.2 months Kaplan-Meier Plot with 95% confidence interval 15

16 QUALITY OF LIFE BASELINE 2 ND CYCLE Unchanged; 16; 53% Better; 11; 37% Unchanged; 10; 48% Better; 9; 43% Worse; 3; 10% EORTC Global Health Score n=30 EORTC QLQ-C30 / BPI-SF better: +10 points worse: -10 points or not completed owing to progression/death Worse; 2; 9% BPI Mean Severity Score n=21 with pain 16

17 PSA Follow-Up Case: Intermittent Further Rx PSA on trial Days from 1 st dose LuPSMA 17

18 STRENGTHS Important need First prospective data of LuPSMA Theranostics: see what you treat Encouraging activity: PSA>50% in 57% Highly targeted: limited toxicity LIMITATIONS Single-centre study >10 years experience in 177 Lu therapy (DOTATATE in NET) radiopharmacy expertise Longer follow-up to identify any delayed toxicities No comparator arm: limits interpretation of PFS / OS and toxicity data 18

19 CONCLUSIONS In men with mcrpc who have progressed after standard therapies with PSMA-avid disease, LuPSMA has high response rates, limited toxicity with improvements in pain and well-being. Warrants further evaluation: TheraP Trial : 200 pt multi-centre phase II RCT vs cabazitaxel (ANZUP / PCFA / ABX / ANSTO) LuPSMA + anti-pd1 Ab pilot study (Victorian Cancer Agency) LuPSMA + PARPi phase I study (PCF Challenge Award) 19

20 Uro-oncology team Nuclear Medicine team esmo.org Peter MacCallum Cancer Centre, Melbourne, Australia

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