Merck, Pfizer start phase III trial to assess avelumab as first-line treatment for ovarian cancer

The companies will use avelumab, a PD-L1 checkpoint inhibitor, together with a platinum-based chemotherapy for women with locally advanced or metastatic disease with earlier untreated epithelial ovarian cancer.

About 950 patients will be enrolled in the JAVELIN Ovarian 100 phase III trial, which will assess the potential superiority of two first-line therapies with avelumab and platinum-based chemotherapy versus platinum-based chemotherapy alone, as evaluated by progression-free survival.

Patients will receive concurrent avelumab and chemotherapy, avelumab following chemotherapy, or chemotherapy alone.

The new investigational regimen will assess avelumab in extending progression-free survival in treatment-naïve women.

Merck head of global clinical development in the biopharma business Alise Reicin said: "In an early ongoing study, avelumab showed encouraging tumor response rates in patients with recurrent or refractory ovarian cancer.

"Historically, ovarian cancer presents 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."

Last December, Merck and Pfizer started an international phase III study of avelumab as a treatment for platinum-resistant/refractory ovarian cancer.

The entire complete JAVELIN clinical development program for avelumab includes about 2,200 patients enrolled, being treated across more than 15 tumor types.

Avelumab is believed to have a dual mechanism of action which may allow the immune system to identify and attack cancer cells.

Image: Preclinic research at Merck Serono in Vevey, Switzerland. Photo: courtesy of Merck Group/Merck KGaA, Darmstadt, Germany.