Biotechnology company Exelixis Inc. (EXEL) is expected to have some path-breaking information related to the treatment of cancer when it presents data from trials of three late-stage compounds at the American Society of Clinical Oncology, or ASCO, annual meeting, later this week.
The South San Francisco, California-based company is engaged in the discovery, development and commercialization of small molecule drugs for the treatment of cancer, metabolic, and cardiovascular disorders. It has 14 compounds in clinical development, including those developed by its partners.
Of these most advanced are XL184, XL147 and XL765, which are the focus of 15 individual trials investigating that many number of unique tumor types. They have significant commercial potential as both single agent and combination treatment modalities.
George Scangos, president and chief executive officer of Exelixis, said recently, "We're very encouraged by the data emerging from our late-stage clinical compounds, XL184, XL147 and XL765. They each have demonstrated important signs of clinical activity and are currently in broad development programs in indications where we think they can have the greatest impact for patients and maximize their commercial potential. We look forward to presenting a substantive body of data on these compounds at ASCO in June."
XL184, co-developed with Bristol-Myers Squibb (BMY), is an investigational drug that inhibits VEGFR2, MET and RET, kinases that are involved in tumor formation, growth and migration. It is being evaluated in a late-stage trial as a single-agent therapy in patients with unresectable, locally advanced, or metastatic medullary thyroid cancer.
The phase III trial of XL184 in medullary thyroid cancer was initiated in June 2008 via the Special Protocol Assessment process based on the impressive data of phase I trial presented at 2008 ASCO annual meting. In the phase I trial, XL184 achieved greater than 50% response rate and 100% disease control rate in patients with medullary thyroid cancer.
In the phase III study of XL184 in medullary thyroid cancer , the experimental drug is being compared with placebo, where the subjects would be randomized to receive XL184 or placebo in a 2:1 ratio. The estimated final data collection date for primary outcome measure is in June, with the study estimated to be completed in March 2013.
The compound is also under various stages of study for certain other indications. It is being tested in a phase II study in patients with progressive or recurrent glioblastoma multiforme, or GB, a form of brain tumor, in first or second relapse.
The study is evaluating the safety, tolerability, and clinical activity of XL184 at continuous daily doses of 175 mg or 125 mg in patients with previously treated GB. It includes two populations of patients who either did or did not receive prior therapy with an antiangiogenic agent. As of May 19, 195 patients in first or second relapse have been enrolled in three successive cohorts.
The compound is also under a phase 1b/2 trial with erlotinib in non-small cell lung cancer patients who have progressed after prior benefit from erlotinib and is also in a phase 1 trial in patients with advanced malignancies.
At the ASCO meeting in June, out of the 12 presentations Exelixis is making, four will be on XL184 alone.
The company will make an oral presentation of the data from the XL184-201 trial, currently evaluating the 125 milligram daily dose of XL184 in patients with recurrent glioblastoma. Exelixis said recently that substantial activity of XL184 in patients with recurrent glioblastoma was observed, with 82% of the overall trial population and 91% of the antiangiogenic therapy naïve population and at least one post-baseline MRI scan experiencing tumor reduction.
There will also be a poster presentation with the first data from the randomized discontinuation trial evaluating XL184 in melanoma, small cell and non-small cell lung, gastric and GE junction, breast, ovarian, pancreatic, prostate, and hepatocellular cancers.
The third will be a poster presentation covering the preliminary data of XL184 in combination with Erlotinib in non-small cell lung cancer. The last presentation will be an oral presentation of the long-term follow up from the company's initial Phase I trial of XL184 in patients with medullary thyroid cancer.
The other two late-stage compounds, XL147 and XL765, are inhibitors of phosphatidylinositol 3-kinases, or PI3K. Upregulation of PI3K activity is a common characteristic of tumor cells, and inhibition of PI3K is expected to have great potential in cancer treatment. PI3K inhibitors are touted as drugs of the future.
XL147, co-developed with Sanofi-Aventis (SNY), is under a phase 1b/2 trial in combination with erlotinib in non-small cell lung cancer patients, and is also being evaluated in a phase 1b/2 trial in combination with paclitaxel/carboplatin in patients with solid tumors. The compound is also under a phase 1 trial in patients with solid tumors.
XL765, also co-developed with Sanofi-Aventis (SNY), is under a phase 1b/2 trial with temozolomide in glioblastoma patients, and is being evaluated in a phase 1b/2 trial with erlotinib in non-small cell lung cancer patients, in addition to a phase 1 trial in patients with solid tumors.
The company will make six presentations on XL147 and XL765 at the ASCO, highlighting the early experience with these compounds in single agents and in various combination studies. Exelixis is expected to provide an in-depth update on up-to-the-minute datasets for XL184, XL147, and XL765 at their individual ASCO presentations.
The other investigational drugs in the company's pipeline include XL518, XL228, XL139, XL413, and XL888, which are under phase I development. The company has also out-licensed several compounds to third parties for further development and commercialization. The presentations at the ASCO will also cover XL228 and XL139.
Exelixis said in a conference call recently that it is in advanced discussions with many companies about several of its compounds and is confident that one or more of these discussions will result in partnerships this year.
In March, the company announced a restructuring program with a view to aligning its resources with its late-stage compounds. The move, which includes a 40% reduction in workforce, is expected to increase the company's financial strength.
In the first quarter of 2010, Exelixis reported a net loss of $43.25 million or $0.40 per share. Revenues for the quarter were $42.2 million, up nearly 67% from last year, due primarily to revenue from XL147, XL765 and discovery PI3K collaborations with Sanofi-Aventis, and increased revenue from collaboration with Roche's Genentech on XL518.
EXEL closed Tuesday's regular trade at $4.89, down from the prior close of $5.18, on 947,500 shares. For the past year, the stock traded in the range of $4.25-$8.00.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.