BioNTech (BNTX) SE and OncoC4 presented data from the non-pivotal dose-confirmation stage of the global randomized Phase 3 trial PRESERVE-003 for gotistobart, a tumor microenvironment-selective regulatory T cell depletion candidate, targeting CTLA-4 in patients with metastatic squamous non-small cell lung cancer, sqNSCLC. Gotistobart demonstrated a clinically meaningful overall survival benefit compared to standard-of-care chemotherapy and a manageable safety profile in sqNSCLC patients whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. Data from the non-pivotal stage of the trial are being presented today in an oral presentation at the IASLC ASCO 2025 North America Conference on Lung Cancer, hosted by the International Association for the Study of Lung Cancer in Chicago, Illinois, USA.
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