|Biomarker Subset||Ficlatuzumab/Gefitinib Combination||Gefitinib Alone|
|# ofSubjects||Median PFS(months)||ORR,%||# ofSubjects||Median PFS(months)||ORR,%|
|EGFR SM+/c-Met Low||10||11.0||70||9||5.5||44|
|EGFR SM+/c-Met High||23||9.2||52||27||9.2||63|
|EGFR SM-/c-Met Low||9||1.3||0||13||2.3||0|
|EGFR SM-/c-Met High||11||1.8||27||16||1.8||13|
“These are important data for driving our ficlatuzumab program forward, as well as for demonstrating the clinical value of AVEO’s proprietary Human Response Platform,” stated William Slichenmyer, M.D., Sc.M., chief medical officer of AVEO. “Through our platform, we were able to recognize the interplay between the EGFR and HGF/c-Met pathways. These biomarker insights, combined with the clinical data, support our continued development of ficlatuzumab in combination with an EGFR inhibitor. We look forward to further clinical investigation in lung cancer. In addition, we will be initiating a clinical study in head and neck cancer later this year.”Study Overview The open-label, two-arm, randomized exploratory Phase 2 study was designed to compare the combination of ficlatuzumab and gefitinib versus gefitinib monotherapy, in clinically selected Asian subjects with previously untreated advanced NSCLC who have a high likelihood of harboring activating EGFR mutations. Ninety-four (94) patients were randomized to gefitinib and ficlatuzumab/gefitinib arms, respectively; 144 tumor tissue samples were available for biomarker analysis. Subjects who demonstrated disease control (complete response, partial response, or stable disease for 12 weeks or longer) in the gefitinib alone arm were eligible to cross-over upon progression to a combination of gefitinib and ficlatuzumab to assess whether acquired resistance to gefitinib can be overcome with the addition of ficlatuzumab. About Ficlatuzumab and the HGF/c-MET Pathway HGF is a ligand that binds to and activates a receptor called c-Met. Activation of the HGF/c-Met pathway is believed to be important in normal processes in embryonic development and wound healing, but is also believed to trigger many activities involved in cancer development and metastasis. HGF/c-Met has been shown to be one of the most potent drivers of tumor growth in AVEO’s Human Response Platform. HGF/c-Met over-expression is observed in many solid tumors including breast, colorectal, gastric, head and neck, lung and prostate, as well as hematologic malignancies 1. Additionally, c-Met and EGFR are frequently co-amplified and co-expressed in a variety of tumor types; HGF/c-Met pathway upregulation can render EGFR-targeted therapy resistance, and vice-versa 2-4. Ficlatuzumab is a humanized IgG1 antibody that binds to the HGF ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway.
About AVEOAVEO Pharmaceuticals (NASDAQ: AVEO) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients’ lives. AVEO’s proprietary Human Response Platform™ provides the company unique insights into cancer biology and is being leveraged in the discovery and clinical development of its cancer therapeutics. For more information, please visit the company’s website at www.aveopharma.com. Cautionary Note Regarding Forward-Looking Statements Any statements in this press release about AVEO’s future expectations, plans and prospects, including statements about: the potential efficacy and safety of ficlatuzumab; advancement of the ficlatuzumab clinical development plans in lung cancer and head and neck cancer; ficlatuzumab’s therapeutic potential in combination with EGFR targeted therapies; the potential of AVEO’s cancer biology platform and biomarker capabilities to offer a unique advantage in oncology drug development; and other statements containing the words "believes," "anticipates," "plans," "expects," "potential," "will" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: AVEO’s ability to successfully research, develop and obtain and maintain regulatory approvals for ficlatuzumab and its other product candidates, including risks relating to its ability to successfully advance clinical development of ficlatuzumab for the treatment of lung cancer; the possibility that favorable historical preclinical and clinical trial results may not be predictive of the results in future preclinical and clinical trials; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; unplanned operating expenses; AVEO’s ability to raise substantial additional funds to achieve its goals, including with respect to the further development of ficlatuzumab; competition; general economic and industry conditions; and other factors discussed in the "Risk Factors" section of AVEO’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, and in other filings that AVEO periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, AVEO specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing AVEO’s views as of any date subsequent to the date of this press release. 1. Christensen JG, et al. Cancer Letters: 225:1-26.2. Engelman JA, et al. Science. 316:1039-43.3. Turke AB, et al. Cancer Cell. 17:77-88.4. Yano S, et al. Cancer Res. 68:9479-87.