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Endocyte Announces Results of Supplemental Analyses of PRECEDENT Trial

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Endocyte, Inc, a biopharmaceutical company developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy, has announced the results of supplemental analyses of its Phase 2b PRECEDENT trial.

PRECEDENT was a randomized trial of EC145 in combination with pegylated liposomal doxorubicin (PLD) in women with platinum-resistant ovarian cancer. Results confirmed the reliability of its companion imaging diagnostic EC20 to select targeted patients. In addition, the blinded independent review committee (IRC) and numerous sensitivity analyses confirmed the robustness of the progression-free survival (PFS) results, particularly in the FR(++) patient population, patients whose tumors are all positive for the targeted folate receptor. The overall survival results were inconclusive as the trial was not sufficiently powered to show an overall survival advantage and there was no trend toward benefit in either arm.

“We believe these findings continue to support the robustness of the PRECEDENT trial results, particularly in the group of FR(++) patients. It was important that EC20 validated for the selection of FR(++) patients so we may use it to specifically select this group of patients for clinical trials,” said Ron Ellis, Endocyte’s president and chief executive officer. “These women, who account for approximately 40 percent of the platinum resistant ovarian cancer patient population, have a particularly poor prognosis with existing therapies, both because of their resistance to platinum therapy and also because of the abundance of folate receptors in their disease, which encourage cancer cell growth. However, these patients are also observed to have the greatest benefit from EC145, due to its ability to target this important receptor.”