FDA puts partial clinical hold on gotistobart trial

The US Food and Drug Administration (FDA) has placed a partial clinical hold on the two-stage, open-label, randomized Phase III trial, PRESERVE-003 (NCT05671510).

BioNTech (Nasdaq: BNTX) and partner USA-based OncoC4 understand that the partial clinical hold in the ongoing Phase III trial with BNT316/ONC-392 (gotistobart) in non-small cell lung cancer (NSCLC) is due to varying results between the squamous and non-squamous NSCLC patient populations, the German biotech disclosed in a Securities and Exchange Commission (SEC) filing. BioNTech’s shares dipped 3% to $111.11 on the news.

The trial evaluates the efficacy and safety of the antibody candidate BNT316/ONC-392 as monotherapy in patients with metastatic NSCLC that progressed under previous PD-(L)1-inhibitor treatment. A recent assessment of the trial data by the independent data monitoring committee identified a possible variance in population results. Consequently, OncoC4 and BioNTech decided to proactively pause enrollment of new patients and informed the FDA of the possible variance for further alignment.