Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster session 10

1611P - Haematologic impact of [177Lu]Lu-PSMA-617 versus ARPI change in patients with metastatic castration-resistant prostate cancer in PSMAfore

Date

14 Sep 2024

Session

Poster session 10

Topics

Clinical Research;  Therapy

Tumour Site

Prostate Cancer

Presenters

Kim Nguyen Chi

Citation

Annals of Oncology (2024) 35 (suppl_2): S962-S1003. 10.1016/annonc/annonc1607

Authors

O. Sartor1, K. Fizazi2, J.S. de Bono3, N.D. Shore4, K. Herrmann5, D.E. Castellano Gauna6, J.M. Piulats Rodriguez7, A. Flechon8, X.X. Wei9, H. Kim10, M. Schweizer11, S. Alanee12, S. Ghebremariam13, M. Hertelendi14, M.J. Morris15

Author affiliations

  • 1 Hematology/oncology Department, Mayo Clinic - Rochester, 55905 - Rochester/US
  • 2 Cancer Medicine Department, Institut Gustave Roussy, 94805 - Villejuif, Cedex/FR
  • 3 Division Of Clinical Studies, Royal Marsden Hospital Institute of Cancer Research, SM2 5NG - Sutton/GB
  • 4 Uro-oncology Department, Atlantic Urology Clinics, LLC, 29572 - Myrtle Beach/US
  • 5 Nuclear Medicine Department, University Hospital Essen, 45147 - Essen/DE
  • 6 Medical Oncology Department, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 7 Dept. Medical Oncology, ICO - Institut Català d'Oncologia l'Hospitalet (Hospital Duran i Reynals), 08908 - Barcelona/ES
  • 8 Oncology, Centre Leon Berard, 69008 - Lyon/FR
  • 9 Oncology, Dana Farber Cancer Institute, 02215 - Boston/US
  • 10 Department Of Radiation Oncology, Washington University in St. Louis, 63108 - St. Louis/US
  • 11 Internal Medicine, Division Of Medical Oncology, University of Washington, WA 98109 - Seattle/US
  • 12 Oncology, Novartis Pharmaceuticals, 27560 - Morrisville/US
  • 13 Oncology, Novartis Pharmaceuticals Corporation, 07936 - East Hanover/US
  • 14 Medical Affairs, Novartis Pharmaceuticals Corporation, 4002 - Basel/CH
  • 15 Medicine Dept, MSKCC - Memorial Sloan Kettering Cancer Center, 10065 - New York/US

Resources

Login to get immediate access to this content.

If you do not have an ESMO account, please create one for free.

Abstract 1611P

Background

In PSMAfore (NCT04689828), [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolonged rPFS versus androgen receptor pathway inhibitor (ARPI) change with a favourable safety profile in taxane-naive patients with metastatic castration-resistant prostate cancer (mCRPC). We report the incidence, risk factors and management of haematologic treatment emergent adverse events (TEAEs).

Methods

Adults with PSMA-positive mCRPC and one progression on prior ARPI were randomized 1:1 to 177Lu-PSMA-617 (7.4 GBq Q6W; 6 cycles) or ARPI change. The primary endpoint was rPFS; secondary endpoints included frequency of TEAEs and safety laboratory assessments. Haematologic TEAEs (CTCAE v5.0 coding) were grouped by MedDRA v26.1 terms. Baseline metastatic bone disease was assessed by bone scan. Baseline, on-treatment and follow-up haematology were assessed. The safety analysis set and 27 February 2024 data cutoff (third interim OS analysis) were used.

Results

Incidences of haematologic TEAEs were higher among patients receiving 177Lu-PSMA-617 than ARPI change (Table). For 177Lu-PSMA-617 versus ARPI change, haematologic TEAE incidences were 33/109 (30.3%) versus 22/113 (19.5%) in patients with ≤5 metastatic bone lesions and 53/118 (44.9%) versus 32/119 (26.9%) in patients with >5 bone lesions; incidence did not increase for patients receiving 5/6 versus 1–4 doses of 177Lu-PSMA-617. For 177Lu-PSMA-617 versus ARPI change: 29 patients (12.8%) versus 28 (12.1%) received blood transfusions (on-treatment: 19 [8.4%] vs 26 [11.2%]); 4 (1.8%) versus 3 (1.3%) received erythropoietin; 3 (1.3%) versus 0 received granulocyte colony stimulating factors.

