Merck KGaA and Pfizer have commenced the JAVELIN Ovarian 100 Phase III trial of avelumab combined with platinum-based chemotherapy to treat locally advanced or metastatic disease (Stage III or Stage IV) with an untreated epithelial ovarian cancer.
Avelumab is an investigational, fully human antibody, which targets a specific protein occurring on tumour cells called PD-L1, or programmed death ligand-1.
The open-label, international, multi-centre, randomised JAVELIN Ovarian 100 trial is designed to determine the superiority of two first-line therapies with avelumab and platinum-based chemotherapy versus platinum-based chemotherapy alone.
The result will be assessed on the basis of progression-free survival.
Around 950 patients afflicted with locally advanced or metastatic disease (Stage III or Stage IV) with previously untreated epithelial ovarian cancer will be involved in the trial.
The patients will be administered with concurrent avelumab and chemotherapy, avelumab following chemotherapy, or chemotherapy alone.
Merck KGaA global clinical development in the biopharma business head Alise Reicin said: "In an early ongoing study, avelumab showed encouraging tumour response rates in patients with recurrent or refractory ovarian cancer.
"Historically, ovarian cancer is presented as an advanced disease with poor survival rates.
"The hope is that avelumab can change the natural history of the disease and potentially take the survival rate beyond the current five year estimate."
Avelumab is believed to operate on a dual mechanism of action, which is expected to allows the immune system to detect and attack cancer cells.
It binds with PD-L1, which is thought to inhibit tumour cells from using PD-L1 to shield it against white blood cells such as T-cells, exposing them to anti-tumour responses.
Additionally, Avelumab is also believed to help white blood cells such as natural killer (NK) cells to terminate tumours in a process known as antibody-dependent, cell-mediated cytotoxicity (ADCC).