BioNTech's Gotistobart Nearly Doubles Median Overall Survival In Previously Treated Squamous NSCLC

BioNTech (BNTX) and OncoC4 reported that gotistobart, an investigational CTLA-4-targeting monoclonal antibody, nearly doubled median overall survival to 18.5 months versus 10.0 months for docetaxel in a Phase 3 trial for metastatic squamous non-small cell lung cancer. The results, presented at the IASLC World Conference on Lung Cancer, showed a statistically significant survival benefit with a manageable safety profile, according to the companies.

BioNTech (BNTX) stock rose 5.6% in pre-market trading after presenting Phase 3 trial results showing its drug gotistobart improved survival in lung cancer patients compared to standard treatment. Morgan Stanley reiterated a Buy rating, and the company also shared early-stage data for another lung cancer treatment. The broader market was down, contrasting with BioNTech's gains.

BioNTech SE (BNTX) shares rose 6.4% premarket after announcing its drug gotistobart nearly doubled survival rates in a lung cancer trial. The drug showed a median overall survival of 18.5 months vs. 10.0 months with standard chemotherapy. The trial data was presented at the International Association for the Study of Lung Cancer 2026 World Conference. BioNTech is developing the drug jointly with OncoC4, Inc.

BioNTech (BNTX) and OncoC4 reported that their lung cancer drug, gotistobart, nearly doubled median overall survival to 18.5 months vs. 10.0 months with standard chemotherapy in a Phase 3 trial for squamous non-small cell lung cancer. The data, presented at the IASLC 2026 World Conference, showed a statistically significant survival benefit and manageable safety profile. The pivotal stage 2 of the PRESERVE-003 trial is ongoing.

BioNTech's experimental drug gotistobart showed a median survival of 18.5 months for lung cancer patients, nearly doubling the 10-month survival rate of chemotherapy. The results, from a late-stage study, could transform treatment if confirmed. BioNTech aims to bring multiple cancer drugs to market by 2030. The company is also undergoing leadership changes and recently abandoned a colorectal cancer vaccine study.

BioNTech SE (BNTX) shares dropped 1.2% to $102.55 in premarket trading after BMO Capital downgraded the stock to Market Perform and cut its price target to $105 from $128, citing lower COVID vaccine demand and inventory drawdowns. The company also terminated a Phase 2 colorectal cancer trial and reduced its 2026 revenue guidance to €1.6-1.9 billion from €2.0-2.3 billion.