BioNTech SE and OncoC4, Inc. have announced significant findings from their Phase 3 clinical trial for gotistobart, a novel treatment targeting metastatic squamous non-small cell lung cancer (sqNSCLC). This update, revealed on December 6, 2025, indicates that gotistobart, also known as BNT316 or ONC-392, offers a clinically meaningful overall survival benefit compared to standard chemotherapy options. The results were presented during an oral session at the IASLC ASCO 2025 North America Conference on Lung Cancer held in Chicago, Illinois.
The trial, named PRESERVE-003 (NCT05671510), is a global randomized study focusing on patients with sqNSCLC whose disease has progressed after receiving anti-PD-(L)1 therapy and platinum-based chemotherapy. The data from the non-pivotal dose-confirmation stage of the trial showcases gotistobart’s potential to enhance patient outcomes in a challenging treatment landscape.
Gotistobart works by selectively depleting regulatory T cells (Tregs) in the tumor microenvironment, primarily targeting the CTLA-4 pathway. This mechanism may help reinvigorate the immune response against tumors, making it a promising candidate for patients who have not responded adequately to existing therapies.
In the clinical trial, patients receiving gotistobart exhibited improved overall survival rates when compared to those undergoing standard-of-care chemotherapy. The results also highlighted a manageable safety profile, reinforcing the drug’s potential for broader application in this patient population.
As cancer treatment continues to evolve, these findings are crucial in addressing the needs of patients with advanced sqNSCLC. The collaboration between BioNTech and OncoC4 exemplifies the innovative approaches being pursued in oncology, focusing on enhancing patient survival and quality of life.
This announcement marks a significant milestone in the ongoing efforts to develop effective treatments for lung cancer, a disease with high mortality rates. The detailed results from the PRESERVE-003 trial are anticipated to contribute to more informed treatment strategies and possibly reshape the existing therapeutic landscape for metastatic lung cancer.
Further analysis and peer-reviewed publications will be essential to confirm these findings and assess the long-term implications for patients and healthcare providers.
