F-star announces publication of Phase 1 dose-escalation trial of FS118

F-star Therapeutics announced the publication of safety and efficacy results from Phase 1 trial of FS118 in patients with advanced cancer and PD-L1 resistance in Clinical Cancer Research, a journal of the American Association for Cancer Research. "Phase 1 data published in Clinical Cancer Research demonstrate that FS118 has the potential to overcome cancer immune resistance given the prolonged pharmacodynamic activity," said Louis Kayitalire, Chief Medical Officer of F-star. "We are pleased to see that FS118 was well-tolerated, and in this population of heavily pre-treated patients with PD-L1 acquired resistance achieved one partial response and 54.8% disease control rate. We look forward to generating additional data and leveraging our bispecific approach to provide therapies for patients with advanced cancer." The Phase 1 trial is the first-in-human study of FS118 that is evaluating forty-three patients with locally advanced/metastatic cancer with a median of three prior regimens therapy and at least one anti-PD-L1 regimen. Patients received intravenous FS118 monotherapy weekly with an accelerated dose titration design followed by 3+3 ascending dose expansion. Weekly administration was well tolerated, with no dose-limiting toxicities (DLTs), and no serious adverse events relating to FS118. The recommended Phase 2 dose of FS118 was established at 10 mg/kg weekly.