ArQule Announces Data Presentations with Tivantinib to Be Featured at ASCO 2014
Company Also Provides Update on Phase 3 Trial in Hepatocellular Carcinoma
The presentations will feature tivantinib in clinical trials across multiple diseases and therapeutic combinations. Data will relate to the safety and combinability of tivantinib with approved anti-cancer agents, supporting the ongoing development of this compound.
The most advanced ongoing clinical trial with tivantinib is a pivotal Phase 3 randomized, double-blind controlled study (the METIV-HCC trial) of the compound as single agent therapy in previously treated patients with MET-diagnostic-high, inoperable hepatocellular carcinoma (HCC).
"Enrollment in the METIV-HCC trial continues to gather momentum, with
the Data Monitoring Committee having completed its most recent meeting,"
Logistical information for the ASCO presentations featuring tivantinib follows below.
ONC-2012-001: A single-arm phase II study of tivantinib (ARQ 197) plus cetuximab in EGFR inhibitor-resistant MET high patients (pts) with locally advanced or metastatic colorectal cancer (CRC) with wild-type KRAS.
S Hall A2, Poster Board: #117B
Tivantinib plus erlotinib versus placebo plus erlotinib in Asian patients with previously treated nonsquamous NSCLC with wild-type EGFR: First report of a phase III ATTENTION trial.
S Hall A2, Poster Board #225
Phase II study of erlotinib plus tivantinib in patients with EGFR-mutation-positive NSCLC who failed in immediately previous EGFR-TKI therapy.
S Hall A2, Poster Board: #233
Phase I-Ib trial of tivantinib in combination with carboplatin and pemetrexed as first-line treatment in patients (pts) with advanced nonsquamous NSCLC or malignant pleural mesothelioma (MPM).
S Hall A2, Poster Board #217A
A phase II study of tivantinib (ARQ-197) for metastatic triple-negative breast cancer.
S Hall A2, Poster Board #199
A phase I study of ARQ 197 in combination with temsirolimus in patients (Pts) with advanced solid tumors.
S Hall A2, Poster Board #18
A phase 1 study of the c-Met inhibitor tivantinib (ARQ 197, IND#112603) in children with relapsed or refractory solid tumors: A Children's
S Hall A2, Poster Board #90
This press release contains forward-looking statements regarding
clinical trials with tivantinib, information about which is being
presented at the 2014 ASCO Annual Meeting. These statements are
based on the Company's current beliefs and expectations, and are subject
to risks and uncertainties that could cause actual results to differ
materially. There can be no assurance that tivantinib alone or in
a combination therapy will demonstrate promising therapeutic effects in
pivotal or other trials; in addition, tivantinib may ultimately not
demonstrate an appropriate safety profile in later stage or larger scale
clinical trials, such as the Phase 3 METIV-HCC trial in hepatocellular
carcinoma, including among patients with underlying cirrhosis and
compromised liver function, as a result of known or as yet unanticipated
side effects. The results achieved in later stage trials may not be
sufficient to meet applicable regulatory standards or to justify further
development. Problems or delays may arise during clinical trials or in
the course of developing, testing or manufacturing tivantinib that could
lead the Company or its partners Daiichi Sankyo and Kyowa Hakko Kirin to
discontinue development. Even if later stage clinical trials are
successful, unexpected concerns may arise from analyses of data or from
additional data. Obstacles may arise or issues may be identified in
connection with review of clinical data with regulatory authorities, and
regulatory authorities may disagree with the Company's view of the data
or require additional data or information or additional studies. In
addition, the planned timing of completion of clinical trials like
METIV-HCC is subject to the ability of the Company or its partners to
enroll patients, enter into agreements with clinical trial sites and
investigators, and overcome ongoing or emergent regulatory issues and
address other technical hurdles and issues related to the conduct of the
trials for which each of them is responsible that may not be resolved
promptly, or at all. Drug development involves a high degree of
risk. Only a small number of research and development programs result in
the commercialization of a product. Furthermore,
1Future Oncol. (2014) 10(2), 285-304 and
VP, Investor Relations/Corp. Communications
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