Abstract 1816P
Background
223Ra and enza both prolong overall survival (OS) in pts with mCRPC. Their different mechanisms of action and non-overlapping safety profiles make them attractive combination partners. Here, we present clinical outcomes of pts who received combined or layered treatment with 223Ra and enza in REASSURE (NCT02141438), a global, prospective, observational study of 223Ra use in pts with mCRPC.
Methods
Data from 1,465 pts (All pts) were analysed. Pt subgroups included “combined” (pts started 223Ra and enza within 30 days of each other, n=46) and “layered” (pts started 223Ra >30 days after starting enza or vice versa, n=205). Statistics were descriptive in nature.
Results
The proportions of pts who had completed ≥1 life-prolonging therapy for mCRPC prior to 223Ra were 43%, 52% and 61% in the combined, layered and All pts groups, respectively (30%, 27% and 33% had received prior abiraterone and 17%, 29% and 36% had received prior docetaxel, respectively). More pts in the combined group (74%) completed 6 cycles of 223Ra than in the layered (61%) or All pts (59%). Median duration of observation from start of 223Ra for combined, layered and All pts was 17.3, 11.1 and 11.5 months (mo), respectively. The proportions of pts with a ≥30% decline in alkaline phosphatase at week-12 were 58%, 41% and 47% in the combined, layered and All pts groups, respectively; corresponding values for a ≥30% decline in prostate specific antigen were 54%, 17% and 20%. Median OS was 22.2 mo (95% CI 13.7–26.8) in the combined group, 16.5 mo (95% CI 13.9–19.5) in the layered group and 15.6 mo (95% CI 14.6–16.5) in All pts. Table: 1816P
Summary of safety
Combined group n=46 | Layered group n=205 | All Pts n=1,465 | |
Drug-related any-grade TEAE, n (%) | 17 (37) | 58 (28) | 510 (35) |
Drug-related grade ≥3 TEAE, n (%) | 6 (13) | 17 (8) | 155 (11) |
Drug-related serious adverse events, n (%) | 5 (11) | 15 (7) | 80 (5) |
Concomitant bone health agent (BHA), n (%) | 25 (54) | 95 (46) | 566 (39) |
Fractures in pts with concomitant BHA, n (%) | 2 (8) | 2 (2) | 19 (3) |
Without concomitant BHA, n (%) | 21 (46) | 110 (54) | 899 (61) |
Fractures in pts without concomitant BHA, n (%) | 1 (5) | 4 (4) | 51 (6) |
Conclusions
When combined or layered with enzalutamide, treatment with 223Ra was not associated with new safety signals and did not appear to increase fracture risk. Median OS was numerically longer in the combined vs the layered group or All pts. A phase 3 trial (PEACE III, NCT02194842) investigating the combination of enza with 223Ra is ongoing.
Clinical trial identification
NCT02141438.
Editorial acknowledgement
Dr Chris Guise of Cancer Communications and Consultancy Ltd, Cheshire, UK, provided medical writing assistance (funded by Bayer). Dr Lila Adnane (Bayer) provided editorial assistance.
Legal entity responsible for the study
Bayer AG.
Funding
Bayer AG.
