Arqule and daiichi sankyo today announced that the independent data monitoring committee dmc has determined that the metivhcc will continue to its final analysis metivhcc is a biomarkerselected, doubleblind, placebocontrolled, pivotal phase iii study evaluating tivantinib 2. Arqules tivantinib study results disappoint marketwatch. To said a study showed the combined use of tivantinib with two other cancerfighting treatments didnt meet the. Initiating free research reports on arqule and three other. Arqule announces topline results of phase 3 clinical. Arqule presents preclinical data for btk inhibitor, arq 531, at the 22 nd annual congress of the european hematology association eha. Tivantinib arq 197 versus placebo in patients pts with hepatocellular carcinoma hcc who failed one systemic therapy. Celldex presents data from cdx3379 study at asco, stock down. Arqule and daiichi sankyo announce completion of patient.
Preclinical and phase 1 data suggested a possible role for met in the pathophysiology of germ cell tumors gcts and a potential clinical benefit from tivantinib in patients with these tumors. Investor protection, diversi cation, investment, and tobins q yingcong lany neng wangz jinqiang yangx september 19, 2012 abstract we develop a dynamic incompletemarkets model where an entrenched insider, facing imperfect investor protection and nondiversi able illiquid business risk, makes interdepen. The calculated inhibitory constant ki for tivantinib to inhibit recombinant human cmet was approximately 355 nmoll. Arql today is presenting preliminary results from the companys phase 1 dose escalation study for arq 531, an orally bioavailable, potent and reversible inhibitor of both. Tivantinib tivantinib hcc arq 092 arq 087 arq 761 target indications preclinical phase 1b2. Article daiichi sankyo launches flu drug inavir inhaler in japan.
Arqule jefferies global healthcare conference june 2015. Tse 4568 today announced that recruitment of patients has been completed in the randomized, doubleblind, controlled phase 3 marquee pivotal trial of their investigational selective cmet inhibitor, tivantinib, in combination with erlotinib in previously treated patients with locally advanced or metastatic, nonsquamous, nonsmall. Arq 531 is an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and c481smutant brutons tyrosine. Upcoming events allergan looks to vitae and arqule. Arqule presents preliminary clinical data for arq 087. Now the full results from this trial will be presented at the 2012 annual meeting of american society of clinical oncology, including. This phase 3 study in met diagnostichigh inoperable hcc subjects has been designed based on the results from the randomized, controlled phase 2 study conducted by arqule, inc. Kyowa hakko kirin signed a license agreement with arqule for the. Hepatocellular carcinoma hcc is the fifth most common malignancy worldwide. Sirtex medical, abbvie, and arqule and nonfinancial support from arqule and ipsen, outside the submitted work. Arql today announced that preclinical data for arq 531 in diffuse large bcell lymphoma dlbcl in vitro and in vivo tumor models was presented at eha congress in madrid, spain. At diagnosis, more than 80% of patients with hepatocellular carcinoma present with multicentric tumours and concurrent liver cirrhosis.
Background tivantinib is a selective, smallmolecule inhibitor of the met receptor tyrosine kinase. Propthink is a newsletter service that delivers long and short trading ideas to investor in the healthcare and life sciences sectors. All 21 patients eventually discontinued the treatment, 17. Positive phase 2 clinical data with tivantinib in hepatocellular carcinoma to be highlighted in oral presentation at 2012 annual meeting of american society of clinical oncology. Possible applications include nonsmallcell lung carcinoma, hepatocellular carcinoma, and oesophageal. Daiichi sankyo and arqule announce the completion of the metivhcc phase 3 study of tivantinib in secondline treatment of metoverexpressing hepatocellular carcinoma arqule to host investor conference call on february 17, 2017 at 8. Daiichi sankyo and arqule announce the completion of the metiv hcc phase 3 study of tivantinib in secondline treatment of metoverexpressing hepatocellular carcinoma arqule to host investor conference call on february 17, 2017 at 8. When a family of color successfully navigates the complicated application and testing process and enrolls in hcc, their child may be the only child of color in their class.
