Novartis ESMO Event Presentation slide image

Novartis ESMO Event Presentation

PSMAfore study showed robust efficacy with favorable safety of Pluvicto in PSMA+ mCRPC patients in the pre-taxane setting Robust efficacy rPFS1 Median rPFS2 PSA50 response Time to SSE ORRĀ³ Pluvicto vs. ARPI arm HR 0.41 (0.29, 0.56) 12.0 vs. 5.6 months 57.6% vs. 20.4% HR 0.35 (0.22, 0.57) 50.7% vs. 14.9% HR 0.59 (0.47, 0.72) HR 0.69 (0.56, 0.85) Time to worsening (FACT-P4) Time to worsening (BPI-SF5) Crossover-adjusted OS HR 0.80 (0.48, 1.33) Favorable safety profile Vast majority of AEs low-grade Grade 3-4 AES: 33.9% Pluvicto vs. 43.1% ARPI SAES: 20.3% Pluvicto vs. 28.0% ARPI AEs leading to discontinuation6: 5.7% vs. 5.2% AEs leading to dose adjustment: 3.5% vs. 15.1% Overall exposure to Pluvicto ~2,000 patient-years (incl. VISION, PSMAfore and post-marketing experience) Unadjusted OS (84% crossover) HR 1.16 (0.83, 1.64) 1. Primary rPFS analysis based on 166 rPFS events per BICR assessment (or centrally confirmed rPFS events); 1-sided p-value: <0.0001. Updated analysis of rPFS (at time of 2nd interim OS analysis) was consistent, with HR 0.43 (0.33, 0.54). All other data points from updated analysis with more mature data. 2. (95% CI): 12.0 (9.3, 14.4) vs. 5.6 (4.2, 5.95) 3. ORR in soft tissue per RECIST 1.1 for pts with measurable disease at baseline; (95% CI): 50.7% (38.6, 62.8) vs. 14.9% (7.7, 25.0) 4. FACT-P: prostate cancer-specific quality of life 5. BPI-SF: severity of pain and impact of pain on daily functions 6. Comparisons for Pluvicto vs. ARPI arm 27 NOVARTIS ESMO EVENT | OCTOBER 24, 2023 | INVESTOR PRESENTATION NOVARTIS | Reimagining Medicine
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