Q4 2021 Results
Participants
Company overview
Pharmaceuticals
Oncology
Financial review
Conclusion
Appendix
Preparing for 177 Lu-PSMA-617 launch in the US, expected H1 2022
Potential new treatment paradigm in mCRPC,
based on strong Ph3 VISION data
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Significant unmet need in mCRPC1
177Lu-PSMA-617 + SOC reduced risk of death by 38%,
rPFS or death by 60%, compared to SOC alone²
Median OS 15.3 months (rPFS 8.7 months), vs. 11.3 months
(rPFS 3.4 months) for SOC alone²
29.8% overall response compared to 1.7% with SOC alone²
Safety profile in line with prior experience²
Administration advantages (6 one-time infusions)
over chronic therapies²
Laying the foundation for a steady launch,
FDA action expected H1 2022, EMA H2 2022
✓ Hospital capacity sufficient for launch in VISION population
Targeting >225 treatment sites in US, ~200 sites in EU
(all LutatheraⓇ treatment sites)
PET imaging available; 68Ga-PSMA-11 imaging agent
included in NCCN guidelines
Leveraging LutatheraⓇ team and experience; incremental FF
fully recruited in US, on track in EU
Extensive disease state education underway
Two ongoing Ph3 studies in mCRPC pre-taxane (PSMAfore) & MHSPC (PSMAddition),
potential to expand eligible patient population for 177 Lu-PSMA-617 by 3-4x
1. VISION population: PSMA+ post ARPI and Taxane; approx. 10 months median OS on available treatments in late line mCRPC; 30% five-year survival prognosis; 80%+ of patients PSMA positive.
10.1056/NEJMoa2107322.
2. Sartor, et al. NEJM 2021; doi:
37 Investor Relations | Q4 2021 Results
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