Q3 2023 Results - Reimagining Medicine
Company overview
Financial review
Conclusions
Appendix
References
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 SSE3
ORR4
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%
✓ Time to worsening (FACT-P5)
HR 0.59 (0.47, 0.72)
✓ Time to worsening (BPI-SF6)
HR 0.69 (0.56, 0.85)
Crossover-adjusted OS
HR 0.80 (0.48, 1.33)
Favorable safety
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 discontinuation7: 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)
Presented at ESMO; submission to FDA now planned in 2024
INNOVATION
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. SSE = symptomatic skeletal event. 4. 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). 5. FACT-P: prostate cancer-specific quality of life. 6. BPI-SF: severity of pain and impact of pain on daily functions. 7. Comparisons for PluvictoⓇ vs. ARPI arm.
12 Investor Relations | Q3 2023 Results
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