clovis oncology inc (CLVS) Snapshot

Clovis Oncology, Inc. announced the addition of two new members to its Board of Directors, Ginger Graham and Keith Flaherty, M.D. Ginger Graham is the President and CEO of Two Trees Consulting, where she coaches first-time CEOs of public and private companies. For the last four years, she has been a senior lecturer at Harvard University and a faculty member in its Entrepreneurship Unit. Keith Flaherty, M.D. is an Associate Professor of Medicine at Harvard Medical School, Associate Physician of Medicine, Hematology/Oncology at Massachusetts General Hospital, and Director of the Henri and Belinda Termeer Center for Targeted Therapy, Massachusetts General Hospital Cancer Center. Dr. Flaherty is also the Deputy Chair for Biomarker Sciences and the Chair of the Developmental Therapeutics Committee in the Eastern Cooperative Oncology Group.

Clovis Oncology announced initial findings from the Phase I portion of its ongoing Phase I/II clinical study of CO-1686, the company's novel, oral, targeted covalent (irreversible) inhibitor of mutant forms of the epidermal growth factor receptor (EGFR) for the treatment of non-small cell lung cancer (NSCLC) in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M. Initial results from the Phase I dose-escalation portion of this Phase I/II study are being presented for the first time on Tuesday, June 4 at a poster session during the American Society of Clinical Oncology (ASCO) Annual Meeting 2013 in Chicago. Four RECIST partial responses in T790M positive patients have been observed to date, and the maximum tolerated dose (MTD) has not yet been reached. The Phase I dose escalation portion of the study is being conducted in the United States and France in patients with metastatic or unresectable recurrent NSCLC and a documented EGFR mutation. Patients were not required to be T790M positive for the Phase I portion of the study but had to have progressed on prior EGFR-directed tyrosine kinase inhibitor (TKI) therapy (prior chemotherapy was also allowed). Study objectives were typical for a Phase I trial: determining safety and tolerability, evaluating the pharmacokinetic profile, maximum tolerated dose (MTD) and recommended Phase II dose (RP2D), as well as identification of preliminary efficacy signals. Forty-two patients have been treated with CO-1686 as of May 2013, mostly in once-daily (QD) and twice-daily (BID) dosing cohorts up to 900mg QD and 900mg BID. Dose-escalation will continue with an improved formulation in the third quarter as the MTD has not yet been reached. Objective responses have been observed in heavily pretreated T790M+ patients who are resistant to erlotinib. Additionally, metastasis shrinkage has been observed at multiple organ sites, including both brain and liver metastases.

Clovis Oncology, Inc. will be added to NASDAQ Biotechnology Index.