Arql today announced that the first patient has been enrolled in the pivotal phase 3 metiv hcc methigh patients with tivantinib in hcc trial of tivantinib arq. Carcinoma patient into global phase 3 trial for tivantinib tokyo, japan and woburn, ma january 31, 20 daiichi sankyo company, limited tse 4568 and arqule, inc. A candidate drug for colorectal cancer in development at daiichi sankyo and arqule has failed to meet its primary endpoint in a phase ii trial. Planned interim analysis expected to occur early in the second quarter of 2016. Based on these results, tivantinib has been evaluated in two phase iii trials in patients. Arqule presents preclinical data for btk inhibitor, arq.
Arqule and daiichi sankyo drop tivantinib trial in nsclc. Investor protection, diversi cation, investment, and tobins q. Arqule to host investor conference call on february 17, 2017 at 8. Arql today reported that its partner, kyowa hakko kirin, announced topline results of the jethcc phase 3. Arqules cmet inhibitor tivantinib has failed yet another latestage trial. Connect with aco leaders at the naacos spring conference, april 2527, 2018. Regorafenib for the treatment of unresectable hepatocellular. Tivantinib failed to improve overall survival compared with placebo as a secondline therapy for patients with metoverexpressing inoperable. Hence, we expect investor focus on futher updates on the phase iii results.
Dont miss the opportunity to inform and network with aco leaders from across the country at the naacos spring conference at the hilton. Arqule announces tivantinib meets primary endpoint. Arqule currently does not have any marketed product in its portfolio and tivantinib is its most advanced stage candidate. Arqule arql provides results from ongoing phase 1 dose. Cldx free report presented data from the phase ii study on cdx3379 at the annual meeting of the american society of clinical oncology asco. Arqule meanwhile could be due for a big jump in valuation should the phase iii metivhcc trial of tivantinib in liver cancer return positive data. Tivantinib failed to improve overall survival compared with placebo as a secondline therapy for patients with metoverexpressing inoperable hepatocellular carcinoma in the phase iii metiv hcc study. Phase iii tivantinib study in hepatocellular carcinoma. It is a bisindolylmaleimide that binds to the dephosphorylated met kinase in vitro. Arql today reported that its partner, kyowa hakko kirin, announced topline results of the jethcc phase 3 trial of tivantinib. The hepatocellular carcinoma hcc treatment landscape changed a decade ago, with sorafenib demonstrating survival benefit in the firstline setting and becoming the first systemic therapy to be. Arqule presents clinical biomarker data from phase 2 study.
The earlystage trial, which is still ongoing, looks at. Tse 4568 today 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 secondline treatment in hepatocellular carcinoma hcc. Arqule announces tivantinib meets primary endpoint, significantly extending time to progression in phase 2 trial in secondline hepatocellular carcinoma woburn, mass. More convenient proteasome inhibition for improved outcomes.
Cldx institutional ownership celldex therapeutics, inc. Tivantinib arq 197 is an oral, nonadenosine triphosphatecompetitive, selective, smallmolecule met protooncogene cmet inhibitor. Tivantinib arquledaiichi sankyokyowa hakko kirin is an orally available small molecule inhibitor of the hepatocyte growth factor hgf receptor, cmet. However, the mechanism of action of tivantinib is still unclear. Kyowa hakko kirin announces discontinuation for developing arq. Arqule and daiichi sankyo announce completion of accrual. Tivantinib achieves advantage for patients with hcc. Additional randomised studies are needed to establish whether.
