Novartis Q4 Results

Content Click below to navigate through the document PluvictoⓇ - Radioligand therapy target PSMA PluvictoⓇ - Radioligand therapy target PSMA ↓ ↑ Company overview Financial review Conclusions NCT04689828 PSMAfore (CAAA617B12302) Metastatic castration-resistant prostate cancer, pre-taxane Indication Phase Phase 3 Patients 450 Radiographic Progression Free Survival (rPFS) NCT04720157 PSMAddition (CAAA617C12301) Metastatic hormone sensitive prostate cancer Radiographic Progression Free Survival (rPFS) Indication Phase Phase 3 Patients 1126 Primary Outcome Measures Arms Intervention Intervention Target Patients 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 Primary Analysis: 2022 (actual) Final Analysis: 2025 Readout Milestone(s) Publication H2 2023 Target Patients Readout Milestone(s) Arm 1: 177 Lu-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) Primary Analysis: 2025 Publication TBD Appendix Innovation: Pipeline overview Financial performance Innovation: Clinical trials Cardiovascular, Renal and Metabolic Immunology Neuroscience > Oncology Other Global Health Abbreviations Primary Outcome Measures Arms References □ NOVARTIS Reimagining Medicine | Novartis Q4 Results | January 31, 2024 74

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