) and partner Daiichi Sankyo recently announced that former has
enrolled the first patient for the phase III METIV-HCC (MET-high
patients with tivantinib in HCC) trial of their oncology
candidate tivantinib (ARQ 197).
The study, which will be conducted on over 300 patients at
over 120 centers globally, will evaluate trivantinib for the
treatment of patients suffering from hepatocellular carcinoma
(HCC) who have previously received one or two prior systemic
The primary endpoint of the trial is overall survival (OS)
while the secondary endpoint is progression-free survival
We note that ArQule reached a Special Protocol Assessment
(SPA) agreement with the US Food and Drug Administration (FDA)
for the phase III trial of tivantinib in patients with HCC in Oct
ArQule will receive a $15 million milestone payment from
Daiichi Sankyo as per its license agreement. We note that ArQule
and Daiichi Sankyo signed a license, co-development and
co-commercialization agreement in Dec 2008 for tivantinib. The
agreement covers US, Europe, South America and the rest of the
world but excludes Japan, China (including Hong Kong), South
Korea and Taiwan.
We remind investors that ArQule suffered a setback last month
when it announced disappointing phase II results on tivantinib
which was being evaluated as a combination therapy in patients
with refractory or relapsed colorectal cancer (CRC).
The study failed to meet its key endpoint of progression-free
survival (PFS); median PFS was 8.3 months in the tivantinib arm
compared with 7.3 months in the control arm (irinotecan and
cetuximab plus placebo). The secondary endpoint of objective
response rate (ORR) was also not statistically significant
compared to the control arm (45% versus 33%).
ArQule currently carries a Zacks Rank #3 (Hold). Pharma stocks
that currently look attractive are
Salix Pharmaceuticals Ltd
United Therapeutics Corporation
) with a Zacks Rank #1 (Strong Buy).
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