Evofosfamide fails in two late-stage cancer trials

Merck KGaA has announced that it is not planning to file for approval of evofosfamide in advanced soft tissue sarcoma and advanced pancreatic adenocarcinoma in light of results from two Phase III studies of evofosfamide in combination with chemotherapy in these cancers.

The Phase 3 studies are being conducted under Threshold’s collaboration with Merck KGaA.

In the Phase 3 MAESTRO study, patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma treated with evofosfamide in combination with gemcitabine did not demonstrate a statistically significant improvement in overall survival (OS) compared with gemcitabine plus placebo.

In the Phase 3 TH-CR-406/SARC021, patients with locally advanced unresectable or metastatic soft tissue sarcoma treated with evofosfamide in combination with doxorubicin did not demonstrate a statistically significant improvement in OS compared with doxorubicin alone.

Commenting on the outcome of the trials, Barry Selkick, Ph.D., Chiefe Executive Officer at Threshold, said,  “We are surprised and disappointed that these studies did not show that evofosfamide could extend the lives of patients with these two difficult-to-treat diseases.”

Merck KGaA has said it will now be redeploying its resources into high-profile future products, such as avelumab.

Merck KGaA to make a ‘quick decision’ on the future evofosfamide clinical programme

“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 programme.”

Merck KGaA has said it will share further details of the two Phase III studies with the scientific community once the data have been further analysed.

“Today’s results are disappointing for patients. Yet we are confident in our pipeline and will reallocate evofosfamide resources to accelerate other key programmes in oncology and immuno-oncology,” said Rossetti.