NEW YORK, BOSTON & DARMSTADT, Germany—A three-way agreement was announced today between Merck KGaA, Pfizer and Verastem for the evaluation of avelumab in combination with VS-6063 in patients with advanced ovarian cancer. No financial details were disclosed.
Ovarian cancer is the seventh most common cancer in women, with approximately 239,000 cases diagnosed annually worldwide. Given that symptoms can sometimes appear only in later disease stages, leading to later diagnosis, outcomes for women with ovarian cancer are generally poor. Currently, treatment options for epithelial ovarian cancer consist of surgery, radiotherapy, chemotherapy and targeted therapy, but women who can't undergo treatment with platinum-based chemotherapy due to resistance or refractory disease have very limited options.
“Combination strategies in immuno-oncology offer significant promise for patients in need. Through our collaboration with Verastem, we hope to accelerate our understanding of avelumab and its potential as a combination therapy with FAK inhibition for patients fighting ovarian cancer,” said Dr. Alise Reicin, head of Global Clinical Development at Merck’s biopharma business, which in the United States and Canada operates as EMD Serono.
Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody currently being investigated in a broad range of tumor types, with a Phase 1/1b clinical trial slated to begin in the second half of this year. The compound inhibits PD-L1 interactions, thereby enabling activation of T cells and the immune system. Merck and Pfizer began a strategic alliance in November 2014 for the co-development and co-commercialization of avelumab.
VS-6063 is Verastem's investigational focal adhesion kinase (FAK) inhibitor. The compound is orally available and functions via a multifaceted approach, reducing cancer stem cells, enhancing anti-tumor immunity and modulating the local tumor microenvironment. Clinical trials are currently underway to assess VS-6063's ability to improve patient survival.
The protein FAK is often overproduced in tumors, which in turn enables cancer cells to avoid attacks by the immune system. Preclinical research into the protein, published in Cell Sept. 24, 2015, shows that FAK inhibition can modulate the balance of immune cells in the tumor, increasing the presence of cytotoxic T cells in the tumor and decreasing the presence of immunosuppressive T regulatory cells. This research appeared in the article “FAK Controls Chemokine Transcription, Tregs and Evasion of Anti-tumor Immunity.”
“Through this collaboration, we hope to advance our understanding of how FAK inhibition may complement our development program for avelumab, with the ultimate goal of potentially achieving better outcomes for women with ovarian cancer,” Chris Boshoff, vice president and head of Early Development, Translational and Immuno-Oncology at Pfizer Oncology, remarked in a press release.
Robert Forrester, president and CEO of Verastem, added, “Recent research shows that FAK inhibitors could be beneficial in combination with immuno-oncology agents. We are excited to be working with Merck KGaA, Darmstadt, Germany, and Pfizer to build upon the early clinical signals observed in patients with ovarian cancer receiving combination therapy with VS-6063.”
SOURCE: Merck KGaA press release