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Pfizer And Merck Germany Initiate Phase III Study To Assess Avelumab As First-line Treatment For Ovarian Cancer


Pfizer Inc. (NYSE: PFE) and Merck KGaA, Darmstadt, Germany, disclosed the commencement of a final stage trial of JAVELIN Ovarian 100 to assess the efficacy, as well as, safety of avelumab in combination with, and/or as follow-on treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease with previously untreated epithelial ovarian cancer.

According to Pfizer and Merck Germany, JAVELIN Ovarian 100 was the first final stage trial evaluating the addition of an immune checkpoint inhibitor to standard-of-care in first-line treatment for this aggressive disease.

Merck German's Head of Global Clinical Development, Alise Reicin, commented, "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."

The company indicated JAVELIN Ovarian 100 was an open-label, international, multi-center, randomized (1:1:1) final stage trial in treatment naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). The company also stated that this trial was meant to assess the potential superiority of two first-line therapies with avelumab and platinum-based chemotherapy versus platinum-based chemotherapy alone, as assessed by progression-free survival.

The companies indicated the trial would enroll about 950 patients, who will get concurrent avelumab and chemotherapy, avelumab following chemotherapy, or chemotherapy alone.

Pfizer's Head of Early Development, Translational and Immuno-Oncology, Chris Boshoff, said, "Patients with ovarian cancer need additional treatment options. We believe there could be synergistic activity in the combination of avelumab and established treatments such as platinum-based chemotherapy. With two 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."

Posted-In: Biotech News FDA General


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