“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 Chief Medical Officer 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.”
Highlights of BioNTech’s lung cancer programs to be presented at ELCC 2026:
Pumitamig (BNT327/BMS986545) – a bispecific immunomodulator candidate combining PD-L1 checkpoint inhibition and VEGF-A neutralization, developed in collaboration with Bristol Myers Squibb Company (“BMS”):
- 1L ES-SCLC: Updated follow-up data from a single-arm Phase 2 clinical trial (NCT05844150) conducted in China continued to show encouraging preliminary antitumor activity and survival outcomes, together with a manageable tolerability profile for pumitamig plus chemotherapy as first-line therapy in patients with extensive-stage small cell lung cancer (“ES-SCLC”), an aggressive subtype of lung cancer. The data support the ongoing pivotal global Phase 3 ROSETTA Lung-01 clinical trial (NCT06712355) in first-line ES-SCLC.
- 1L NSCLC: New findings from a Phase 1b/2a clinical trial (NCT05918445) conducted in China showed preliminary antitumor activity irrespective of PD-L1 expression levels and a manageable safety profile for pumitamig as first-line monotherapy in both squamous and non-squamous advanced non-small cell lung cancer (“NSCLC”). The results complement the ongoing global Phase 2/3 ROSETTA Lung-02 clinical trial (NCT06712316) evaluating the combination of pumitamig with chemotherapy in first-line NSCLC.
- EGFR-mutant NSCLC: Data from a Phase 2 clinical trial (NCT05756972) conducted in China showed clinically meaningful survival outcomes and a manageable safety and tolerability profile for pumitamig combined with chemotherapy in patients with EGFR-mutant advanced or metastatic NSCLC, regardless of PD-L1 expression level. These data highlight its potential in patients progressing on EGFR tyrosine kinase inhibitors.
Gotistobart (BNT316/ONC-392) – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4 and developed in collaboration with OncoC4, Inc. (“OncoC4”):
- 2L+ squamous NSCLC: Data from the non-pivotal, dose-confirmation stage 1 portion of the global Phase 3 PRESERVE-003 clinical trial (NCT05671510) showed clinically meaningful antitumor activity, an overall survival benefit with a 54% reduction in the risk of death compared with standard of care chemotherapy, and a manageable safety profile for gotistobart in patients with squamous NSCLC who have progressed on prior immunotherapy plus chemotherapy. The pivotal stage of the Phase 3 clinical trial is ongoing.
BNT326/YL202 – a HER3-targeted ADC candidate developed in collaboration with MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink”):
- NSCLC: First clinical data from the NSCLC cohort of a Phase 2 clinical trial with BNT326/YL202 (NCT06107686) conducted in China showed antitumor activity and a favorable safety profile in patients with advanced or metastatic NSCLC who progressed after standard of care therapy. The findings support the ongoing Phase 1b/2 clinical trial (NCT07070232) evaluating the novel combination of pumitamig and BNT326/YL202.
Lung cancer is among BioNTech’s tumor focus areas, as the Company aims to address the significant unmet medical needs in the treatment of patients with lung cancer. BioNTech is advancing a diversified and robust clinical development approach in lung cancer spanning investigational next-generation immunomodulators, antibody-drug conjugates, mRNA cancer immunotherapies, and their combinations. With 16 ongoing clinical trials across various lung cancer subtypes and lines of treatment, including four ongoing pivotal Phase 3 clinical trials and five ongoing novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of lung cancer treatment from early to late-stage conditions.
The abstracts are available on the ELCC Congress website. Click here for further information on BioNTech’s lung cancer portfolio.
Full presentation details:
