BioNTech presents new ELCC 2026 data underscoring the strength and differentiation of its late-stage lung cancer pipeline
BioNTech has announced that it will showcase new clinical data from its expanding lung cancer pipeline at the European Lung Cancer Congress 2026, taking place in Copenhagen, Denmark, from March 25 to 28, 2026. The presentations, which include both oral sessions and poster discussions, will highlight the company’s progress across multiple investigational therapies, including advanced-stage immunomodulators and antibody-drug conjugate (ADC) programs. These updates reflect BioNTech’s continued commitment to addressing the diverse and complex needs of patients with lung cancer across different subtypes and stages of disease.
The data to be presented span BioNTech’s late-stage pipeline, with a particular focus on two key immunotherapy candidates—pumitamig and gotistobart—as well as emerging ADC approaches such as BNT326/YL202. Collectively, these programs illustrate the company’s strategy of combining innovative mechanisms of action with established standards of care, alongside exploring novel combination regimens designed to improve outcomes and deliver differentiated therapeutic benefits. BioNTech’s lung cancer portfolio includes both monotherapy approaches and combination strategies, targeting patients from early-stage disease through to advanced and metastatic settings.
According to Özlem Türeci, the upcoming ELCC presentations will further clarify the clinical potential of the company’s investigational therapies. She emphasized that the data not only strengthen confidence in BioNTech’s late-stage candidates but also provide important insights to guide ongoing and future development. The overarching goal, she noted, is to deliver transformative therapies capable of providing meaningful and durable benefits for patients living with lung cancer.
One of the central programs to be highlighted is pumitamig (BNT327/BMS986545), a bispecific immunomodulator developed in collaboration with Bristol Myers Squibb. This investigational therapy is designed to simultaneously inhibit PD-L1 immune checkpoint signaling while neutralizing VEGF-A, thereby targeting both immune evasion and tumor angiogenesis—two critical drivers of cancer progression.
Updated data from a Phase 2 clinical trial in China evaluating pumitamig in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) demonstrated encouraging antitumor activity and survival outcomes. ES-SCLC is an aggressive and fast-progressing subtype of lung cancer with limited treatment options, making these findings particularly noteworthy. The safety profile observed in the study was considered manageable, supporting further development. These results have helped inform the ongoing global Phase 3 ROSETTA Lung-01 trial, which aims to confirm the efficacy of this combination in a larger patient population.
In addition, new findings from a Phase 1b/2a study of pumitamig as a first-line monotherapy in advanced non-small cell lung cancer (NSCLC) showed promising antitumor activity regardless of PD-L1 expression levels. This is significant, as PD-L1 status often influences response to immunotherapy. The therapy demonstrated activity in both squamous and non-squamous NSCLC subtypes, along with a tolerable safety profile. These results complement the ongoing Phase 2/3 ROSETTA Lung-02 trial, which is evaluating pumitamig in combination with chemotherapy in the first-line NSCLC setting.
Further data from a Phase 2 trial in patients with EGFR-mutant advanced or metastatic NSCLC revealed clinically meaningful survival outcomes when pumitamig was combined with chemotherapy. Notably, the treatment showed potential benefit in patients who had previously progressed on EGFR tyrosine kinase inhibitors, a population with significant unmet need. The therapy’s activity appeared independent of PD-L1 expression, suggesting broader applicability across patient subgroups.
Another important program to be presented is gotistobart (BNT316/ONC-392), a next-generation immunotherapy developed in partnership with OncoC4. Gotistobart targets CTLA-4 and is designed to selectively deplete regulatory T cells within the tumor microenvironment, potentially enhancing antitumor immune responses while minimizing systemic toxicity.
Data from the dose-confirmation stage of the Phase 3 PRESERVE-003 trial in patients with previously treated squamous NSCLC demonstrated clinically meaningful antitumor activity. Importantly, the therapy was associated with an overall survival benefit, including a 54% reduction in the risk of death compared with standard chemotherapy. These results are particularly encouraging for patients who have already progressed after prior immunotherapy and chemotherapy, a setting where treatment options are limited. The safety profile was manageable, and the pivotal stage of the trial is currently ongoing.
BioNTech will also present the first clinical data for its HER3-targeted ADC candidate, BNT326/YL202, developed in collaboration with MediLink Therapeutics. In a Phase 2 study involving patients with advanced or metastatic NSCLC who had progressed following standard treatments, the ADC demonstrated signs of antitumor activity along with a favorable safety profile. These early results support continued development, including an ongoing Phase 1b/2 trial evaluating the combination of BNT326/YL202 with pumitamig, representing a novel “combination of innovative agents” approach.
Lung cancer remains one of the most challenging areas in oncology, with high mortality rates and substantial unmet medical need across all stages of disease. Recognizing this, BioNTech has made lung cancer a central focus of its oncology strategy. The company is advancing a broad and diversified pipeline that includes next-generation immunomodulators, ADCs, and mRNA-based cancer immunotherapies, as well as combinations of these modalities.
Currently, BioNTech is conducting 16 clinical trials in lung cancer, spanning multiple subtypes and treatment settings. This includes four pivotal Phase 3 trials and five studies exploring novel combinations of investigational therapies. Through this comprehensive development approach, the company aims to tackle the complexities of lung cancer biology and improve outcomes for patients from early-stage diagnosis through advanced disease.
The data to be presented at ELCC 2026 underscore BioNTech’s ambition to redefine lung cancer treatment by integrating cutting-edge science with clinically meaningful innovation. By advancing therapies that target multiple pathways involved in tumor growth and immune evasion, the company is working toward delivering more effective and personalized treatment options for patients worldwide.
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies.
Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, Pfizer and Regeneron.
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