A Phase 1b trial testing a combination of Reolysin (pelareorep), Velcade (bortezomib) and dexamethasone in multiple myeloma patients who failed to respond to previous therapy is opening a new treatment group — one that will add Keytruda (pembrolizumab) to this mix.
This extension of the ongoing REO 019 study (NCT02514382) is the result of a collaboration between Oncolytics Biotech – Reolysin’s developer — and the Keck School of Medicine at the University of Southern California (USC), where the main study is also taking place.
Reolysin, an investigative therapy, is a naturally occurring virus that does not cause disease, engineered to replicate only in cancer cells. When the virus replicates, cancer cells die, releasing additional virus particles that infect nearby cancer cells and can also recruit immune cells into the tumor site.
Reolysin is intended to turn “cold” tumors, those that are devoid of immune cells, into “hot” tumors.
REO 019 is currently evaluating Reolysin in combination with the proteasome inhibitor Velcade and dexamethasone, a corticosteroid, for the treatment of multiple myeloma patients who failed to respond or progressed after at least one prior treatment regimen.
Preliminary trial results, reported in 2016, show that this triple combination was well-tolerated and induced an immune system response in some of these heavily pre-treated patients.
However, the combination of proteasome inhibitors and Reolysin has also seen to increase PD-L1 expression in multiple myeloma cells, which helps the cancer escape immune surveillance.
Adding a PD-1 inhibitor like Keytruda, developed by Merck, to the existing combination may improve patient responses to the combination. According to a press release, final details on this extension will be announced once a first patient is enrolled, likely later this year.
Another Phase 1 study (NCT02101944) involving adults with advanced myeloma is also recruiting participants in at sites in Ohio and Utah. The safety, tolerability and efficacy of Reolysin in combination with Kyprolis (carfilzomib), also a proteasome inhibitor, and dexamethasone will be evaluated in about 28 patients.
Reolysin was granted fast track designation by the U.S. Food and Drug Administration (FDA) as a potential treatment of metastatic breast cancer. It has also been designated an orphan drug for its potential to treat glioblastoma, ovarian cancer and pancreatic cancer.