Hutchmed has initiated a phase Ib/II study of fruquintinib in combination with BeiGene’s tislelizumab in patients with advanced triple negative breast cancer (TNBC) or advanced endometrial cancer (EC) in the US. The first patient was dosed on August 24, 2021. This trial is to explore the potential for the addition of a highly selective vascular endothelial growth factor receptor (VEGFR) inhibitor, fruquintinib, to anti-programmed death-1 (PD-1) antibody tislelizumab in inducing activity to immune checkpoint inhibitors.
This is an open-label, multi-center, non-randomized study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic TNBC or advanced EC. This study will be conducted in two parts: a safety lead-in phase (Part 1) and a dose expansion phase (Part 2). The safety lead-in phase will determine safety and tolerability and the recommended Phase II dose (RP2D) of the combination. In the dose expansion phase, the RP2D will be administered to two cohorts of patients: Cohort A – Patients with TNBC who have received prior therapy with an immune checkpoint inhibitor; and Cohort B – Patients with TNBC who have not received prior therapy with an immune checkpoint inhibitor. A cohort evaluating the combination in second line advanced EC is anticipated to open in 3Q2021.
Breast cancer is a common type of cancer in the US, estimated to be diagnosed in over 281,000 women during 2021. TNBC is one of several subtypes of breast cancer, accounting for approximately 10% of newly diagnosed breast cancer cases.
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.
Hutchmed retains all rights to fruquintinib outside of China. In China, Hutchmed is partnered with Eli Lilly and Company and is responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing