Clovis Oncology (CLVS) announced the commencement of dosing in an early-stage study (TIGER2: n~125) to evaluate its pipeline candidate CO-1686. Clovis Oncology is developing CO-1686 as a monotherapy for the treatment of patients suffering from second-line epidermal growth factor receptor (:EGFR) mutant non-small cell lung cancer (:NSCLC) with T790M mutation. The primary objective of the study is to assess the overall response rate. Parameters like duration of response, progression-free survival, overall survival and safety are the key secondary endpoints of the study.
CO-1686 has performed encouragingly in studies so far and the company intends to seek U.S. approval of the candidate for the above indication by mid 2015. Clovis Oncology will seek FDA approval on the basis of data from the above registration study. Furthermore, data from two phase II expansion cohorts (enrollment underway) of a phase I/II study on CO-1686 will also form the basis of the new drug application submission.
We remind investors that the FDA awarded breakthrough therapy designation to CO-1686 last month for the NSCLC indication. The designation helps to speed up the development and review process for candidates targeting serious and life-threatening diseases. A candidate enjoying the above designation could benefit from features like the FDA’s fast track development program.
We note that Clovis Oncology’s TIGER program includes two more registration studies apart from TIGER 2. The phase II portion of the TIGER1 study will commence soon. The TIGER 1 study is comparing CO-1686 to Roche’s (RHHBY) Tarceva in newly diagnosed EGFR mutant patients. The TIGER3 study will commence in the latter half of the year.
The company stated that NSCLC accounts for almost 85% of all lung cancer cases. Lung cancer is the most common cancer form in the world with 1.7 million new cases diagnosed annually, according to the company’s press release. We believe investor focus will remain on the development of CO-1686 for NSCLC going forward.
Clovis Oncology carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector are Regeneron Pharmaceuticals (REGN) and Allergan (AGN). Both the stocks sport a Zacks Rank #1 (Strong Buy).