Darmstadt, Germany, December 7, 2015 – Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that it is not planning to file for approval of evofosfamide in advanced soft tissue sarcoma and advanced pancreatic adenocarcinoma. The decision was made in light of the results from two Phase III studies of evofosfamide in combination with chemotherapy in these two types of cancer, as reported by Threshold Pharmaceuticals Inc. today. Merck KGaA, Darmstadt, Germany, will now be redeploying its resources into high-profile future products, such as avelumab* and all other priority programs in oncology, immuno-oncology and immunology.
“Despite seeing signs of activity in pancreatic cancer, pre-specified primary endpoints were not met in both studies and therefore the data do not support filing in these indications,” said Luciano Rossetti, Head of Global Research and Development at the biopharma business of Merck KGaA, Darmstadt, Germany. “We decided today not to pursue investigation of evofosfamide in soft tissue sarcoma and pancreatic cancer, and we will be making a quick decision on the future of the ongoing evofosfamide clinical program.”
Details of the two Phase III studies will be shared with the scientific community once the data have been further analyzed.
“Today’s results are disappointing for patients. Yet we are confident in our pipeline and will reallocate evofosfamide resources to accelerate other key programs in oncology and immuno-oncology,” said Rossetti.
The pharmaceutical pipeline of Merck KGaA, Darmstadt, Germany, is focusing on oncology, immuno-oncology and immunology. In immuno-oncology, the company, together with Pfizer, is researching avelumab, an investigational anti-PD-L1 antibody, in more than 15 tumor types.
*Avelumab is the proposed International Nonproprietary Name for the anti-PD-L1 monoclonal antibody (MSB0010718C). Avelumab is under clinical investigation and has not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a bis-alkylating agent that is preferentially activated under severe tumor hypoxic conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.
Merck KGaA, Darmstadt, Germany, signed a global license and co-development agreement for evofosfamide with Threshold Pharmaceuticals, Inc. in February 2012, with an option for Threshold to co-commercialize in the U.S.