Jul. 2 at 2:01 PM
$AGEN As of 13 December 2025, 123 pts received BOT+BAL (median FU, 16.4 mo [range, 0.7–62.3]; median FU via reverse Kaplan-Meier, 34.8 mo [95% CI, 28.2–37.8]). Median prior lines was 3 (range, 1–10; 67% had ≥3 prior lines) and 15% had prior anti–PD-(L)1±CTLA-4. Most common tx-related adverse events were diarrhea (39%; grade ≥3, 8%) and fatigue (37%; grade ≥3, 2%). Confirmed ORR was 21% (95% CI, 14–29; 2 additional responders since prior report), median DOR was not reached (NR; 95% CI, 7.3 mo–NR), median PFS was 4.0 mo (95% CI, 2.8–4.1; 18-mo PFS, 18% [95% CI, 11–26]), median OS was 21.2 mo (95% CI, 16.2–23.8), and 36-mo OS was 33% (95% CI, 24–43). Efficacy was consistent in pts exposed to late-line tx (n=37, 30%; ORR, 22% [95% CI, 10–38]; median OS, 16.2 mo [95% CI, 9.7–31.3]; 36-mo OS, 30% [95% CI, 15–46]).
