BioInvent’s BI-1808 received FDA Fast Track Designation for ovarian cancer after showing a 24% response rate and 56% disease control rate.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration has granted Fast Track Designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of ovarian cancer in combination with pembrolizumab. The designation supports accelerated development and regulatory interaction for a therapy being evaluated in a setting with substantial unmet need.
The clinical rationale centers on overcoming limited activity from PD-1 blockade alone in recurrent platinum-resistant ovarian cancer. BioInvent cited an historical response rate of about 8% with pembrolizumab monotherapy in this population.
BI-1808 Targets Immunosuppressive Tumor Biology
BI-1808 targets tumor necrosis factor receptor 2 (TNFR2), which is highly expressed on regulatory T cells (Tregs) within the tumor microenvironment. The antibody is engineered to engage Fcγ receptors and deplete immunosuppressive Tregs while also reprogramming myeloid cells.
This approach could enhance antitumor immunity by improving the activity of CD8-positive T cells and complementing PD-1 blockade. Preclinical studies have shown antitumor activity across multiple syngeneic tumor models and enhanced effects when combined with anti-PD-1 therapy.
Phase 2a Data Show Activity in Platinum-Resistant Ovarian Cancer
The ovarian cancer data come from the ongoing Phase 2a study (NCT04752826), which evaluates BI-1808 as monotherapy and in combination regimens.
In the interim dataset presented at ASCO 2026, BI-1808 plus pembrolizumab, without chemotherapy, produced a 24% confirmed overall response rate (ORR) and a 56% disease control rate (DCR) among heavily pretreated patients with advanced platinum-resistant ovarian cancer.
Responses and disease control were observed across high-grade serous and clear cell ovarian cancer subtypes. Several patients-maintained responses beyond 10 months, while prolonged stable disease was also reported. Preliminary analysis showed a median progression-free survival of 10.3 months.
The company did not report comparative statistical testing in the supplied data, and the findings remain from an interim Phase 2a analysis rather than a randomized confirmatory study.
Expansion Focuses on High-Grade Serous and Clear Cell Disease
The Phase 2a trial includes three treatment components: BI-1808 monotherapy, BI-1808 plus pembrolizumab, and a triple combination of BI-1808, pembrolizumab and paclitaxel. Investigators are evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, ORR, duration of response and progression-free survival using RECIST v1.1 and iRECIST criteria.
Cohort expansion is now focusing on high-grade serous and clear cell ovarian cancer. Additional clinical data are expected in the second half of 2026.
Development Partnership With MSD
BioInvent has collaborated with MSD since August 2021 under a clinical trial collaboration and supply agreement to evaluate BI-1808 with pembrolizumab, marketed as KEYTRUDA.
CEO Martin Welschof said the Fast Track designation reflects both the unmet need in ovarian cancer and the clinical signals observed to date. He highlighted the activity seen in high-grade serous and clear cell disease as support for continued evaluation of TNFR2 targeting alongside PD-1 inhibition.
The next data readout from the expanded cohorts will provide an important test of whether the initial response and disease-control signals can be reproduced in defined ovarian cancer subtypes and sustained with further follow-up.
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About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.