Q3 2022 Results
Company overview
Financial performance
Cardiovascular
Financial review
2022 priorities
Appendix
Innovation: Pipeline overview
Innovation: Clinical trials
Immunology
Neuroscience
Oncology
PluvictoⓇ - Radioligand therapy target PSMA
NCT04689828 PSMAfore (CAAA617B12302)
References
Abbreviations
Other
PluvictoⓇ - Radioligand therapy target PSMA
NCT04720157 PSMAddition (CAAA617C12301)
Metastatic hormone sensitive prostate cancer
Phase 3
1126
Radiographic Progression Free Survival (rPFS)
Indication
Metastatic castration-resistant prostate cancer, pre-taxane
Indication
Phase
Phase 3
Phase
Patients
450
Patients
Primary
Radiographic Progression Free Survival (rPFS)
Primary
Outcome
Outcome
Measures
Arms
Intervention
Target
Patients
Read-out
Milestone(s)
Arm 1: Participants will receive 7.4 GBq (200 mCi) +/- 10% 177Lu-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
Primary Analysis: 2022
Final Analysis: 2025
Publication
TBD
Measures
Arms
Intervention
Target
Patients
Arm 1: 177Lu-PSMA-617 Participant will receive 7.4 GBq (+/- 10%) 177Lu-
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)
Read-out
Milestone(s)
Publication
Primary Analysis: 2024
TBD
74 Investor Relations | Q3 2022 Results
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