BioNTech, OncoC4 Report Positive Overall Survival Data From Phase 3 Trial of Gotistobart in Lung Cancer

05:04 AM EDT, 09/14/2026 (MT Newswires) -- BioNTech (BNTX) and OncoC4 said Monday that updated data from the first stage of their phase 3 PRESERVE-003 trial showed a statistically significant overall survival benefit for gotistobart in patients previously treated with squamous non-small cell lung cancer. The company said data showed that gotistobart nearly doubled overall survival compared with standard-of-care chemotherapy in 87 patients in the trial. Median overall survival was 18.5 months for patients treated with gotistobart compared with 10 months for those receiving standard-of-care docetaxel chemotherapy, according to the statement. Gotistobart's safety profile "remained manageable" and consistent with previously reported data, the partners added. The companies said about 44 out of every 100 patients taking gotistobart experienced a serious side effect related to the treatment, compared with about 49 out of every 100 patients taking docetaxel. BioNTech shares were up 2.9% in Monday premarket activity.