Disappointing Phase III evofosfamide data
Evofosfamide has not met the primary endpoint of improving overall survival in two Phase III trials in soft tissue sarcoma (STS) and pancreatic cancer. Although some benefit was seen in pancreatic cancer, partner Merck (N:MRK) KGaA will not file either indication with regulators and Threshold Pharmaceuticals Inc (O:THLD) expects Merck to terminate the agreement. If this occurs, Threshold will consider all options for future evofosfamide development, which could include in combination with checkpoint inhibitors. We have placed our valuation and forecasts under review pending further updates. Threshold is now trading broadly in line with expected YE15 cash of $40-45m. THLD estimates that this should be sufficient to fund operations to end 2016, beyond initial tarloxotinib Phase II data availability, which is expected around mid-2016e.
In the Phase III pancreatic cancer trial evofosfamide combined with gemcitabine did improve overall survival (OS) versus gemcitabine alone, with a death hazard ratio (HR) of 0.84 (HR
Despite some activity in pancreatic cancer, partner Merck has decided not to pursue regulatory filing in either indication. Threshold also expects Merck to terminate the evofosfamide agreement. Evofosfamide is currently in a Phase II/III trial in lung cancer, in addition to development in other solid tumours and blood cancers, including glioblastoma and multiple myeloma. If Merck terminates, Threshold will consider the options for future evofosfamide development, which could include in combination with checkpoint inhibitors following preclinical data.
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