Q3 2023 Results
Company overview
Innovation: Pipeline overview
Cardiovascular
Financial review
Financial performance
Immunology
Conclusions
Appendix
Innovation: Clinical trials
Neuroscience
Oncology
References
Abbreviations
PluvictoⓇ - Radioligand therapy target PSMA
PluvictoⓇ - Radioligand therapy target PSMA
NCT04689828 PSMAfore (CAAA617B12302)
NCT04720157 PSMAddition (CAAA617C12301)
Metastatic hormone sensitive prostate cancer
Indication
Metastatic castration-resistant prostate cancer, pre-taxane
Indication
Phase
Phase 3
Phase
Phase 3
Patients
450
Patients
1126
Primary
Radiographic Progression Free Survival (rPFS)
Primary
Outcome
Outcome
Measures
Measures
Arms
Arms
Intervention
Intervention
Arm 1: Participants will receive 7.4 GBq (200 mCi) +/- 10% 177 Lu-PSMA-617
once every 6 weeks for 6 cycles. Best supportive care, including ADT may be
used
Arm 2: For participants randomized to the ARDT arm, the change of ARDT
treatment will be administered per the physician's orders. Best supportive care,
including ADT may be used
mCRPC patients that were previously treated with an alternate ARDT and not
exposed to a taxane-containing regimen in the CRPC or mHSPC settings
Target
Patients
Readout
Milestone(s)
Publication
H2 2023
Primary Analysis: 2022 (actual)
Final Analysis: 2025
72 Investor Relations | Q3 2023 Results
Radiographic Progression Free Survival (rPFS)
Other
Arm 1: 177Lu-PSMA-617 Participant will receive 7.4 GBq (+/- 10%) 177 Lu-PSMA-
617, once every 6 weeks for a planned 6 cycles, in addition to the Standard of
Care (SOC); ARDT +ADT is considered as SOC and treatment will be
administered per the physician's order
Arm 2: For participants randomized to Standard of Care arm, ARDT +ADT is
considered as SOC and treatment will be administered per the physician's order
Patients with metastatic Hormone Sensitive Prostate Cancer (mHSPC)
Target
Patients
Readout
Milestone(s)
Publication
Primary Analysis: 2024
TBD
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