Late-stage failure for Merck and Threshold cancer drug
pharmafile | December 7, 2015 | News story | Research and Development, Sales and Marketing | Merck, Pancreatic cancer, Threshold Pharmaceuticals, evofosfamide, late-stage failure, phase III, sarcoma
Merck and its development partner Threshold Pharmaceuticals say they will not pursue regulatory approval for evofosfamide in advanced soft tissue sarcoma and advanced pancreatic adenocarcinoma, after two late-stage trial failures.
The decision was made in light of results from two Phase III studies of evofosfamide in combination with chemotherapy in these two types of cancer. Merck says it would refocus its resources into other products and programmes, including avelumab – its investigational anti-PD-L1 antibody – in combination with Pfizer.
“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,” says Luciano Rossetti, head of global research and development at the biopharma business of Merck KGaA
“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.”
In the Phase III MAESTRO study, patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma treated with evofosfamide and gemcitabine did not demonstrate a statistically significant improvement in overall survival (OS) compared with Eli Lilly’s Gemzar (gemcitabine) plus placebo.
Evofosfamide in combination with doxorubicin also failed to show OS benefit over doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue in another trial.
Merck has worked on evofosfamide with Threshold since the two companies signed a global license and co-development agreement in 2012. The chief executive of the San Francisco-based biotech, Barry Selick, said the company was ‘surprised and disappointed’ by the trial results.
“Threshold has been pursuing evofosfamide for over ten years in collaboration with world-class scientists and investigators throughout the world. While we believe there remains substantial data to support the role of hypoxia in cancer treatment resistance, we are deeply frustrated with our inability in these trials to impact that in a meaningful way. I would like to thank all of the patients and their families, and the physicians, nurses, and support staff who participated in these studies,” he comments.
Detailed results from both studies will be submitted for presentation at upcoming international scientific meetings and for publication in peer-reviewed journals.
Joel Levy
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