On September 25, 2015 Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC) (NASDAQ:ONCY) reported that Dr. D.W. Sborov and colleagues made a poster presentation at the 15th International Myeloma Workshop (IMW) (Press release, Oncolytics Biotech, SEP 25, 2015, View Source [SID:1234507549]). The poster presentation, entitled "Combination Carfilzomib and the Viral Oncolytic Agent REOLYSIN in Patients with Relapsed Multiple Myeloma: A Pilot Study Investigating Viral Proliferation," discloses initial findings from a pilot study (NCI-9603) in patients with relapsed or refractory multiple myeloma treated using the combination of carfilzomib and REOLYSIN. The IMW runs from September 23rd to 26th in Rome, Italy.
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Highlights of the data presented include:
100% of patients (8 of 8) experienced an objective response as measured by changes in blood monoclonal protein. Of these, 2 patients had a very good partial response (VGPR), 3 patients had a partial response (PR) and 3 patients had a minor response (MR);
Only one patient has progressed to date and five of eight remain on study;
The combination of carfilzomib and REOLYSIN produced a significant (p=0.005) increase in caspase-3, a marker associated with apoptotic (programmed) cell death; and
The treatment combination was associated with an increased infiltration of CD8+ T-cells and the significant (p=0.005) upregulation of PD-L1, suggesting that the addition of a PD-1 or PD-L1 inhibitor may further optimize the treatment regimen.
"These findings demonstrate that the combination of carfilzomib and REOLYSIN shows promise in hematological malignancies like multiple myeloma and provide compelling evidence that such drug combinations promote viral replication and cancer cell death," said Dr. Matt Coffey, Chief Operating Officer of Oncolytics. "Based on these results, we intend to move into randomized studies in this indication."
The investigators noted that this is the first time a REOLYSIN-based combination has been tested in relapsed multiple myeloma patients. A previous single-agent study conducted by the collaborators in this patient population showed that REOLYSIN was well tolerated. The collaborators and others were noted to have conducted preclinical investigations that demonstrated that the combination of REOLYSIN and carfilzomib synergistically increased the killing of multiple myeloma cells. This provided the clinical rationale for this study. In this study, the combination of carfilzomib and REOLYSIN produced a significant (p=0.005) increase in caspase-3, a marker associated with apoptotic cell death. The researchers also determined that the combination of REOLYSIN and carfilzomib increases infiltration of CD8+ T-cells and significantly (p=0.005) upregulates PD-L1. The investigators concluded that these findings necessitate continued investigation, and suggest that the addition of a PD-1 or PD-L1 inhibitor may further optimize the REOLYSIN and carfilzomib regimen.
"To this point, multiple myeloma has not responded to checkpoint inhibitor therapy," said Dr. Brad Thompson, President and CEO of Oncolytics. "The combination of REOLYSIN and carfilzomib upregulates PD-L1 and increases infiltration of CD8+ T-cells, which may make the tumor sensitive to anti-PD-L1 therapy. The follow-on randomized study we are currently planning is expected to have a patient group treated with the combination of REOLYSIN, a standard of care chemotherapy, and a checkpoint inhibitor, as well as a patient group receiving REOLYSIN and a standard of care chemotherapy."
NCI-9603 is a U.S. National Cancer Institute sponsored single-arm, open-label study of intravenously administered REOLYSIN with dexamethasone and carfilzomib to patients with relapsed or refractory multiple myeloma. Patients receive treatment on days 1, 2, 8, 9, 15 and 16 of a 28-day cycle, to be repeated in the absence of disease progression or unacceptable toxicity. Approximately 12 patients will be enrolled in the study. The primary outcomes include measuring reovirus replication, safety, and tolerability. Secondary outcomes include examining objective response, duration of response, clinical benefit, progression-free survival, and time to progression. Other outcomes will include the measurement of immunologic correlative markers.
A copy of the poster will be available on the Oncolytics website at: View Source
About Multiple Myeloma
Multiple Myeloma is a cancer of the plasma cells and the second most common hematological malignancy. The American Cancer Society estimates there will be 26,850 new cases diagnosed in the United States and 11,240 deaths from the disease in 2015.