Cancer Research UK announced the launch of a first clinical trial under the Experimental Cancer Medicine Centre (ECMC) Combinations Alliance, a collaborative effort involving the group, and, for this study, the companies MSD and Verastem.
The three will conduct a Phase 1b/2a trial of a new combination of immunotherapy drugs in mesothelioma, non-small cell lung cancer (NSCLC), and pancreatic cancer. Specifically, they will investigate whether a Verastem-owned FAK inhibitor, called VS-6063 (defactinib), can improve the effectiveness of Keytruda (pembrolizumab), an MSD-owned PD-1 immunotherapy.
Mesothelioma, NSCLC, and pancreatic cancer have poor survival rates. “Immunotherapy is a very exciting area of cancer research and we’ve seen remarkable benefits from pembrolizumab for some patients with hard-to-treat cancers, like melanoma and lung cancer,” Dr. Stefan Symeonides, a trial co-leader with the University of Edinburgh, said in a press release. “We’re hoping that the addition of defactinib will extend those benefits to more patients. This work could one day give a new treatment option that saves lives for this group of patients who have few options.”
FAK is a non-receptor tyrosine kinase encoded by the PTK-2 gene that is involved in cellular adhesion and, in cancer, greater metastatic capability. The study’s aim is two-fold: testing whether defactinib can remove a barrier of immune cells tricked into protecting cancer cells, while pembrolizumab activates cancer-killing immune cells to attack the newly exposed cancer cells.
It draws on recent discoveries by scientists at the Edinburgh Cancer Research UK Centre (University of Edinburgh), showing that inhibiting focal adhesion kinase (FAK) could release an immune response to cancer.
Planned to begin enrolling patients at centers in the U.K. later this year or early in 2017, the trial is expected to treat between 50 and 60 people with the combination, starting with a small dose and building up, to determine its safety profile. The research team will also assess how well the treatment targets the cancers, and its effects on tumors.
“It’s vital that we find new treatments for these three cancers which take tens of thousands of lives each year in the UK and we’re delighted to be working with MSD and Verastem on this,” said Dr. Ian Walker, director of clinical research at Cancer Research UK. “Our Combinations Alliance was set up to help develop partnerships between drug development companies and researchers to try new combinations of drugs in the hope of improving treatments and saving more lives from cancer. This is our first success in bringing together two organizations and we hope that this combination of immunotherapy drugs will benefit patients.”
The Phase 1b/2a clinical trial (NCT02758587),which will be co-sponsored by the University of Glasgow and NHS Greater Glasgow and Clyde, will be conducted by the ECMC network centers in Edinburgh-Dundee, Southampton, Glasgow, Leicester, and Belfast. Cancer Research UK’s clinical trial unit in Glasgow will manage the trial.
More information is available on the study’s clinical trials.gov webpage, or by clicking on its identification number, above.