BioNTech: FDA puts partial clinical hold on Phase 3 PRESERVE-003 trial

In a regulatory filing, BioNTech (BNTX) said that it has been informed by its partner OncoC4 that the U.S. FDA has placed a partial clinical hold on the companies’ two-stage, open-label, randomized Phase 3 trial, PRESERVE-003. BioNTech and OncoC4 understand that the partial clinical hold in the ongoing Phase 3 trial with BNT316/ONC-392 in non-small cell lung cancer is due to varying results between the squamous and non-squamous NSCLC patient populations. 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. While the companies are assessing next steps for the ongoing trial with BNT316/ONC-392 in NSCLC, patients already enrolled in the trial will continue to receive treatment. Trials evaluating BNT316/ONC-392 in other indications remain unaffected.