Nogapendekin alfa inbakicept-pmln (IL‑15 superagonist) + BCG tops pembrolizumab (PD‑1) on 12‑mo CR in BCG‑unresponsive NMIBC CIS (MAIC)

Nogapendekin alfa inbakicept-pmln (NAI; an IL‑15 superagonist cytokine complex that expands/activates NK and CD8+ T cells) plus intravesical BCG from the Phase 3 QUILT‑3.032 trial (NCT03022825) was compared vs pembrolizumab (PD‑1 inhibitor) from KEYNOTE‑057 (NCT02625961) using an unanchored MAIC/STC in BCG‑unresponsive NMIBC with CIS ± papillary disease. After weighting on 5 shared baseline variables, 12‑month CR favored NAI+BCG vs pembrolizumab (47.3% vs 18.8%; OR 3.88, 95% CI 1.77–8.50) and modeled DOR was longer by +10.65 months (26.85 vs 16.20 months); by contrast, the single‑arm KEYNOTE‑057 publication reports an initial CR of ~41% with median DOR ~16.2 months, with ~46% of responders maintaining CR ≥12 months—i.e., ~19% of the full cohort in durable CR at 12 months, broadly in the same ballpark as the MAIC’s 12‑mo CR estimate for pembrolizumab. At a 43‑month cutoff, PFS trended toward NAI+BCG (median not reached) vs pembrolizumab (39.9 months; HR 0.45, 95% CI 0.17–1.20), with no OS difference; cross‑trial TRAE comparisons were limited, but non‑bladder grade 3–4 TRAEs numerically favored NAI+BCG (OR 0.33, 95% CI 0.00–4.09).