The combination therapy of the Merck KGaA/Pfizer-partnered avelumab (MSB0010718C) and Verastem's VS-6063 will be assessed for advanced ovarian cancer, the companies said today, through a collaboration whose value was not disclosed.
The companies said they expected to launch a Phase I/Ib study evaluating escalating doses of the combination during the second half of this year.
“Through this collaboration, we hope to advance our understanding of how FAK [focal adhesion kinase] inhibition may complement our development program for avelumab, with the ultimate goal of potentially achieving better outcomes for women with ovarian cancer,” Chris Boshoff, vp and head of early development, translational and immuno-oncology at Pfizer Oncology, said in a statement.
Avelumab, which is Merck’s lead immuno-oncology compound, is a fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought potentially to enable the activation of T cells and the adaptive immune system.
Merck and Pfizer are co-commercializing avelumab for a range of cancers under an up-to-$2.85 billion strategic alliance launched in November 2014 that raised their presence in cancer immunotherapies. The companies are expected to launch up to 20 “high priority” immuno-oncology clinical development programs involving the compound, including up to six Phase II or Phase III trials.
As of February 2, according to Pfizer’s website, avelumab is under Phase III study as a monotherapy in platinum-resistant/refractory ovarian cancer as well as in first- and second-line non-small cell lung cancers, first- and third-line gastric cancers, and first-line urothelial cancer. Avelumab is also in Phase II study for metastatic Merkel cell carcinoma, for which the compound has won FDA’s breakthrough, Fast Track, and Orphan drug designations.
Last year, Pfizer and Merck began an avelumab-related companion diagnostics collaboration with Dako, an Agilent Technologies company
VS-6063, Verastem’s lead product candidate, is an inhibitor of FAK, a protein often overproduced in tumors, enabling cancer cells to evade attack by the immune system. Verastem has previously reported initial signs of clinical activity in patients with ovarian cancer when VS-6063 is used in combination with paclitaxel.
Verastem’s collaboration with Merck KGaA and Pfizer is the second clinical study announced this year in which VS-6063 is being assessed as part of a combination therapy. In January, Washington University in St. Louis initiated a Phase I dose-escalation study designed to evaluate Verastem’s compound with Merck & Co.’s anti-PD-1 immunotherapy pembrolizumab and gemcitabine in patients with pancreatic cancer.