Multinational, first-in-human study of lomvastomig for advanced or metastatic solid tumors

Lomvastomig is an immunoglobulin G1-based Fc-silenced bispecific antibody that simultaneously blocks PD-1 and TIM-3. A multinational, first-in-human phase 1 study evaluated lomvastomig in patients with advanced or metastatic solid tumors. In the dose-escalation part (n=39), lovastomig was well tolerated up to the highest tested dose of 2100 mg every two weeks. One dose-limiting toxicity was reported at 1200 mg (grade 3 troponin T increase). The recommended dose for expansion was 2100 mg Q2W. In the expansion part (n=95), six patients achieved partial response. Of these, three were in the CPI-experienced melanoma cohort (n=38), which had an ORR of 8% and median PFS of 1.8 months. The other three were in the CPI-naïve esophageal squamous cell carcinoma (ESCC) cohort (n=15), resulting in an ORR of 20% and median PFS of 3.6 months. The authors conclude that lomvastomig monotherapy had a tolerable and manageable safety profile ant 2100 mg Q2W, and had promising activity in CPI-naïve ESCC.