The es-ORR at the primary endpoint of day 28 was 51.61% (64/124, 95% CI: 42.47% to 60.68%) in the DVDMS-PDT group and 8.06% (5/62, 95% CI: 2.67% to 17.83%) in the TPC group (P < 0.0001, Table 2). In different subgroups, the es-ORR in the DVDMS-PDT group showed benefits across all subgroups (Supplementary Figure 1A). The es-ORR at 2, 3, and 6 months post-treatment in the DVDMS-PDT group was 16.94% (21/124, 95% CI: 10.80% to 24.72%), 7.26% (9/124, 95% CI: 3.37% to 13.33%), and 1.61% (2/124, 95% CI: 0.20% to 5.70%), respectively; in the TPC group, the corresponding values were 3.23% (2/62, 95% CI: 0.39% to 11.17%), 4.84% (3/62, 95% CI: 1.01% to 13.50%), and 1.61% (1/62, 95% CI: 0.04% to 8.66%).
According to the BIRC assessment results described in Table 2, the median es-DoR in the DVDMS-PDT group was 3.61 months (95% CI: 2.46, 4.90), while the control group had too few responders for a reliable estimate. The es-TTP in the DVDMS-PDT group and the TPC group were 5.85 months (95% CI: 4.37, NE) versus 3.94 months (95% CI: 1.05, NE) (HR = 0.4486, 95% CI: 0.2462, 0.8174; log-rank P = 0.0056).