Q3 2021 Investor Relations Results
Participants
Company overview
Pharmaceuticals
Financial performance
Oncology
Financial review
Conclusion
Appendix
References
Innovation: Pipeline overview
Innovation: Clinical trials
CRM
IHD
Neuroscience
Ophthalmology
Respiratory & Allergy
Oncology: Solid Tumors
Hematology
Biosimilars
Global Health
Abbreviations
177Lu-PSMA-617 - Radioligand therapy target PSMA
Study
Indication
Phase
Patients
Primary Outcome
Measures
Arms Intervention
Target Patients
Read-out Milesstone(s)
NCT04689828 PSMAfore (CAAA617B12302)
Metastatic castration-resistant prostate cancer, pre-taxane
Phase 3
450
Radiographic Progression Free Survival (rPFS)
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
NCT04720157 PSMAddition (CAAA617C12301)
Metastatic hormone sensitive prostate cancer
Phase 3
1126
Radiographic Progression Free Survival (rPFS)
Arm 1: 177Lu-PSMA-617 Participant will receive 7.4 GBq (+/- 10%) 177Lu-PSMA-
617, once every 6 weeks (+/- 1 week) 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)
Primary Analysis: 2024
Publication
TBD
110 Investor Relations | Q3 2021 Results
TBD
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