On October 18, 2024 BioNTech SE ("BioNTech") reported that it has been informed by its partner OncoC4, Inc. ("OncoC4") that the U.S. Food and Drug Administration ("FDA") has placed a partial clinical hold on the companies’ two-stage, open-label, randomized Phase 3 trial, PRESERVE-003 (NCT05671510) (Press release, BioNTech, OCT 18, 2024, View Source [SID1234647263]). BioNTech and OncoC4 understand that the partial clinical hold in the ongoing Phase 3 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.
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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.
About BNT316/ONC-392 (gotistobart)
BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 antibody candidate jointly being developed by BioNTech and OncoC4. BNT316/ONC-392 is currently in late-stage clinical development as monotherapy or combination therapy in various cancer indications. The immune checkpoint receptor CTLA-4 inhibits T cell immune response and reduces the activity of T cells in recognizing and eliminating cancer cells. This mechanism is also exploited by cancer cells to prevent them from being eliminated by T cells. Blocking CTLA-4 may help to preserve T cell activity and enhance anti-tumor activity. BNT316/ONC-392 was designed with the aim to address this mechanism while preserving CTLA-4 recycling and thus the immunosuppressive T cell (regulatory T cells, or "Tregs") function in the peripheral tissues. This approach aims to give rise to fewer immune-related adverse effects and a more favorable safety profile. The PRESERVE-003 trial (NCT05671510), which is the subject of the partial clinical hold, is a registrational Phase 3 trial to evaluate the candidate as monotherapy in patients with metastatic non-small cell lung cancer (NSCLC). In addition, the candidate is being evaluated in a Phase 2 trial as a combination therapy with pembrolizumab in platinum-resistant ovarian cancer (NCT05446298), in a Phase 1/2 trial in metastatic castration-resistant prostate cancer (NCT05682443) as well as in a Phase 1/2 trial in multiple solid tumors (NCT04140526).