Cell Signaling Technology (CST) granted Pfizer a worldwide, nonexclusive license under the patent estates pooled by CST and Astellas Pharma relating to EML4 anaplastic lymphoma kinase (ALK). The fusion kinase EML4-ALK has been found to be present in a subset of patients with non-small-cell lung cancer (NSCLC).
CST discovered the abnormal gene rearrangement EML4-ALK in NSCLC. The presence of the ALK fusion gene in lung cancer was also reported by a Japanese researcher in 2007.
Pfizer and Abbott entered into a separate agreement in August 2009 to develop and commercialize a companion diagnostic test to screen NSCLC tumors for the presence of rearrangements in the ALK gene. Pfizer will grant a sublicense to Abbott under the patent estates from CST and Astellas.
Abbott will work on developing diagnostic products based on fluorescence in situ hybridization (FISH) technology for ALK detection. Detection of ALK-positive NSCLC is necessary for selection of patients for treatment with Pfizer’s Phase III crizotinib (previously known as PF-02341066), an oral class agent that inhibits ALK.
Since 2009, Pfizer has canned three NSCLC trials. In December 2009, the firm stopped a Phase III study evaluating figitumumab added to paclitaxel and carboplatin in patients with advanced nonadenocarcinoma NSCLC. About three months later, it halted a late-stage evaluation of figitumumab as a second/third-line treatment for the same indication. The mAb targeted the insulin-like growth factor-1 receptor.
In August 2010, Pfizer reported that a Phase III advanced NSCLC trial with Sutent in combination with erlotinib did not meet its primary endpoint of overall survival. Sutent, an oral multikinase inhibitor, is currently approved for advanced metastatic renal cell carcinoma and gastrointestinal stromal tumors after disease progression on or intolerance to imatinib mesylate.