SPiReL (DPX):
Population ITT (25 patients): mOS 10'1 months.
Population "per protocol", PP (at least three doses of MvP-S received, 16 patients -64%): mOS 24,2 months.
LOTIS-2 (Loncatusimab, FDA approved in 2021):
Population "per protocol", PP (at least one dose of Lonca received, 145 out of 184 ITT -78%): mOS 10 months
So: mOS PP: 24,2 vs. 10 months (MvP-S more than double); even the ITT mOS is better than PP mOS of Lonca (10,1 vs. 10 months).
WHAT HAS HAPPENED IS A TOTAL SHAME.
[In the ITT sample, the median PFS was 4.2 months (95% CI, 3–7.1), and the median OS was 10.1 months (95% CI, 8.3–NR) (Figure 1A,B). In the PP sample, median PFS was 6.8 months (95% CI, 5.8–NR) and the median OS was 24.2 months (95% CI, 15.9–NR).]
https://onlinelibrary.wiley.com/doi/10.1111/ejh.13982
https://www.targetedonc.com/view/findings-from-the-lotis-2-trial-loncastuximab-tesirine