ArQule (ARQL), Daiichi Sankyo Say Tivantinib Phase 2 Met Primary Endpoint; to Present Data at ASCO
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ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo, Co., Ltd. announced that an oral presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) will feature Phase 2 trial data with tivantinib as a single agent investigational second-line treatment in hepatocellular carcinoma (HCC). ArQule announced that this randomized, double-blind study met its primary endpoint in January and will now present the full results from this trial, including positive data in the pre-defined c-MET high population. Additional clinical data with tivantinib will be featured in two poster discussions and two general poster sessions.
From the release:
HCC Trial Summary: c-MET high patients
Data from the HCC trial demonstrated a statistically significant improvement in time-to-progression (HR=0.43, log rank p-value=0.03), accompanied by significant improvements in progression-free survival and disease control rate among second-line patients with c-MET high tumors who were treated with tivantinib. In addition, overall survival data were observed favoring tivantinib-treated patients in this population. Efficacy was similar in the two tivantinib dosing subgroups (360 milligrams twice daily and 240 milligrams twice daily), with less frequent neutropenia in the lower dose.
Previously announced top-line data from the HCC trial demonstrate that treatment with tivantinib produced a statistically significant 56 percent improvement in TTP in the intent-to-treat (ITT) population by central radiology review, the primary endpoint (HR = 0.64, log rank p-value = 0.04) in this trial. Adverse events were reported at similar rates in the treatment and placebo arms, except for a higher incidence of fatigue and hematologic events, including neutropenia and anemia, in tivantinib-treated patients. The incidence of hematologic events declined following dose reduction of tivantinib from 360 milligrams twice daily to 240 milligrams twice daily.
The schedule of this and other presentations of data with tivantinib is provided below. All times are Central Daylight Time.
Oral Presentation
Date and time: Saturday, June 2, 2012, 5:00 PM – 5:15 PMAbstract number: 4006Poster title: Tivantinib (ARQ 197) versus placebo in patients (Pts) with hepatocellular carcinoma (HCC) who failed one systemic therapy: Results of a randomized controlled phase II trial (RCT)Presenter: Lorenza Rimassa, MDLocation: E Hall D1
Poster Discussion Sessions
Date and time: Saturday, June 2, 2012, 8:00 AM – 12:00 PMAbstract number: 4545Poster title: Safety and efficacy of MET inhibitor tivantinib (ARQ 197) combined with sorafenib in patients (pts) with renal cell carcinoma (RCC) from a phase 1 studyPoster board # 24Presenter: Igor Puzanov, MDLocation: E450a
Date and time: Saturday, June 2, 2012, 1:15 PM – 5:15 PMAbstract number: 8519Poster title: Safety and efficacy of MET inhibitor tivantinib (ARQ 197) combined with sorafenib in patients (pts) with NRAS wild-type or mutant melanoma from a phase 1 studyPoster board # 8Presenter: Julie A. Means-Powell, MDLocation: E450b
General Poster Session
Date and time: Monday, June 4, 2012, 8:00 AM – 12:00 PMAbstract number: 4117Poster title: Safety and efficacy of MET inhibitor tivantinib (ARQ 197) combined with sorafenib in patients (pts) with hepatocellular carcinoma (HCC) from a phase 1 studyPoster board # 50DPresenter: Robert E. Martell, MD, PhDLocation: S Hall A2
Date and time: Monday, June 4, 2012, 8:00 AM – 12:00 PMAbstract number: 4082Poster title: A phase II study of tivantinib monotherapy in patients with previously treated advanced or recurrent gastric cancerPoster board # 46APresenter: Kei Muro, MDLocation: S Hall A2
Tivantinib is currently in Phase 3 development and has not yet been approved for any indication.
From the release:
HCC Trial Summary: c-MET high patients
Data from the HCC trial demonstrated a statistically significant improvement in time-to-progression (HR=0.43, log rank p-value=0.03), accompanied by significant improvements in progression-free survival and disease control rate among second-line patients with c-MET high tumors who were treated with tivantinib. In addition, overall survival data were observed favoring tivantinib-treated patients in this population. Efficacy was similar in the two tivantinib dosing subgroups (360 milligrams twice daily and 240 milligrams twice daily), with less frequent neutropenia in the lower dose.
Previously announced top-line data from the HCC trial demonstrate that treatment with tivantinib produced a statistically significant 56 percent improvement in TTP in the intent-to-treat (ITT) population by central radiology review, the primary endpoint (HR = 0.64, log rank p-value = 0.04) in this trial. Adverse events were reported at similar rates in the treatment and placebo arms, except for a higher incidence of fatigue and hematologic events, including neutropenia and anemia, in tivantinib-treated patients. The incidence of hematologic events declined following dose reduction of tivantinib from 360 milligrams twice daily to 240 milligrams twice daily.
The schedule of this and other presentations of data with tivantinib is provided below. All times are Central Daylight Time.
Oral Presentation
Date and time: Saturday, June 2, 2012, 5:00 PM – 5:15 PMAbstract number: 4006Poster title: Tivantinib (ARQ 197) versus placebo in patients (Pts) with hepatocellular carcinoma (HCC) who failed one systemic therapy: Results of a randomized controlled phase II trial (RCT)Presenter: Lorenza Rimassa, MDLocation: E Hall D1
Poster Discussion Sessions
Date and time: Saturday, June 2, 2012, 8:00 AM – 12:00 PMAbstract number: 4545Poster title: Safety and efficacy of MET inhibitor tivantinib (ARQ 197) combined with sorafenib in patients (pts) with renal cell carcinoma (RCC) from a phase 1 studyPoster board # 24Presenter: Igor Puzanov, MDLocation: E450a
Date and time: Saturday, June 2, 2012, 1:15 PM – 5:15 PMAbstract number: 8519Poster title: Safety and efficacy of MET inhibitor tivantinib (ARQ 197) combined with sorafenib in patients (pts) with NRAS wild-type or mutant melanoma from a phase 1 studyPoster board # 8Presenter: Julie A. Means-Powell, MDLocation: E450b
General Poster Session
Date and time: Monday, June 4, 2012, 8:00 AM – 12:00 PMAbstract number: 4117Poster title: Safety and efficacy of MET inhibitor tivantinib (ARQ 197) combined with sorafenib in patients (pts) with hepatocellular carcinoma (HCC) from a phase 1 studyPoster board # 50DPresenter: Robert E. Martell, MD, PhDLocation: S Hall A2
Date and time: Monday, June 4, 2012, 8:00 AM – 12:00 PMAbstract number: 4082Poster title: A phase II study of tivantinib monotherapy in patients with previously treated advanced or recurrent gastric cancerPoster board # 46APresenter: Kei Muro, MDLocation: S Hall A2
Tivantinib is currently in Phase 3 development and has not yet been approved for any indication.
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