gotistobart (also known as BNT316 or ONC-392) — Clinical data readout
2026
Pivotal Phase 3 data expected in 2026Source filing
catalyst calendar
BIONTECH SE · Data as of 2026-10-27
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
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
Oct 23–Oct 27
Oct 23 - 27, 2026Source filing