The phase 1/2 PRESERVE-001 trial presented data on the ONC-392/BNT316 combination therapy for metastatic, PD-(L)1-resistant non-small cell lung cancer (NSCLC) at the 2023 ASCO Annual Meeting. The trial showed early signs of antitumor activity and manageable safety, with a 29.6% response rate among 27 evaluable patients. The expansion cohort included 25 patients, with 7 partial responses and 10 cases of stable disease, resulting in a disease control rate of 70.4%. The study authors recommended further studies using ONC-392/BNT316 monotherapy for PD-(L)1-resistant NSCLC. The FDA granted fast track designation to ONC-392 for the treatment of metastatic NSCLC. ONC-392 is a novel anti-CTLA-4 antibody that selectively depletes regulatory T cells in the tumor microenvironment. The trial is ongoing and includes a dose-finding study of ONC-392 as a single agent and in combination with pembrolizumab. Adverse effects were reported in 74% of patients, with immune-related adverse events occurring in 54%. Severe immune-related adverse events were relatively lower than other drugs of the same class. Gastrointestinal disorders and infusion-related reactions were among the reported adverse events. The clinical activity and safety profile of ONC-392/BNT316 validate its improved therapeutic index. Representative cases included a patient who showed resolution of adrenal lesions and another patient who experienced tumor shrinkage after receiving the therapy.

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