BioNTech and OncoC4 Present Promising Phase 1/2 Findings for BNT316/ONC-392 Antibody Candidate in Hard-to-Treat NSCLC at ASCO
Saturday, June 03, 2023
BioNTech SE (Nasdaq: BNTX) and OncoC4, Inc. recently released positive preliminary data from their Phase 1/2 trial involving BNT316/ONC-392, an anti-CTLA-4 antibody candidate, for the treatment of metastatic, PD-(L)1-resistant non-small cell lung cancer (NSCLC). The initial results, presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, showed promising clinical anti-tumor activity of BNT316/ONC-392 as a monotherapy in a challenging patient group. The treatment also demonstrated a manageable safety profile.The trial included a cohort of 27 patients with metastatic, PD-(L)1-resistant NSCLC who had received at least two doses of 10 mg/kg of BNT316/ONC-392. At the data cutoff, the evaluable patients showed an overall response rate (ORR) of 29.6% and a disease control rate (DCR) of 70.4%. This included one complete response, seven partial responses, and eleven patients with stable disease. BNT316/ONC-392 was well-tolerated overall, with a manageable safety profile. Grade 3 and 4 immune-related adverse events (irAE) were observed in 10 patients (30%), which is relatively lower compared to similar drugs.Metastatic NSCLC carries a poor prognosis, with a 5-year survival rate of only 9%. The positive data from this trial indicate that BNT316/ONC-392 could offer a new treatment approach by targeting CTLA-4 and effectively addressing advanced and difficult-to-treat tumors. This widens the range of options available for oncologists in their quest to combat cancer. BioNTech aims to accelerate the development of this program in NSCLC, with the goal of conducting pivotal Phase 3 evaluation. This aligns with their mission of providing the most effective therapeutic strategies for each individual cancer patient.
