BioInvent International’s lead immuno-oncology candidate, BI-1808, has demonstrated promise in the Phase IIa KEYNOTE-D20 study (NCT04752826) in recurrent ovarian cancer.
Alongside MSD’s best-selling cancer drug, Keytruda (pembrolizumab), BI-1808 triggered an overall response rate (ORR) of 24%, with 11 out of 17 (65%) of patients achieving disease control following treatment.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
This compares with the 7.4% to 9.9% ORR range observed in the Phase II KEYNOTE-100 study (NCT02674061), where Keytruda was evaluated as a monotherapy.
Of the 11 patients experiencing disease control, four exhibited partial responses to treatment with BI-1808 plus Keytruda, while seven achieved disease stabilisation (DS), with some DS responses lasting more than eight months.
These treatment effects were observed in patients who had previously progressed following treatment with platinum-based chemotherapy, which is currently the standard of care (SoC) for first-line treatment alongside surgical resection.
According to BioInvent, the combination was found to be effective in both clear cell and high-grade serous ovarian cancer subtypes – highlighting the drug’s potential across a broad subset of patients with this solid tumour type.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataTreatment with the tumour necrosis factor receptor 2 (TNFR2)-targeting monoclonal antibody (mAb) plus Keytruda was also found to be safe and tolerable, though BioInvent has not yet provided specific data around the drug’s safety profile within this Phase IIa study.
To further explore the potential of BI-1808 in ovarian cancer, BioInvent will conduct a Phase IIa expansion study, which will include 20 additional patients with clear cell and high-grade serous ovarian cancer to further consolidate the combination’s efficacy in these patient groups. A readout for this expansion phase is expected in the second half of 2026.
Addressing unmet needs in ovarian cancer
Ovarian cancer is an area of high unmet need, with frontline SoC still relying on platinum-based chemotherapy.
While the pharma industry has been looking to develop immunotherapies in this indication, many have failed to meet the mark, as this solid tumour type is often unresponsive due to its complex tumour microenvironment.
Despite this, biotech and pharma companies are continuing to explore the potential of such treatment options within ovarian cancer.
This led to Keytruda plus chemotherapy – with or without Roche-owned Genentech’s Avastin (bevacizumab) – becoming the first immunotherapy combination to deliver statistically significant progression-free survival (PFS) benefits in platinum-resistant ovarian cancer in the KEYNOTE-B96 study (NCT05116189).
Meanwhile, Verastem Oncology’s Raf/MEK inhibitor, avutometinib, demonstrated an ORR of 31% alongside defactinib in recurrent low-grade serous ovarian cancer in the Phase II RAMP 201 trial (NCT04625270). In May 2025, the combination obtained accelerated US approval for the treatment of patients with KRAS-mutated disease.
Outside of the immunotherapy umbrella, Corcept Therapeutics’ selective glucocorticoid receptor antagonist, relacorilant, has shown promise in the Phase III ROSELLA trial, with topline results suggesting the drug can enhance chemotherapy sensitivity while boosting outcomes for patients with various types of ovarian and fallopian tube cancers.
This effect was also observed in patients previously exposed to PARP inhibitors – a common maintenance treatment option in the frontline ovarian cancer setting.
According to GlobalData, parent company of Clinical Trials Arena, the ovarian cancer market was worth $3.3bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) in 2022.
