Clovis Oncology (NASDAQ: CLVS) announced today that the Company signed an agreement with QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) to develop a companion diagnostic test to identify the T790M resistance mutation in patients with epidermal growth factor receptor (EGFR) driven non-small cell lung cancer (NSCLC) for CO-1686. The diagnostic will build on QIAGEN’s therascreen ® EGFR RGQ PCR Kit, which was approved by the U.S. Food and Drug Administration (FDA) in July 2013 as a companion diagnostic used in the treatment of metastatic NSCLC in patients whose tumors have certain EGFR mutations. Analytical performance of the therascreen EGFR test has been established for 21 EGFR mutations, including the most prevalent resistance mutation (T790M). Terms of the agreement were not disclosed. “As we continue development of CO-1686 for patients with mutant EGFR-driven non-small cell lung cancer, we are pleased to collaborate with QIAGEN for the development of a companion diagnostic for CO-1686,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “Importantly, QIAGEN’s test is already FDA approved to reliably and accurately detect EGFR mutations, including T790M, which complements our accelerated plan for CO-1686 clinical development by potentially allowing for a supplemental premarket approval (PMA) filing.” “We are pleased that Clovis has selected the therascreen EGFR test as its companion diagnostic solution of choice for CO-1686,” said Peer M. Schatz, QIAGEN’s Chief Executive Officer. “The decision provides further confirmation for the therascreen technology’s leadership in companion diagnostics. We look forward to working with Clovis to contributing the benefits of personalized healthcare to all stakeholders involved: for pathologists, oncologists, payers and – most importantly – for patients.” The diagnostic test is now being further developed in parallel with the clinical development of CO-1686, with the goal of filing a supplemental PMA application with the FDA in a time frame that would allow for regulatory approval of the companion diagnostic concurrent with CO-1686 approval. The Company intends to begin using the QIAGEN test in its Phase II expansion cohorts, the first of which is expected to begin enrolling in late 2013.
In addition to the collaboration on CO-1686, both partners have signed a non-exclusive Master Collaboration Agreement which will enable additional Clovis assets requiring supporting companion diagnostic assays to be rapidly developed using QIAGEN sample and assay technologies where appropriate.About CO-1686 CO-1686 is a novel, oral, targeted covalent (irreversible) inhibitor of the cancer-causing mutant forms of epidermal growth factor receptor (EGFR) currently being studied for the treatment of non-small cell lung cancer (NSCLC). CO-1686 was designed to selectively target both the initial activating EGFR mutations as well as the T790M resistance mutation, while sparing wild-type, or “normal” EGFR at anticipated therapeutic doses. Accordingly, it has the potential to treat NSCLC patients with EGFR mutations both as a first-line or second-line treatment with a reduced toxicity profile compared to current EGFR inhibitor therapies. The Phase I/II study is currently in the dose escalation phase, being conducted in the U.S., France and Australia. Following the establishment of an appropriate dose, the Company intends to study CO-1686 in Phase II expansion cohorts of NSCLC patients with activating EGFR mutations who have failed initial EGFR-directed therapy and have developed the T790M resistance mutation as well as NSCLC treatment-naïve patients with activating EGFR mutations. 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. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK. 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 our clinical development programs for rucaparib, the corresponding development strategies for companion diagnostics for our product candidates, actions by the FDA, the EMA or other regulatory authorities regarding whether to approve drug applications that may be filed, as well as their decisions regarding drug labeling, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics, including competitive developments. Clovis Oncology does not undertake 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, 2012 and its other reports filed with the Securities and Exchange Commission.