2012-10-02 17:36:58 -
By Jake King
Shares of ArQule (NASDAQ:ARQL) are being crushed in early trading on Tuesday
following an announcement that ArQule and partner Daiichi Sankyo (OTC:DSNKY)
will be discontinuing a Phase III non small-cell lung cancer (NSCLC) study of
its lead product tivantinib. After a planned interim analysis of the MARQUEE
trial, an independent safety monitoring committee advised that the drug would
not meet its primary endpoint of improved overall survival in the 1,000 patient
study, and the study should be discontinued. Tuesday's press release stated that
the companies will continue to develop tivantinib for other oncology
indications.
Most frustrating for ArQule shareholders is that their greatest fear, safety
issues, were not the cause of the discontinuation, but rather efficacy. In
August, enrollment for a separate, Asia-based Phase III trial (titled ATTENTION)
of tivantinib
for the same indication was suspended due to safety issues. A data
safety monitoring committee raised concerns when the trial showed higher rates
of interstitial lung disease (ILD). Analysts maintained that the concerns were
unlikely to affect the drug and pointed to the domestic trial as the real
determinant. At the time, PropThink advised against involvement in ARQL until
safety issues were resolved.
The MARQUEE trial pitted tivantinib, which is a c-MET inhibitor, plus erlotinib
against erlotinib plus placebo in previously-treated NSCLC patients. Marketed by
Genentech, a subsidiary of Roche Holdings (OTC:RHHBY), and Astellas Pharma
(OTC:ALPMY) as Tarceva in the U.S., erlotinib is a mainline treatment for NSCLC
and is a tyrosine kinase inhibitor. Interestingly, MARQUEE's interim analysis
did report a significant improvement in progression-free survival, but that data
did not carry into overall survival. Tivantinib's near-term prospects now fall
to a planned Phase III trial for the drug in hepatocellular carcinoma (HCC) and
results from a Phase II trial for colorectal cancer, both due by early 2013.
Already the drug showed promise in a Phase II trial for HCC, so many are pinning
hopes on that indication, as well as the lack of safety issues in Western
tivantinib trials. Shares of ARQL are off 55% to $2.20 in the late morning.
See this article in its original format by clicking here.
About PropThink
PropThink is an intelligence service that delivers long and short trading ideas
to investors in the healthcare and life sciences sectors. Our focus is on
identifying and analyzing technically-complicated companies and equities that
are grossly over or under-valued. We offer daily market coverage, weekly feature
stories, and a newsletter to investors who subscribe on PropThink.com. To learn
more, follow us on Twitter or visit us at
www.propthink.com.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: PropThink via Thomson Reuters ONE
[HUG#1645869]
