6 August 2020 - - The first patient has been treated in the Phase 2 portion of the LIO-1 trial evaluating the combination of lucitanib, US-based Clovis Oncology, Inc's (NASDAQ: CLVS) investigational angiogenesis inhibitor, including vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), and Opdivo (nivolumab), Bristol Myers Squibb's (NYSE: BMY) PD-1 inhibitor, for the treatment of gynecologic cancers, the company said.

The LIO-1 trial is sponsored by Clovis as part of its broad clinical collaboration with Bristol Myers Squibb.

The Phase 2 part of LIO-1 is an open-label study to evaluate the safety and efficacy of lucitanib and Opdivo in patients with advanced gynecological solid tumors, including a broad spectrum of ovarian and endometrial subtypes including clear cell disease and patients with cervical cancer.

The primary endpoint is confirmed best overall response rate based on investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

The study will be conducted in the US and Europe, in collaboration with the European Network for Gynaecological Oncological Trial groups (ENGOT) for European study sites.

The Phase 2 dosing regimen for the LIO-1 study is based on results from the recently completed Phase 1b dose-escalation portion of the LIO-1 study.

Abstracts describing the initial results of the Phase 1b portion of the LIO-1 study, as well as a trials-in-progress description of the Phase 2 study design of LIO-1, have been accepted as ePosters at the European Society for Medical Oncology Virtual Congress 2020 in September.

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3).

Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications.

Angiogenic factors, such as vascular endothelial growth factor, are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment.

Use of antiangiogenic drugs may reverse this immunosuppression and augment response to immunotherapy.

Clovis Oncology is a biopharmaceutical company focused on acquiring, developing and commercialising innovative anti-cancer agents in the US, Europe and additional international markets.