BioNTech Books a Late-Breaking Slot in Seoul for the First Lung Cancer Data Pairing a PD-L1xVEGF Bispecific With an ADC

Both halves of the combination came from partners

The combination data come from a global Phase 1/2 trial in patients with advanced or metastatic small cell and non-small cell lung cancer, registered as NCT06892548. Elfetabart drozuntecan, shortened to elfe-D and coded BNT324/DB-1311, came to BioNTech through Duality Biologics; pumitamig, coded BNT327 and BMS-986545, is the asset Bristol Myers Squibb partnered. The release states no financial terms for either arrangement, gives no enrollment figure for the trial, and does not say which lung cancer subtype supplied most of the patients. BioNTech has released the slot itself: one oral, on the last day of the meeting.

Türeci calls the bispecific a backbone

Prof. Özlem Türeci, M.D., co-founder and chief medical officer at BioNTech, set the program against two goals at once, saying 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." She then tied the Seoul presentation to a wider claim about how the bispecific will be used:

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.

BioNTech has made that backbone claim ahead of any efficacy numbers, which the September 15 oral will supply.

Five more presentations behind the oral

Gotistobart, the CTLA-4 antibody BioNTech develops with OncoC4 and describes as selectively depleting regulatory T cells in the tumor microenvironment, takes a mini oral on September 14 (MO07.04) with updated overall survival from stage 1 of PRESERVE-003, NCT05671510, in squamous NSCLC after progression on a PD-(L)1 inhibitor. The second stage of that trial is ongoing. Pumitamig monotherapy appears twice in the trials-in-progress poster session on September 14: ROSETTA Lung-201 against durvalumab in unresectable stage III disease after chemoradiation (P2.330), and ROSETTA Lung-202 against pembrolizumab in locally advanced or metastatic NSCLC (P2.355). A September 13 mini oral (MO04.09) reports long-term progression-free and overall survival for first-line pumitamig with chemotherapy in unresectable malignant mesothelioma, and the mRNA immunotherapy BNT116 appears on September 14 (MO06.03) with preliminary Phase 1 results in resectable NSCLC alongside cemiplimab, carboplatin and paclitaxel.

No selection biomarker is named

Nothing in the announcement says whether the Phase 1/2 enrolled by PD-L1 score, by B7-H3 expression, or without a marker at all, and no assay or scoring cut-off is given for either target. ROSETTA Lung-202 is described only as locally advanced or metastatic NSCLC, without the PD-L1 threshold that determines how a monotherapy comparison against pembrolizumab should be read. Those specifics are left to the abstracts on the WCLC site and to the presentations themselves.

Why This Matters to the APO|APE Reader

Summit Therapeutics holds a PDUFA goal date of November 14, 2026 for ivonescimab, a PD-1xVEGF bispecific, on a HARMONi analysis that moved the Western-subgroup overall survival hazard ratio from 0.98 at the April 2025 primary cut to 0.76 at a June 2026 cut. A first US label in the class would put VEGF-directed bispecifics into laboratories that have validated PD-L1 immunohistochemistry only for single-agent checkpoint blockade, with no established scoring convention for a bispecific. BioNTech's Seoul data become the first read on whether stacking a B7-H3 ADC on top of that adds a second target to measure before treatment starts.