Disclosure
B. Tombal: Financial Interests, Personal, Advisory Board: Astellas Pharma, Bayer, Ferring, Janssen, Takeda, Steba Biotech, Sanofi, Myovant Sciences, Pfizer/Astellas; Financial Interests, Personal, Speaker’s Bureau: Amgen, Janssen, Astellas Pharma; Financial Interests, Personal, Other, Travel, accommodation, expenses: Amgen, Astellas Pharma, Bayer, Ferring, Janssen, Sanofi; Financial Interests, Personal, Expert Testimony: Tookad; Financial Interests, Personal, Other, Honoraria: Amgen, Astellas Pharma, Bayer, Ferring, Sanofi, Janssen, Pfizer, Myovant Sciences; Financial Interests, Institutional, Research Funding: Ferring. P.J. Goebell: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, Bayer, BMS, Clinsol, Eisai, EUSA, iOMedico, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Roche, Sanofi; Financial Interests, Personal, Other, Honoraria: Astellas, AstraZeneca, Bayer, BMS, Clinsol, Eisai, EUSA, iOMedico, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Apogepha; Financial Interests, Personal, Other, Travel, accommodation and expenses: Astellas, AstraZeneca, Bayer, BMS, Clinsol, Eisai, EUSA, iOMedico, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Apogepha. N.D. Shore: Financial Interests, Personal, Advisory Role: AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boston Scientific, Clarity, Clovis Oncology, Cold Genesys, Dendreon, Exact Imaging, Exact Sciences, FerGene, Foundation Medicine, Genesis Care, Invitae, Janssen, Lantheus, Eli Lilly, MDxhealth, Merck, Myovant, Myriad, Nymox, Pacific Edge, Pfizer, Phosphorous, Photocure, Propella, PreView, Sanofi Genzyme, Sema4, Speciality Networks, Sesen Bio, Telix, Tempus, Tolmar, Urogen, Vaxiion; Financial Interests, Personal, Expert Testimony: Ferring. D.J. George: Financial Interests, Personal, Other, Grants and/or fees: Acerta Pharma, the American Association for Cancer Research, Astellas, AstraZeneca, Axess Oncology, Bayer, BMS, Calithera, Capio Biosciences, EMD Serono, Exelixis, Flatiron, Ipsen, UroGPO, Janssen, Leidos Biomedical Research, Merck Sharp & Dohme, Michael J Hennessey Associates, Millennium Med Publishing, Modra Pharmaceuticals, Myovant Sciences, NCI, Nektar Therapeutics, Novartis, Pfizer, Physician Education Resource, Sanofi, UroToday, Vizuri Health Sciences. A. Pinto: Financial Interests, Personal, Advisory Role: Astellas, Janssen, Bayer, Clovis, Sanofi, Pfizer, Novartis, BMS, Roche, MSD, Pierre-Fabre, Ipsen; Financial Interests, Personal, Other, Travel grant: Pfizer, Janssen, Roche. O. Sartor: Financial Interests, Personal, Advisory Role: Bayer, Sanofi, AstraZeneca, Dendreon, Advanced Accelerator Applications, Pfizer, EMD Serono, Astellas Pharma, Progenics, Blue Earth Diagnostics, Myovant Sciences, Myriad Genetics, Novartis, Clarity Pharmaceuticals, Fusion Pharmaceuticals, Isotopen Technologien, Janssen, Clovis Oncology, Noria Therapeutics, Point Biopharma, TeneoBio, Telix Pharmaceuticals, Theragnostics, Ratio, Convergent; Financial Interests, Personal, Other, Travel expenses: Bayer, Johnson & Johnson, Sanofi, AstraZeneca, Progenics; Financial Interests, Personal, Expert Testimony: Sanofi; Financial Interests, Personal, Stocks or ownership: Lilly, GSK, AbbVie, Cardinal Health, United Health Group, PSMA Therapeutics, Clarity Pharmaceuticals, Noria Therapeutics, Clovis Oncology; Financial Interests, Institutional, Research Funding: Bayer, Sanofi, Endocyte, Merck, InVitae, Advanced Accelerator Applications, AstraZeneca, Dendreon, SOTIO, Janssen, Progenics. J. Meltzer, F. Verholen, A. Schmall: Financial Interests, Personal, Other, Employee: Bayer. F. Saad: Financial Interests, Institutional, Research Grant: Astellas, AstraZeneca, BMS, Janssen, Merck, Myovant, Novartis, Pfizer, Sanofi; Financial Interests, Personal, Advisory Role: Astellas, AstraZeneca, Janssen, Merck, Myovant, Novartis, Pfizer, Sanofi; Financial Interests, Personal, Other, Honoraria: Astellas, AstraZeneca, Janssen, Merck, Novartis, Pfizer, Sanofi; Financial Interests, Personal, Advisory Board: Astellas, Bayer, BMS, Janssen, Myovant, Novartis, Pfizer; Non-Financial Interests, Institutional, Other, Local PI nonfinancial interests: Amgen; Financial Interests, Institutional, Other, Local PI nonfinancial interests: Astellas, Bayer, BMS, Janssen, Novartis, Pfizer, Merck, AstraZeneca, Sanofi.
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