BioNTech Showcases Promising Bispecific and ADC Data in Lung Cancer at ELCC 2026

BioNTech SE will present the latest clinical updates from its late-stage lung cancer portfolio at ELCC 2026, highlighting encouraging activity for pumitamig across ES-SCLC, first-line NSCLC, and EGFR-mutant NSCLC, along with a manageable safety profile. In squamous NSCLC, gotistobart showed a 54% reduction in death risk versus chemotherapy. First clinical data for HER3-targeted ADC BNT326/YL202 also demonstrated antitumor activity and favorable tolerability.

BioNTech SE is presenting new clinical data at the European Lung Cancer Congress, held in Copenhagen from March 25 to 28, 2026, highlighting progress across its late-stage lung cancer pipeline. The company’s presentations span immunomodulators, antibody-drug conjugates, mRNA cancer immunotherapies, and combination strategies, reflecting a broad effort to develop differentiated treatments across multiple lung cancer subtypes and disease stages.

The update places particular emphasis on pumitamig and gotistobart, two late-stage immunomodulator candidates, as well as early clinical findings for the HER3-targeted ADC BNT326/YL202. Together, the data suggest BioNTech is building a diverse development program that includes both monotherapy approaches and combinations with standard treatments, alongside novel-novel regimens designed to improve therapeutic outcomes.

“The data we will present at this year’s ELCC further define the potential of our late-stage portfolio in lung cancer. With updates on pumitamig and gotistobart, as well as first clinical data for our HER3-targeted ADC, we continue to advance differentiated treatment approaches across lung cancer settings while building the clinical evidence to guide their further development,” said Prof. Özlem Türeci, M.D., Co-Founder and CMO at BioNTech. “Our aim is to offer patients with lung cancer transformative treatment options that help provide meaningful long-term benefit across all stages of the disease.”

Pumitamig, also known as BNT327/BMS986545, is a bispecific immunomodulator designed to combine PD-L1 inhibition with VEGF-A neutralization. In first-line extensive-stage small cell lung cancer, updated follow-up from a single-arm Phase 2 trial conducted in China continued to show encouraging preliminary antitumor activity and survival outcomes when pumitamig was combined with chemotherapy, with tolerability described as manageable. These findings support the ongoing global Phase 3 ROSETTA Lung-01 study.

In first-line advanced non-small cell lung cancer, data from a Phase 1b/2a study conducted in China showed preliminary antitumor activity for pumitamig monotherapy in both squamous and non-squamous disease, regardless of PD-L1 expression level. The safety profile was also reported as manageable. These results complement the ongoing global Phase 2/3 ROSETTA Lung-02 trial, which is evaluating pumitamig in combination with chemotherapy.

Another Phase 2 study in China focused on EGFR-mutant advanced or metastatic NSCLC. In that setting, pumitamig combined with chemotherapy showed clinically meaningful survival outcomes and manageable safety and tolerability, independent of PD-L1 expression. The findings suggest potential utility for patients whose disease has progressed on EGFR tyrosine kinase inhibitors.

BioNTech also reported results for gotistobart, or BNT316/ONC-392, a CTLA-4-targeting candidate designed to selectively deplete regulatory T cells in the tumor microenvironment. In stage 1 of the global Phase 3 PRESERVE-003 trial, conducted in patients with squamous NSCLC previously treated with immunotherapy plus chemotherapy, gotistobart showed clinically meaningful antitumor activity and an overall survival benefit. According to the company, the regimen was associated with a 54% reduction in the risk of death compared with standard-of-care chemotherapy, while maintaining a manageable safety profile. The pivotal stage of the trial is ongoing.

First clinical data were also presented for BNT326/YL202, a HER3-targeted ADC developed with MediLink Therapeutics. In a Phase 2 NSCLC cohort conducted in China, the candidate showed antitumor activity and a favorable safety profile in patients with advanced or metastatic disease that had progressed after standard therapy. These results support an ongoing Phase 1b/2 study evaluating BNT326/YL202 in combination with pumitamig.

BioNTech said it currently has 16 ongoing clinical trials in lung cancer, including four pivotal Phase 3 studies and five novel-novel combination trials.