BioNTech Highlights Late-Stage Lung Cancer Pipeline Momentum and First Global Data for Pumitamig/Elfetabart Drozuntecan Novel-Novel Combination at WCLC 2026
2026-08-20 · BioNTech SE · original biontech.com ↗
MAINZ, Germany, August 20, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data from its diversified development program in lung cancer treatment at the International Association for the Study of Lung Cancer (“IASLC”) 2026 World Conference on Lung Cancer (“WCLC”) in Seoul, Republic of Korea, from September 12-15, 2026. The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate (“ADC”) elfetabart drozuntecan (elfe-D or BNT324/DB-1311), representing the first combination data for any PD-(L)1xVEGF bispecific immunomodulator and an ADC in lung cancer. “Progress in lung cancer care means both improving treatment outcomes for patients and, importantly, finding better options for more patients who still do not sufficiently benefit from current standard therapies,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech . “The data we are presenting at this year’s WCLC provide further clinical evidence for our late-stage assets, gotistobart and pumitamig, and help to define the role of next-generation immunomodulators in addressing unmet medical needs in lung cancer. We are also presenting the first clinical evidence from a novel-novel treatment combination in lung cancer as part of our evaluation of pumitamig as a potential backbone for combination strategies of complementary mechanisms. Taken together, these data will inform the next steps in our clinical development programs and our broader efforts to expand treatment options for patients.” Highlights from BioNTech’s presentations at WCLC 2026: Novel-novel combination trial of pumitamig, developed in collaboration with Bristol Myers Squibb Company (“BMS”), and elfetabart drozuntecan, developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”): Advanced/metastatic SCLC and NSCLC : First data from the global Phase 1/2 trial ( NCT06892548 ) evaluating pumitamig in combination with the B7H3-targeting ADC elfetabart drozuntecan in patients with advanced or metastatic small cell lung cancer (“SCLC”) and non-small cell lung cancer ("NSCLC") will be presented for this novel-novel treatment combination approach, underlining BioNTech’s leadership in novel-novel combination treatment strategies. Gotistobart – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. (“OncoC4”): 2L+ squamous NSCLC : Updated overall survival data from stage 1 of the PRESERVE-003 Phase 3 clinical trial ( NCT05671510 ) of gotistobart in patients with squamous NSCLC who progressed on prior PD-(L)1 inhibitor treatment will be presented. The results further contribute to the growing body of evidence for this chemotherapy-free treatment approach. The pivotal stage 2 part of the trial is ongoing. All abstracts are available through the WCLC website . Further information on BioNTech’s lung cancer pipeline can be accessed here . Full presentation details: Candidate Abstract Title Abstract Number/Presentation Details Pumitamig + elfetabart drozuntecan Pumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients with Advanced/Metastatic Lung Cancer (NSCLC or SCLC) Abstract #OA14.01 Oral Presentation The Breakthrough Immunotherapy for Advanced NSCLC Sep 15, 2026: 12:30 - 01:45pm KST Pumitamig First-line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-term PFS and OS Abstract #MO04.09 Mini Oral Novel Therapeutics and Molecular Insights in Thymic Malignancies and Pleural Mesothelioma Sep 13, 2026: 4:45 - 6:00pm KST ROSETTA Lung‑201: A Phase 3 Trial of Pumitamig Monotherapy vs Durvalumab in Unresectable Stage III NSCLC Post-Chemoradiation Abstract #P2.330 Poster Clinical Trials in Progress Sep 14, 2026: 10:30am - 12:00pm KST ROSETTA Lung-202: A Phase 3 trial of first-line pumitamig monotherapy vs pembrolizumab in locally advanced/metastatic NSCLC Abstract #P2.355 Poster Clinical Trials in Progress Sep 14, 2026: 10:30am - 12:00pm KST Gotistobart Gotistobart vs Docetaxel in Metastatic Squamous NSCLC After PD-(L)1 Progression: Updated Overall Survival of the stage 1 of PRESERVE-003 Abstract #MO07.04 Mini Oral Novel Immunotherapeutic Strategies in mNSCLC Sep 14, 2026: 5:00 - 6:15pm KST BNT116 Neoadjuvant BNT116 + Cemiplimab + Carboplatin + Paclitaxel in Resectable NSCLC: Preliminary Results From a Phase I Trial Abstract #MO06.03 Mini Oral Emerging Precision Approaches in Perioperative Therapy for Resectable NSCLC Integrating Targeted Therapy, Immunotherapy, Biomarkers, and Multimodal Strategies Sep 14, 2026: 3:30 - 4:45pm KST
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