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
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NOVARTIS ESMO EVENT | OCTOBER 24, 2023 | INVESTOR PRESENTATION
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