Pipeline updates are highly awaited events in the pharmaceutical/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Earlier this week, AVEO Pharmaceuticals, Inc. (AVEO) and partner Biodesix, Inc. announced data from a retrospective exploratory analysis of treatment-naive Asian patients suffering from non small cell lung cancer (NSCLC) in a randomized phase II study on ficlatuzumab and AstraZeneca’s (AZN) Iressa (gefitinib). The phase II study evaluated the ficlatuzumab/Iressa combination in comparison with Iressa alone.
The exploratory analysis was made using Biodesix’ VeriStrat (a serum protein test) to identify patients who are most likely to benefit from the addition of ficlatuzumab to Iressa (an epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) therapy).
Data from the analysis showed that the addition of the ficlatuzumab to an EGFR TKI therapy resulted in significant clinical benefit to the patient subgroup which was labeled as “poor” under VeriStrat classification. However, ficlatuzumab failed to show any improvement in OS or PFS over Iressa alone in the intent-to-treat patient population. Additionally, no benefit in OS or PFS was observed in the patient subgroup labeled “good”.
We remind investors that AVEO and Biodesix has a worldwide agreement to develop and commercialize ficlatuzumab with a Biodesix companion diagnostic test for the treatment of NSCLC.
Under this agreement, AVEO and Biodesix intend to conduct a confirmatory phase II study using VeriStrat “poor” classification as a selective biomarker for the combination of ficlatuzumab and an EGFR-TKI compared to EGFR TKI alone for treating treatment-naive EGFR mutation-positive patients suffering from advanced NSCLC. The study is expected to commence by Dec 31, 2014.
Additionally, AVEO announced positive results from two phase II studies on tivozanib for metastatic colorectal cancer and renal cell carcinoma, respectively.
Notably, AVEO has terminated its lease agreement related to its headquarters located in Cambridge, MA, as part of its cost cutting measure. This has reduced AVEO’s lease obligations by $110 million. The company has also amended its debt financing facility with Hercules Technology Growth Capital. AVEO stated that these transactions will not affect its financial guidance (provided with its second-quarter results).
Investors interested in the health care sector may consider Gilead Sciences Inc. (GILD) and Medivation, Inc. (MDVN).
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