On December 1, 2014 Exelixis reported top-line results from the final analysis of COMET-2 (NCT01522443), a randomized, double-blind, controlled trial of cabozantinib in men with metastatic castration-resistant prostate cancer (mCRPC) who are suffering from moderate to severe pain despite optimized narcotic medication, and whose disease has progressed following treatment with docetaxel as well as abiraterone and/or enzalutamide (Press release Exelixis, DEC 1, 2014, View Source;p=RssLanding&cat=news&id=1993605 [SID:1234501037]). The trial did not meet its primary endpoint of alleviation of bone pain, as determined by comparing the percentage of patients in the two treatment arms who achieved a pain response at Week 6 that was confirmed at Week 12 without increase in narcotic medication. Fifteen percent of patients in the cabozantinib arm reported a pain response, compared to 17 percent of patients in the control arm receiving mitoxantrone/ prednisone. The difference in pain response between the arms was not statistically significant. The safety profile of cabozantinib in the trial was consistent with that observed in previous studies in mCRPC.

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"Following the COMET-1 top-line results announced in September, we deprioritized the cabozantinib development program in mCRPC; at that time, we also initiated a significant workforce reduction in order to focus our development efforts and financial resources on the pivotal phase 3 studies of cabozantinib in metastatic renal cell carcinoma (RCC) and advanced hepatocellular carcinoma (HCC)," said Michael Morrissey, Ph.D., president and chief executive officer of Exelixis. "With target enrollment in the METEOR study in RCC recently achieved, we anticipate top-line results in the second quarter of 2015. We also look forward to Roche and Genentech’s continued regulatory progress with cobimetinib for metastatic melanoma. The EU review is underway and the U.S. filing is expected before year-end, which could ultimately lead to our opportunity to co-promote cobimetinib in the U.S. if it is approved for this indication."

Exelixis will submit the results from the COMET program for potential presentation at a future medical meeting.

On December 1, 2014 Calithera Biosciences presented the corporte presentation (Presentation, Calithera Biosciences, DEC 1, 2014, View Source [SID1234535306]).

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On December 1, 2014 Calithera Biosciences presented the corporate presentation (Poster, ASH (Free ASH Whitepaper) 2014, Calithera Biosciences, DEC 1, 2014, View Source [SID1234535307]).

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On December 1, 2014 Eisai reported that it has submitted its application to the regulatory authority in South Korea (Ministry of Food and Drug Safety) for marketing approval of its novel in-house developed anticancer agent lenvatinib mesylate (lenvatinib) as a treatment for progressive radioiodine-refractory differentiated thyroid cancer (Press release Eisai, NOV 30, 2014, View Source [SID:1234501033]). Following the submission of marketing authorization applications in Japan, the United States and Europe, this marks the first time Eisai has submitted a marketing authorization application for lenvatinib in Asia.

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Lenvatinib is an oral molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR, involved in angiogenesis and tumor proliferation. This potentially makes lenvatinib a first-in-class treatment in thyroid cancer, especially given that it simultaneously inhibits the activity of the three molecules VEGFR, FGFR and also RET via its novel binding mode.

The application submitted for South Korea was based on the positive results from a global Phase III clinical study known as the SELECT (Study of (E7080) LEnvatinib in differentiated Cancer of the Thyroid) trial. (Please refer to the following notes for further details of the trial)

An application seeking the approval of lenvatinib for the indication of thyroid cancer was submitted in Japan in June 2014 as the first in the world, followed by the submission of applications in both the United States and Europe in August 2014. Lenvatinib was granted Orphan Drug Designation for thyroid cancer in by the regulatory authorities in Japan, Europe and the United States. In addition, lenvatinib was also granted an accelerated assessment in Europe by the European Medicines Agency, and granted priority review status in the United States by the U.S. Food and Drug Administration.

The number of patients newly diagnosed with thyroid cancer in 2012 in South Korea was estimated to be 33,000, and in Asia was estimated to be 144,000. Although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs.

Eisai is committed to exploring the potential clinical benefits of lenvatinib, and is working to obtain marketing approval in each country in Asia as soon as possible in order to further contribute to patients with thyroid cancer, and their families.

On November 28, 2014 AstraZeneca and Cancer Research UK reported that they have signed a memorandum of understanding through which Cancer Research UK drug discovery investigators would be given access to state-of-the-art drug discovery facilities at the new AstraZeneca MRC UK Centre for Lead Discovery to be built in Cambridge (Press release, Cancer Research Technology, NOV 28, 2014, View Source [SID1234523217]).

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As part of the five-year collaboration scientists from Cancer Research UK, through it’s Drug Discovery Units, will benefit from unprecedented access to over two million molecules in AstraZeneca’s compound library and world class screening tools at the facility which will be located within the new AstraZeneca site at the Cambridge Biomedical Campus.

High-throughput screening methods will be used to identify lead compounds within the compound library including fragment-based lead generation, in which small chemical fragments are screened against drug targets; screening of a collection of compounds potentially useful for blocking kinase drug targets, and phenotypic screens to identify active compounds within cells that could be starting points for new drugs.

Cancer Research UK and AstraZeneca screening scientists will work alongside each other on up to five drug screens annually. Cancer Research UK will decide which novel cancer drug discovery projects to investigate and AstraZeneca has the option to negotiate a commercial license with Cancer Research Technology, Cancer Research UK’s commercial arm, to progress the most promising candidates through further drug discovery and development.

Alexa Smith, Cancer Research UK’s Head of Translational Research Funding said: "Having access to AstraZeneca’s extensive compound library and innovative drug discovery technology will help our researchers quickly translate new discoveries into patient benefit. We hope this initial proposed agreement will develop into a longer term arrangement that will boost our drug discovery capabilities further, with scope to develop similar strategic partnerships with other leading drug discovery organisations in future."

Chris Watkins, Director of Translation and Industry at the MRC, said: "It’s fantastic to see the AstraZeneca MRC UK Centre for Lead Discovery attracting another potential innovative collaboration so soon after its inception. Cancer Research UK will bring world-leading expertise in oncology research that fits well with the collaborative spirit of the planned MRC and AstraZeneca partnership and contribute further to building a thriving UK research base and closer engagement between academic and industry scientists."

Menelas Pangalos, Executive Vice President, Innovative Medicines and Early Development, AstraZeneca said: "We’re delighted to build on our strong relationship with Cancer Research UK. This research programme at the AstraZeneca MRC UK Centre for Lead Discovery demonstrates how we will create a truly permeable research environment at our new site in Cambridge. We intend for our scientists to work alongside leading Cancer Research UK scientists, taking advantage of our world-class facilities, to push the boundaries of science and accelerate oncology drug discovery."