Merck, Pfizer Start Phase III Trial for Ovarian Cancer Drug

Jul 06, 2016

Merck, Darmstadt, Germany, and Pfizer announced the initiation of a Phase III study, JAVELIN Ovarian 100, to evaluate the efficacy and safety of avelumab in combination with, and/or as follow-on (maintenance) treatment to, platinum-based chemotherapy in patients with locally advanced or metastatic disease (Stage III/IV) with previously untreated epithelial ovarian cancer.

JAVELIN Ovarian 100 is the first Phase III study evaluating the addition of an immune checkpoint inhibitor to standard-of-care in first-line treatment for this aggressive disease.

“In an early ongoing study, avelumab showed encouraging tumor response rates in patients with recurrent or refractory ovarian cancer,” said Alise Reicin, M.D., Head of Global Clinical Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which in the U.S. and Canada operates as EMD Serono. “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.”

JAVELIN Ovarian 100 is an open-label, international, multi-center, randomized (1:1:1) Phase III trial in treatment naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). This study is designed to evaluate 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 study will enroll approximately 950 patients, who will receive concurrent avelumab and chemotherapy, avelumab following chemotherapy, or chemotherapy alone.

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