Profile of tivantinib and its potential in the treatment. On december 11, 2018, we entered into a clinical supply agreement with a whollyowned subsidiary of astrazeneca plc, or astrazeneca, to evaluate the safety and efficacy of astrazenecas imfinzi durvalumab, a human monoclonal antibody directed against programmed deathligand 1, or pdl1, in. Arql shares tumbled nearly 20% this morning after investors learned that the companys metiv hcc phase 3 study of tivantinib in hepatocellular carcinoma hcc did not meet. Arqule stock rockets 49% toward 12year high after biotech announces phase 1 trial results. Please see below for the transfer agent contact information. Naacos spring 2018 conference sponsor and exhibitor prospectus. Arqule is a research client of edison investment research limited 20 will be a year in which arqule and its partners are focused on progressing andor completing clinical trials with tivantinib, but one which sees relatively few new clinical data readouts.
The first study of tivantinib monotherapy in patients with hcc was a phase ib study conducted by santoro et al. Liver cancer miss adds to litany of trial failures for arqules tivantinib. This is the only project in the massachusetts groups pipeline with any significant forecasts, so it needs good news to gain investor interest. Racial equity in alhc help improve racial equity in. The arqule investor conference call can be accessed in the investors and media section of arqule s website. Daiichi sankyo and arqule announce the completion of the metiv. Tokyo, japan and woburn, ma january 11, 20 daiichi sankyo company, limited tse 4568 and arqule, inc.
Arqules lead product, in phase 3 clinical development, is tivantinib arq 197, an oral, selective inhibitor of the cmet receptor tyrosine kinase, for secondline treatment of hepatocellular. Tivantinib for secondline treatment of methigh, advanced. Daiichi sankyo and arqule announce the completion of the. Arql today announced the topline results of a randomized phase 2 signal generation trial of tivantinib arq 197 used in combination with irinotecan and cetuximab in patients with refractory or relapsed colorectal cancer. Article kyowa hakko kirin starts ph iii trial of arq 197 tivantinib in nsclc patients in asia. Tivantinib arq 197 versus placebo in patients pts with. Tivantinib has demonstrated statistically significant improvements in time to progression and overall survival versus placebo among patients with unresectable hepatocellular carcinoma. The drug, called tivantinib arq 197, was unable to meet the target of prolonging progressionfree survival pfs in patients during the course of the study, which involved individuals with refractory. Profile of tivantinib and its potential in the treatment of hepatocellular. Tivantinib is being tested clinically as a highly selective met inhibitor. The arqule investor conference call can be accessed in the investors and media section of arqules website. Burlington, ma, tokyo, japan, munich, germany and parsippany, nj february 17, 2017. Tivantinib did not improve overall survival compared with placebo in patients with methigh advanced hepatocellular carcinoma previously treated with sorafenib. Arqule shares jump on positive phase ii liver cancer data.
Arql today announced that an analysis of preliminary baseline tumor met status of patients screened in the phase 3 metivhcc trial for tivantinib in secondline hepatocellular carcinoma hcc confirms previously presented data from the companys phase 2 trial in the. The speed of patient accrual in the recently opened metiv. Pdf systemic therapy for intermediate and advanced. Although this metiv hcc trial was negative, the study shows the feasibility of doing integral tissue biomarker studies in patients with advanced hepatocellular carcinoma. Burlington, massachusetts headquartered arqule inc. Article daiichi sankyo to license arq 092 from arqule, under joint akip research collaboration. A white student in sps is 16 times more likely to be offered admission to the hcc program, and 6 times more likely than a latino student. In addition, the planned interim analysis, which is. Daiichi, arqule cancer drug tivantinib flunks another.
Arq 531 is an orally bioavailable, potent and reversible inhibitor of both wild type and c481smutant brutons tyrosine. Aberrant expression of hgfcmet promotes angiogenesis, cancer cell proliferation, and metastasis via growth factor receptors and other oncogenic pathways, and has been observed in many. Phase i study of tivantinib in japanese patients with advanced. Arql today announced clinical data from the companysponsored arq 531101 phase 1 dose escalation study in subjects with relapsed or refractory hematologic malignancies will be presented on june 15, 2018 at the eha congress in stockholm, sweden.
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