Conclusions

Despite higher incidences of haematologic TEAEs among patients receiving 177Lu-PSMA-617 compared with ARPI change, rates of complications or need for management of haematologic TEAEs were low and similar between treatment arms. Table: 1611P

177Lu-PSMA-617n=227 ARPI changen=232
All grades Gr ≥3 All grades Gr ≥3
Pts with ≥1 event, n (%) a 86 (37.9) 30 (13.2) 54 (23.3) 20 (8.6)
Anaemia & haemoglobin decreased 63 (27.8) 14 (6.2) 45 (19.4) 16 (6.9)
Thrombocytopenia & platelet count decreased 23 (10.1) 7 (3.1) 9 (3.9) 2 (0.9)
Neutropenia & neutrophil count decreased & febrile neutropenia 18 (7.9)b 5 (2.2)b 5 (2.2)c 2 (0.9)c
Lymphopenia & lymphocyte count decreased 15 (6.6) 10 (4.4) 3 (1.3) 1 (0.4)
Leukopenia & white blood cell count decreased 14 (6.2) 3 (1.3) 3 (1.3) 1 (0.4)
Pancytopenia 1 (0.4) 0 1 (0.4) 0

DCO 27 Feb 2024aRelated TEAEs as reported in the CRF are combined; patients are counted once per preferred term Febrile neutropenia: bn=2; cn=0

Clinical trial identification

NCT04689828, Protocol release date: 21 Feb 2023.

Editorial acknowledgement

Under direction of the authors, Katie Willetts, PhD, of Oxford PharmaGenesis, Oxford, UK provided medical writing support, which was funded by Novartis.

Legal entity responsible for the study

Novartis.

Funding

Novartis.

