Clovis Oncology To Highlight Data For Its Three Portfolio Compounds At The ESMO Virtual Congress 2020

• Initial presentation of data from the Phase 1b part of the LIO-1 trial of lucitanib in combination with nivolumab in advanced metastatic solid tumors
• New data analyses for Rubraca^® (rucaparib) from the Phase 2 TRITON2 and Phase 3 ARIEL3 studies in patients with metastatic castration-resistant prostate cancer (mCRPC) and recurrent ovarian cancer, respectively
• First presentation of preclinical data for FAP-2286, a novel peptide-targeted radionuclide therapy (PTRT) being developed for the treatment of a variety of cancers

• Initial data from the Phase 1b part of the LIO-1 study in patients with an advanced metastatic solid tumor, which aimed to determine the recommended Phase 2 starting dose of lucitanib in combination with nivolumab and to provide safety, pharmacokinetic and preliminary efficacy data for the combination.
• A Trials in Progress e-poster describing the design of the Phase 2 part of the LIO-1 study, which is now enrolling patients, and will evaluate the combination’s safety and efficacy in patients with an advanced gynecological solid tumor, including ovarian, endometrial and cervical cancers.
• Analyses of pharmacokinetics and relationships between exposure and efficacy/safety in patients with metastatic castration-resistant prostate cancer (mCRPC) from the Phase 2 TRITON2 study of Rubraca, the primary analysis of which served as the pivotal data supporting FDA approval of Rubraca as the first poly-ADP ribose polymerase (PARP) inhibitor for patients with advanced mCRPC associated with a BRCA mutation.
• New analysis of data from the Phase 3 ARIEL3 study evaluating the prevalence, timing, and duration of adverse events for Rubraca maintenance therapy in recurrent ovarian cancer.
• Initial data from the Phase 1b part of the Phase 1b/2 SEASTAR study arm evaluating Rubraca in combination with sacituzumab govitecan for the treatment of metastatic solid tumors, which aims to evaluate the tolerability and preliminary efficacy for the combination.
• The first presentation of preclinical data inin vivoandin vitromodels for FAP-2286, a novel peptide-targeted radionucleotide therapy (PTRT) and imaging agent for which Clovis intends to file imaging and treatment Investigational New Drug applications to the FDA in late 2020.

“We have made significant progress in expanding the breadth and depth of our oncology development portfolio, including our pipeline compounds lucitanib and FAP-2286. We are excited to share new data and updates for all three compounds from our clinical and preclinical development programs at this year’s ESMO congress,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology.