On August 5, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) announced today treatment of the first patient in the Phase 2 portion of the LIO-1 trial evaluating the combination of lucitanib, Clovis’ investigational angiogenesis inhibitor, including vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), and Opdivo (nivolumab), Bristol Myers Squibb’s PD-1 inhibitor, for the treatment of gynecologic cancers (Press release, Clovis Oncology, AUG 5, 2020, View Source [SID1234562876]). The LIO-1 trial is sponsored by Clovis as part of its broad clinical collaboration with Bristol Myers Squibb.

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"The Phase 2 part of the LIO-1 trial will advance our scientific understanding of the potential for an inhibitor of multiple tyrosine kinases, including VEGF, such as lucitanib, to be combined with a PD-1 inhibitor for the treatment of gynecologic cancers," said Dr. Erika Hamilton, Director of the Breast and Gynecologic Research Program, Sarah Cannon Research Institute at Tennessee Oncology. "It is estimated that nearly 100,000 women will be diagnosed with a gynecologic cancer in the U.S. this year alone, and it is vital that we identify new treatment options, in particular new combinations, for these women."

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 U.S. 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 (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 in September.

"The initiation of the Phase 2 stage of the LIO-1 clinical trial is an important milestone for the lucitanib development program, and I am grateful to our team and our investigators for their commitment to initiating this study safely and expeditiously in this new COVID-19 era," said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. "Importantly, we look forward to sharing initial Phase 1b data from LIO-1 at the upcoming virtual ESMO (Free ESMO Whitepaper) Congress, as well as data for each of our commercial and development-stage products. We are committed to pursue innovative clinical studies, both monotherapy and in combination, that are supported by a strong scientific rationale and offer the potential to provide additional treatment options with meaningful clinical benefit to a broad group of cancer patients."

More information about the LIO-1 trial (NCT04042116) is available here.

About Lucitanib

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 (VEGF), 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.

Lucitanib is an unlicensed medical product.