BioInvent International has reported encouraging interim results from its Phase 2a study testing BI-1808, a novel immuno-oncology candidate, in combination with MSD’s KEYTRUDA (pembrolizumab) in patients with recurrent ovarian cancer.
The early data show an overall response rate (ORR) of 24%, a significant improvement over pembrolizumab alone, which historically achieves only an 8% ORR in this population. The disease control rate (DCR) reached 65%, with 4 patients showing partial responses and 7 patients experiencing stable disease, some persisting beyond eight months.
“Recurrent ovarian cancer has few options after platinum failure and a history of unsuccessful attempts to develop chemotherapy-free immunotherapy approaches,” said Martin Welschof, Chief Executive Officer of BioInvent.
"Pembrolizumab has shown meaningful benefit only when combined with chemotherapy, while monotherapy in the KEYNOTE-100 study achieved an ORR of 8%. Against this backdrop, observing a 24% response rate and a 65% disease control rate with BI-1808 in combination with pembrolizumab is highly encouraging and has led us to expand this cohort to better qualify this signal.
"These results suggest that our combination could deliver a new immuno-oncology option for patients who urgently need better alternatives, and we look forward to reporting more data going forward.”
Treatment options for recurrent ovarian cancer remain extremely limited, particularly after platinum-based therapies fail. Preclinical studies suggested that BI-1808 and pembrolizumab act synergistically, a rationale now supported by clinical results. Notably, a complete response was previously observed in a platinum-resistant patient treated with BI-1808 alone, highlighting the therapy’s potential in difficult-to-treat cases.
The combination therapy was generally safe and well-tolerated, with adverse events manageable using standard medical approaches. BioInvent has enrolled 23 patients to date, evaluating 17 so far, with ongoing follow-up to assess longer-term responses and progression-free survival.