Disclosure

K.N. Chi: Financial Interests, Personal, Invited Speaker: Astellas, AstraZeneca, Janssen, Point Biopharma, Roche; Financial Interests, Personal, Advisory Board: AstraZeneca, AstraZeneca, Janssen, Merck, Novartis, Pfizer, Point Biopharma, Roche, BMS; Financial Interests, Institutional, Steering Committee Member: AstraZeneca, Janssen, Novartis, Roche; Financial Interests, Institutional, Trial Chair: AstraZeneca, Arvinas, Janssen, Novartis; Financial Interests, Institutional, Local PI: Arvinas. O. Sartor: Financial Interests, Personal, Writing Engagement: Novartis; Financial Interests, Institutional, Research Grant: AAA, Amgen, AstraZeneca, Bayer, Endocyte, Invitae, Janssen, Lantheus, Merck, Progenics, and Tenebio; Financial Interests, Personal, Speaker, Consultant, Advisor: ARTBIO, AAA, AstraZeneca, Bayer, Blue Earth Diagnostics, Clarity Pharmaceuticals, Fusion, Isotopen Technologien Muenchen, Merck, Janssen, Myovant, Myriad, Noria Therapeutics, Novartis, NorthStar, POINT Biopharma, Pfizer, Sanofi, Tenebio, and Telix; Financial Interests, Personal, Other: Lantheus, Novartis, and NorthStar;; Financial Interests, Personal, Advisory Board: AstraZeneca, Merck, and Pfizer; Financial Interests, Personal, Stocks or ownership: Artbio, Ratio, Clarity, Convergent, Fusion, Lilly, Pfizer, Telix. K. Fizazi: Financial Interests, Institutional, Advisory Board: Astellas, Bayer, Janssen, AAA, MSD, AstraZeneca, Novartis/AAA, Pfizer, Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: Astellas, Bayer, Janssen, Sanofi, MSD, AstraZeneca, Novartis, Pfizer; Financial Interests, Personal, Advisory Board: Curevac, Orion; Financial Interests, Personal, Advisory Board, February 2022: Arvinas; Financial Interests, Personal, Advisory Board, April 2022: Macrogenics; Financial Interests, Institutional, Research Grant, Trial chair: Pfizer, Bayer, AstraZeneca, Orion, MSD, BMS, Janssen; Non-Financial Interests, Principal Investigator, Chair of the 7DX phase 3 trial: BMS; Non-Financial Interests, Principal Investigator, Chair of the Docetaxel-pembrolizumab phase 3 trial: Merck; Non-Financial Interests, Principal Investigator, Chair of the Darolutamide BCR phase 3 trial: Bayer; Non-Financial Interests, Principal Investigator, Chair of the PSMAfore phase 3 trial: AAA/Novartis; Non-Financial Interests, Principal Investigator, Chair of the CYPIDES ODM-208 Phase I-II trial: Orion; Non-Financial Interests, Principal Investigator, Chair of the STESIDES ODM-209 Phase I-II trial: Orion; Non-Financial Interests, Principal Investigator, Chair of the CAPITELLO 281 phase 3 trial: AstraZeneca; Non-Financial Interests, Principal Investigator, Chair of the TALAPRO-2 and TALAPRO-3 phase 3 trials: Pfizer; Non-Financial Interests, Principal Investigator, Chair of the RADIANT phase 3 trial: Bayer; Non-Financial Interests, Principal Investigator, Chair of the TRITON-3 phase 3 trial: Clovis. J.S. de Bono: Financial Interests, Personal, Advisory Board: Amgen, Astellas, AstraZeneca, Bayer, Bioxcel Therapeutics, Boehringer Ingelheim, Cellcentric, Daiichi Sankyo, Eisai, Genentech Roche, Genmab, GSK, Janssen, Merck Serono, Merck Sharp & Dohme, Orion Pharma, Pfizer, Qiagen, Sanofi Aventis, Sierra Oncology, Taiho, Terumo, Vertex Pharmaceuticals, Menarini Silicon Biosystems, ImCheck Therapeutics, Crescendo, MetaCurUm, Myricx, Nurix Therapeutics, Oncternal Therapeutics; Financial Interests, Institutional, Advisory Board: Harpoon, Dark Blue Therapeutics, Novartis, Takeda, Tango Therapeutics; Financial Interests, Institutional, Research Grant: Astellas, AstraZeneca, Bayer, Cellcentric, Daiichi Sankyo, Genentech Roche, Genmab, GSK, Harpoon, Janssen, Merck Serono, Merck Sharp & Dohme, Orion Pharma, Pfizer, Sanofi Aventis, Sierra Oncology, Taiho, Vertex Pharmaceuticals, Crescendo Biologics, Menarini Silicon Biosystems, Immunic Therapeutics, MetaCurUm, Myricx, Nurix Therapeutics, Oncternal Therapeutics; Financial Interests, Institutional, Local PI: Amgen; Non-Financial Interests, Principal Investigator: Amgen, Astellas, AstraZeneca, Bayer, Bioxcel Therapeutics, Boehringer Ingelheim, Cellcentric, Daiichi Sankyo, Eisai, Genentech Roche, Genmab, GSK, Harpoon, Janssen, Menarini Silicon Biosystems, Merck Serono, Merck Sharp & Dohme, Orion Pharma, Pfizer, Qiagen, Sanofi Aventis, Sierra Oncology, Taiho, Terumo, Vertex Pharmaceuticals, Crescendo, ImCheck Therapeutics, Immunic Therapeutics; Non-Financial Interests, Institutional, Product Samples: Daiichi Sankyo, Bayer, Merck Serono, AstraZeneca, Harpoon, Pfizer, Sierra Oncology, Genentech/Roche, Sanofi Aventis, GSK. N.D. Shore: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Boston Scientific, Cold Genesys, Dendreon, Exact Imaging, Genesis Care Us, Invitae, Janssen, MDxhealth, Merck, Myovant, Myriad, Nymox, Pacific Edge, Pfizer, Propella, Sanofi Genzyme, Speciality Networks, Tolmar, Urogen, Clarity, Lantheus, Lilly, Photocure, Telix, Photocure, Asieris, Alessa