Phase 3 Trial to Evaluate Avelumab as First-Line Ovarian Cancer Therapy

Avelumab is an experimental, full human anti-PD-L1 Ig G1 monoclonal antibody.

Merck recently announced plans for a phase 3 trial will evaluate avelumab as a first-line ovarian cancer treatment.

The trial will evaluate the safety and efficacy of avelumab in combination with platinum-based therapy and as a maintenance treatment in patients with locally advanced (stage 3) or metastatic (stage 4) previously untreated epithelial ovarian cancer.

JAVELIN Ovarian 100 is an open-label, international, multi-center, randomized (1:1:1) phase 3 study designed to evaluate the potential superiority of 2 first-line therapies with avelumab and platinum-based chemotherapy versus platinum-based chemotherapy alone. This will be assessed by progression-free survival.

Avelumab, also referred to as MSB0010718C, is an investigational, full human anti-PD-L1 Ig G1 monoclonal antibody.

“In an early ongoing study, avelumab showed encouraging tumor response rates in patients with recurrent of refractory ovarian cancer. Historically, ovarian cancer presents as an advanced disease with poor survival rates,” said Alise Reicin, MD, head of Global Clinical Development at Merck KGaA. “The hope is that avelumab can change the natural history of the disease and potentially take the survival rate beyond the current 5-year estimate.”

The study will enroll approximately 950 treatment naïve patients with locally advanced or metastatic ovarian cancer who will receive either concurrent avelumab and chemotherapy, avelumab following chemotherapy, or chemotherapy alone.

“Patients with ovarian cancer need additional treatment options,” said Chris Boshoff, MD, PhD, head of early development, Translational and Immune-Oncology, Oncology in Pfizer Global Product Development. “We believe there could be synergistic activity in the combination of avelumab and established treatments such as platinum-based chemotherapy. With 2 studies now underway of avelumab in ovarian cancer, we look forward to receiving the results from these trials and continuing to break ground in this hard-to-treat cancer.”