BioNTech says partial clinical hold on BNT316 study lifted

BioNTech (BNTX) said it has been informed by its partner OncoC4 that the Food and Drug Administration has lifted the partial clinical hold on PRESERVE-003, a two-stage, open-label, randomized Phase 3 trial evaluating the efficacy and safety of BNT316/ONC-392 as monotherapy in patients with metastatic non-small cell lung cancer that progressed under previous PD-(L)1-inhibitor treatment. “Based on the available trial data and following an alignment with the FDA, the companies will solely continue enrollment of patients with squamous NSCLC,” BioNTech disclosed in a regulatory filing. The partial clinical hold on the study was previously announced by BioNTech on October 18, following OncoC4’s communication to the FDA after an assessment of the trial data by the independent Data Monitoring Committee which identified a possible variance in results between the squamous and non-squamous NSCLC patient populations. The partial clinical hold only affected new patient enrollment and did not impact patients already enrolled in the trial. Trials evaluating BNT316/ONC-392 in other indications also remained unaffected.