2626 Background: LB1410 is an anti-PD-1/TIM-3 bispecific antibody (BsAb) developed by L DCR 54.5%; n = 66 as of Jan 4, 2026. Antitumor activity was especially notable in anti-PD-1-resistant ccRCC (ORR 11.1%; DCR 77.8%; n = 9) and anti-PD-1-resistant CC (ORR 38.5%; DCR 69.2%; n = 13). LB4330 is a novel, long-acting IL-10 developed by L 57.1% male; 85.7% with prior anti-PD(L)1-based therapies. TRAEs occurred in 13 pts (92.9%), the most common (≥ 20%) being fever, platelet count decreased, pruritus, elevated ALT, elevated AST, elevated creatinine, cough, rash and anemia. Most TRAEs were related to the MOA of LB4330 and were manageable. Grade 3-4 TRAEs occurred in 5 pts (35.7%), including decreased platelet count in 2 pts and IRR, shock symptom and immune-mediated myocarditis in 1 pt each. No DLTs were observed. Among all pts with on-treatment scans, the overall ORR per RECIST 1.1 was 15.4% (2/13) with 2 confirmed PR ; DCR was 30.8% (4/13). Notably, the 5 pts with anti-PD-(L)1-refractory favorable-risk ccRCC showed an ORR of 40.0% and a DCR of 80.0%. 50% ccRCC pts with PR/SD (2/4) had been on treatment for nearly one year or longer. Conclusions: The combination of LB1410 and LB4330 exhibited a manageable safety profile consistent with that observed with each monotherapy. Clinical data in pts with favorable-risk ccRCC support the characteristics and efficacy of LB4330 as an immune-enhancing agent. Efficacy expansion studies are ongoing. Clinical trial information: NCT06468358 .
Liu et al. (Wed,) studied this question.