Threshold Pharmaceuticals: Effective In Japan?
Edison | Apr 28, 2016 08:18AM ET
Following analysis of the Phase III data of evofosfamide (TH-302) in unresectable or metastatic pancreatic cancer patients, which failed on an intent-to-treat basis (p=0.0588), Threshold Pharmaceuticals (NASDAQ:THLD) has announced that the drug seemed to demonstrate impressive efficacy among the patients in Japan. Overall survival in the Japanese subset was 13.6 months vs 9.1 months in the control arm (p=0.0106). The company is currently seeking a partner in Japan and reaching out to the Pharmaceutical and Medical Device Agency (PMDA) to understand the potential path forward.
Filing possible on existing data
While any retrospective subset analysis should be viewed with caution, the fact that it is based on 116 patients and that Abraxane was able to garner Japanese approval for unresectable pancreatic cancer based upon data in a 34-patient, single-arm open-label study with similar median overall survival (13.6 months for evofosfamide and 13.5 months for Abraxane) provides some comfort.
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