The interim data from the signal-seeking cohort of patients with recurrent ovarian cancer demonstrates an overall response rate (ORR) of 24%, which represents a meaningful improvement over pembrolizumab monotherapy, states the company.

Preclinical studies demonstrated synergistic anti-tumor activity when BI-1808 was combined with pembrolizumab, providing a strong rationale for advancing this combination into clinical development. Ovarian cancer is an exciting prospect for the combination Phase 2a signal-seeking cohort given a complete response (CR) was observed in a platinum-resistant patient treated with BI-1808 monotherapy, highlighting the potential of targeting this difficult-to-treat population.

“Recurrent ovarian cancer has few options after platinum failure and a history of unsuccessful attempts to develop chemotherapy-free immunotherapy approaches,” says Martin Welschof, CEO, 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.”