) 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
) 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
). Both the stocks sport a Zacks Rank #1 (Strong Buy).
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