ArQule to present tivantinib clinical trial data at ASCO 2014

ArQule, Inc. (Nasdaq: ARQL) today announced that tivantinib will be included in seven presentations during the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held from May 30, 2014 to June 3, 2014 in Chicago, Illinois.

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," said Paolo Pucci, chief executive officer of ArQule. "We believe that recruitment figures reflect our investigators' enthusiasm, which has been further enhanced by recent publications1 that underscore the potential of MET as a target of interest in HCC," said Mr. Pucci.

Logistical information for the ASCO presentations featuring tivantinib follows below.

Abstract #TPS3661
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.

Saturday, May 31, 2014, 8:00 AM to 11:45 AM
S Hall A2, Poster Board: #117B
Lorenza Rimassa, MD

Abstract #8044
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.

Saturday, May 31, 2014, 1:15 PM to 5:00 PM
S Hall A2, Poster Board #225
Koichi Azuma, MD, PhD

Abstract #8052
Phase II study of erlotinib plus tivantinib in patients with EGFR-mutation-positive NSCLC who failed in immediately previous EGFR-TKI therapy.

Saturday, May 31, 2014, 1:15 PM to 5:00 PM
S Hall A2, Poster Board: #233
Tomonori Hirashima, MD

Abstract #TPS7610
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).

Saturday, May 31, 2014, 1:15 PM to 5:00 PM
S Hall A2, Poster Board #217A
Paolo A. Zucali, MD

Abstract #1106
A phase II study of tivantinib (ARQ-197) for metastatic triple-negative breast cancer.

Monday, June 2, 2014, 8:00 AM to 11:45 AM
S Hall A2, Poster Board #199
Sara M. Tolaney, MD, MPH

Abstract #2555
A phase I study of ARQ 197 in combination with temsirolimus in patients (Pts) with advanced solid tumors.

Sunday, June 1, 2014, 8:00 AM to 11:45 AM
S Hall A2, Poster Board #18
Amy M. Braden, DO

Abstract #2627
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 Oncology Group study.

Sunday, June 1, 2014, 8:00 AM to 11:45 AM
S Hall A2, Poster Board #90
James I. Geller, MD

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