Clovis Oncology, Inc. (Nasdaq: CLVS) announced today that the first clinical study of CO-1686 has commenced with the dosing of the first patient at a U.S. study site. CO-1686 is a novel, oral, targeted covalent inhibitor of epidermal growth factor receptor (EGFR) mutations currently being studied for the treatment of non-small cell lung cancer (NSCLC). The dose escalation portion of the Phase I/II study is being conducted at 5 sites in the U.S. and Europe, and the Company intends to initiate a parallel Phase I/II study in Asia during the third quarter of 2012. Following the establishment of the appropriate dose, Clovis intends to study CO-1686 in an expansion cohort of NSCLC patients who have failed EGFR-directed therapy, such as Tarceva ® or Iressa ®, and have developed the T790M mutation, which is the dominant resistance mechanism to Tarceva and Iressa. Clovis is developing a companion diagnostic in collaboration with Roche Molecular Systems, Inc. to identify patients with the T790M mutation. “While the development of EGFR tyrosine kinase inhibitor therapy for NSCLC patients with EGFR mutations has been a major advance, resistance develops after about a year and is a major obstacle lung oncologists face in the clinic each day,” said Lecia Sequist, Thoracic Medical Oncologist at Massachusetts General Cancer Center, Assistant Professor of Medicine at Harvard Medical School and an investigator in the study. “At the current time, there are no approved standard treatments available for patients with the T790M resistance mutation. Better solutions to this problem are desperately needed.” “CO-1686 is the first covalent inhibitor to enter the clinic designed to target both the activating mutations of EGFR and the resistance mutation T790M, and we are committed to working with our investigators to rapidly develop this compound,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology. “As has been presented at scientific meetings, CO-1686 is highly potent against these mutations of EGFR, including T790M, while sparing wild-type EGFR, and we are pleased to seek confirmation of these characteristics in patients.”
About CO-1686CO-1686 is a targeted covalent (irreversible) inhibitor of EGFR mutations. 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. CO-1686 is being clinically developed in patients with NSCLC associated with mutations in EGFR and has the potential to cause a lower incidence of skin rash and diarrhea, the primary toxicities associated with other EGFR inhibitors. Preclinical data presented in late 2011 demonstrated that CO-1686 causes tumor shrinkage in T790M-driven NSCLC xenograft models, and resulted in significant tumor growth inhibition at a variety of doses. About EGFR and Lung Cancer Lung cancer is the most common cancer worldwide with 1.35 million new cases annually, with NSCLC accounting for almost 85 percent of all lung cancers. NSCLC progresses rapidly with a five-year survival rate in advanced NSCLC patients of less than five percent. EGFR activating mutations occur in approximately 10 to 15 percent of NSCLC cases in Caucasian patients and approximately 30 to 35 percent in East Asian patients. These patients experience significant tumor response to Tarceva and Iressa, which are first-generation EGFR inhibitors. However, most patients ultimately progress on Tarceva and Iressa therapy, with approximately 50 percent of patients developing acquired resistance from a second, or “gatekeeper” mutation, T790M. 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 CO-1686 and our other product candidates, the corresponding development pathways of our companion diagnostics, 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. A further description of risks and uncertainties can be found in Clovis Oncology’s Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.