The FDA has implemented a partial hold on a phase 3 non-small cell lung cancer trial run by BioNTech and OncoC4 after seeing varying results among patients.
The hold impacts an open-label trial, dubbed PRESERVE-003, which is assessing CTLA-4 inhibitor gotistobart (also known as BNT316/ONC-392), according to a Securities and Exchange Commission (SEC) document filed Oct. 18.
BioNTech and OncoC4 “understand” that the partial hold “is due to varying results between the squamous and non-squamous NSCLC patient populations,” according to the SEC document.
After a recent assessment conducted by an independent data monitoring committee detected a potential variance, the partners voluntarily paused enrollment of new patients and reported the possible variance to the FDA.
Now, the regulatory agency has implemented a partial halt. The trial is measuring if the antibody can prolong life, as compared to chemotherapy, among patients with metastatic NSCLC that has progressed after previous PD-L1 treatment.
Patients already enrolled in PRESERVE-003 will continue to receive treatment, according to the SEC filing. The study began recruiting last summer and intends to enroll a total of 600 patients, according to ClinicalTrials.gov.
Other trials evaluating gotistobart—which include a phase 2 Keytruda combo study in ovarian cancer, plus two earlier stage trials in prostate cancer and solid tumors—aren’t affected by the partial hold.
Gotistobart is a next-gen anti-CTLA-4 candidate designed to kill cancer with fewer immune-related adverse effects and a more favorable safety profile.
In March 2023, BioNTech paid OncoC4 $200 million upfront for exclusive licensing rights to the asset. The deal is part of the German company’s broader push into oncology, with a large focus centering around its off-the-shelf, indication-specific mRNA cancer vaccine platform.