Therapeutics, Arquer, Fize medical, GConcology, Guardant, Ferring, Foundation Medicine, Immunitybio, Incyte, Minomic, NGM, Nonagen, Novartis, PlatformQ, Promaxo, Protara, Accord, Antev, Aura biosciences, Sumitomo; Financial Interests, Personal, Member of Board of Directors: Photocure, Alessa Theraputics; Financial Interests, Personal and Institutional, Local PI: AstraZeneca, Bayer, Aura, Exact Imaging, Janssen, Merck, Myovant, Novartis, Pfizer, Propella, Bristol Myers Squibb, Dendreon, Pfizer, Urogen; Financial Interests, Institutional, Local PI: Alessa, GC Oncology, FORMA therapeutics, Pacific edge, Point Biopharma, The MT group, Theralase, Verity, Astellas, Palette Life Sciences, Steba, Zenflow. K. Herrmann: Financial Interests, Personal, Advisory Board: Bayer, Adacap/Novartis, Curium, Boston Scientific, GE Healthcare, AstraZeneca; Financial Interests, Personal, Invited Speaker: Sirtex, Siemens Healthineers, Monrol; Financial Interests, Personal, Other, Consultant: Amgen; Financial Interests, Personal, Other, DMSB: Y-mAbs; Financial Interests, Personal, Advisory Board, Scientific Advisor: AdvanceCell; Financial Interests, Personal, Advisory Board, Advisor, Consultant: Janssen; Financial Interests, Personal, Advisory Board, Consultant: Eco1R, Fusion Pharmaceuticals, Genentech; Financial Interests, Personal, Member of Board of Directors: Sofie Biosciences, Pharma 15; Financial Interests, Personal, Ownership Interest: Sofie Biosciences; Financial Interests, Personal, Stocks/Shares: Aktis Oncology, AdvanCell, Convergent Therapeutics; Non-Financial Interests, Leadership Role, Chair Oncology&Theragnostics Committee: EANM. D.E. Castellano Gauna: Financial Interests, Personal, Advisory Board: Pfizer, ROCHE, BMS, JANSSEN, ASTELLAS, MSD, IPSEN, AstraZeneca, NOVARTIS, GSK; Financial Interests, Institutional, Local PI: PFIZER, ROCHE, MSD, BMS, AstraZeneca, JANSSEN, ASTELLAS, IPSEN, EXELISIS, EISAI, LILLY, BAYER, GSK, CLOVIS, QED Therapeutics; Non-Financial Interests, Other, any: Associate Professor of Medical Oncology/Internal Medicine department; Non-Financial Interests, Personal, Other, Executive member: SOGUG (Spanish Oncology Genito-Urinary Group) Foundation; Non-Financial Interests, Personal, Training, Head of GU Alliance for Research and Development Consortium: GUARD Consortium; Other, any: Member of the Internal/local Pharmacy Commission at the Hospital Universitario 12 de Octubre. J.M. Piulats Rodriguez: Financial Interests, Personal, Advisory Board: Janssen, Astellas, Roche, BMS, MSD, BeiGene, VCN, AstraZeneca, Immunocore, Novartis; Financial Interests, Personal and Institutional, Research Grant: BMS, Pfizer, Janssen, BeiGene, Mirati, Immunocore, Regeneron. A. Flechon: Financial Interests, Personal, Ownership Interest: Janssen, Novartis, Adacap, Bayer, Astellas, Pfizer, AstraZeneca. X.X. Wei: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Other, Membership on Biomarker/Immune Response Monitoring Committee (BIRMC): Dendreon; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Institutional, Coordinating PI: Bristol Myers Squibb; Non-Financial Interests, Advisory Role: MacroGenics, MacroGenics; Non-Financial Interests, Principal Investigator: Barinthus Biotherapeutics, MacroGenics, Novartis, Poseida. H. Kim: Financial Interests, Personal, Speaker, Consultant, Advisor: Novartis; Financial Interests, Personal and Institutional, Speaker, Consultant, Advisor, Research, Speaker fees and travel: Varian; Financial Interests, Personal, Ownership Interest: GlobalART. M. Schweizer: Financial Interests, Personal, Advisory Board: Sanofi, AstraZeneca; Financial Interests, Personal, Other, Consultant: PharmaIn; Financial Interests, Institutional, Local PI: Zenith Epigenetics, BMS, Merck, Janssen, Pfizer, F. Hoffmann-La Roche, Tmunity, Epigenetix, Incyte, Ambrx Inc.; Financial Interests, Institutional, Coordinating PI: AstraZeneca, Signal One. S. Alanee: Financial Interests, Personal, Full or part-time Employment: Novartis Oncology. S. Ghebremariam: Financial Interests, Personal, Full or part-time Employment: Novartis Oncology. M. Hertelendi: Financial Interests, Personal, Full or part-time Employment: Novartis Oncology. M.J. Morris: Financial Interests, Personal, Advisory Board: Oric, Pfizer, Exelixis, Lantheus, AstraZeneca, Amgen, Daiichi Sankyo, Convergent, Clarity Pharmaceuticals, Blue Earth Diagnostics, POINT Biopharma, Telix, Z-alpha; Financial Interests, Personal, Invited Speaker: Progenics, ITM Isotope Technologies; Financial Interests, Personal, Stocks/Shares: Doximity; Financial Interests, Institutional, Coordinating PI: Novartis, Celgen; Financial Interests, Institutional, Local PI: Corcept, Janssen, Astellas; Non-Financial Interests, Advisory Role: Bayer, Janssen Oncology, Novartis; Other, Travel to conference: AstraZeneca; Other, Travel/lodging at conference: APCCC.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.