Clovis Oncology Announces First Patient Enrolled in Lucitanib Phase 2 Study in Squamous Non-small Cell Lung Cancer

Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that its global Phase 2 study of lucitanib in patients with FGFR1-amplified squamous non-small cell lung cancer (NSCLC) has commenced and the first patient has been dosed at a U.S. study site. Lucitanib is the Company’s oral, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 through 3 (FGFR1-3), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFR α-ß).

“The lucitanib data presented to date in patients with FGF-aberrant breast cancer are very encouraging, and we know that FGFR1 amplification occurs in approximately 15 percent of patients with squamous non-small cell lung cancer,” said Dr. Benjamin Besse, Head of Thoracic Oncology, Institut Gustave Roussy, and the lead investigator of the study in squamous NSCLC. “Accordingly, we are very enthusiastic to explore lucitanib in this selected population of patients with lung cancer, for whom there is significant need for novel therapies.”

“Less than a year after acquiring lucitanib, we are commencing a broad clinical development program, which includes this study in FGFR1-amplified squamous NSCLC, as well as our ongoing study currently underway in FGF-aberrant breast cancer,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We are enthusiastic about the opportunity to explore lucitanib in these indications, and potentially in other solid tumors exhibiting FGFR pathway activation.”

The Phase 2 study will enroll FGFR1-amplified squamous NSCLC patients with advanced disease who have progressed on at least one prior line of therapy. The global study will assess objective response rate, progression-free survival, and duration of response, as well as the safety, tolerability, and pharmacokinetics of lucitanib.

Lucitanib is unique among tyrosine kinase inhibitors being developed for cancer therapy, as it effectively targets fibroblast growth factor receptors (FGFR)1-3, vascular endothelial growth factor receptors (VEGFR)1-3, and platelet-derived growth factor receptors (PDGFR) alpha and beta with minimal off-target activity. This selectivity profile allows lucitanib to provide a potential benefit to cancer patients by targeting multiple pathways of tumor development. Specifically, by targeting the FGFR pathway, lucitanib can have a direct antitumor effect in FGF/FGFR driven tumors such as breast or lung cancers harboring amplification of the FGFR1 gene. In addition, by targeting the FGFR, VEGFR and PDGFR receptors lucitanib also can inhibit the development of blood vessels that are required by the tumor to grow and spread.

In addition to this Clovis-sponsored Phase 2 study in squamous NSCLC, a global development program for lucitanib in breast cancer is underway, which includes the Clovis-sponsored Phase 2 study in FGF-aberrant advanced breast cancer being conducted in the U.S., the Servier-sponsored FINESSE study of lucitanib monotherapy being conducted in Europe, Canada and Australia as well as the Servier-sponsored INES study evaluating lucitanib in combination with fulvestrant after failure of endocrine therapy.

About FGF-aberrant Squamous NSCLC

Lung cancer is the most common cancer worldwide with 1.7 million new cases annually, with NSCLC accounting for almost 85 percent of all lung cancers. Squamous non-small cell lung carcinoma is a sub-type of NSCLC derived from the cells which line the lung’s major airways. Squamous NSCLC accounts for approximately 25-30 percent of lung cancer cases, and is generally diagnosed in patients with a history of smoking. FGFR1-amplification is a hallmark of squamous NSCLC and observed in roughly 15 percent of squamous NSCLC tumors. There are no approved targeted therapies specifically for patients with squamous NSCLC.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 through 3 (FGFR1-3), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFR α-ß). Clovis owns exclusive development and commercial rights to lucitanib on a global basis, excluding China. Lucitanib rights to markets outside of the U.S. and Japan have been sublicensed to Servier. Clovis is collaborating with Servier on the global clinical development of lucitanib.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology’s Annual Report on Form 10-K for the year ended December 31, 2013 and its other reports filed with the Securities and Exchange Commission.