BIONTECH SE · Data as of 2026-09-08
2026
Based on current event accrual projections, data are expected in 2026 from the first interim analysis of the Phase 3 part of the ongoing Phase 2/3 clinical trial (AHEAD-MERIT; NCT04534205 ) evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first-line treatment for patients with unresectable recurrent or metastatic, PD-L1+, HPV16+ HNSCC.Source filing
2026
Pivotal Phase 3 data expected in 2026Source filing
2026
While BioNTech and DualityBio plan to file a biologics license application ("BLA") in 2026, the companies will determine the optimal regulatory path for trastuzumab pamirtecan based on the totality of clinical data in endometrial cancer and breast cancer.Source filing
by year end
BioNTech expects to have 15 ongoing Phase 3 clinical trials in oncology by year end.Source filing
Q4 2026
Based on current event accrual projections, the primary analysis is expected in the fourth quarter 2026.Source filing
2027
Data read-out from the final analysis of this trial has been updated from 2026 to 2027, given that events have accrued more slowly than projected.Source filing
Sep 12–Sep 15
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 non-small cell lung cancer ("NSCLC") who progressed on prior PD-(L)1 inhibitor treatment will be presented.Source filing
Sep 12–Sep 15
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 NSCLC will be presented for this novel-novel treatment combination approach, underlining BioNTech's leadership in novel-novel combination treatment strategies.Source filing