Evive Successfully Concludes China Phase III Clinical Trial of F-627 for Chemotherapy-induced Neutropenia

F-627 demonstrates positive results by meeting its primary endpoint Jan 06, 2020, Shanghai, China — Evive Biotech, an innovative biotech company developing novel biological therapeutics, today announced that its pivotal Phase III study in China for F-627 (efbemalenograstim alpha) to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients met its primary endpoint. F-627 is a dimeric recombinant human granulocyte colony-stimulating factor (rhG-CSF) IgG-Fc fusion protein that comprises a new class of long-acting G-CSF to manage CIN in cancer patients. F-627 met its non-inferiority primary clinical endpoint versus Recombinant Human Granulocyte Colony Stimulating Factor (GRAN® / NEUPOGEN®) in the first cycle of prophylactic treatment of CIN in subjects with breast cancer receiving chemotherapy. The duration of neutropenia in cycle one in patients treated with F-627 was not statistically different from patients treated with GRAN® (filgrastim). “Meeting this trial’s non-inferiority and safety endpoints demonstrates that F-627 has the same efficacy and safety as NEUPOGEN® (GRAN®) but with the convenience of NEULASTA®” said Dr. William Daley, Evive’s Chief Medical Officer. He added, “This reinforces F-627’s ability to be a strong first line application as well as a viable alternative for patients contraindicated or refractory to current treatment options.” Successful completion of this trial is a key milestone towards submitting F-627’s BLA application to the CDE. “Observing a trend in study-drug-related treatment emergent adverse events in favor of F-627 in this trial shows promise for this trend to continue in the upcoming readout from F-627’s global pivotal Phase III trial against NEULASTA®” said Dr. Juhong Liu, Evive’s Chief Scientific Officer. The China pivotal Phase III trial was a multi-center, randomized, open-label, active-controlled study comparing the efficacy and safety of Evive’s dimeric recombinant human granulocyte colony stimulating factor-fc fusion protein (F-627) and recombinant human granulocyte colony stimulating factor (GRAN® / NEUPOGEN®) in the prophylactic treatment of chemotherapy-induced neutropenia in women with breast cancer receiving myelotoxic EC chemotherapy treatment (epirubicin + cyclophosphamide). This trial was conducted specifically for regulatory submission to the Center for Drug Evaluation (CDE) at China’s National Medical Products Administration (NMPA). Separately, F-627’s global development program includes a Phase III placebo-controlled study completed in 2018 and a Phase III NEULASTA® controlled trial expected to read out in 2020 for submissions in the US and Europe. Chemotherapy-induced Neutropenia (CIN) CIN occurs commonly during current cancer treatments involving cytotoxic chemotherapy. Market research indicates that CIN affects more than 8 million people every year with over 2.5 million people affected in China alone. The global CIN market is estimated to be at $6.0 billion with about >85% of patients still on first-generation of rhG-CSFs, and less than 15% of patients using second-generation rhG-CSFs, the pegylated rhG-CSF.

The release as fetched from its publisher. evivebiotech.com ↗