On December 8, 2015 Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC) (OTCQX:ONCYF) (FRA:ONY) reported that Dr. D.W. Sborov and colleagues made a poster presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Oncolytics Biotech, DEC 8, 2015, View Source [SID:1234508492]). The poster presentation, titled "REOLYSIN Combined with Carfilzomib for Treatment of Relapsed Multiple Myeloma Patients," discloses updated findings from a pilot study (NCI-9603) in patients with relapsed or refractory multiple myeloma treated using the combination of carfilzomib and REOLYSIN. The ASH (Free ASH Whitepaper) Annual Meeting runs from December 5th to 8th in Orlando, FL.

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Highlights of the data presented include:

All seven patients treated at the full clinical dose had a clinical response. Patients treated at the full clinical dose (dose level 1) had a deeper and more prolonged response than those treated at dose level minus 1. Of the 12 total patients treated, 11 had a decrease in dominant monoclonal protein during treatment (used to measure clinical response), including all seven patients treated at the full clinical dose;

The combination of carfilzomib and REOLYSIN produced a significant (p=0.005) increase in caspase-3, a marker associated with apoptotic (programmed) cell death, but to a higher degree in those patients treated at dose level 1; 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 are compelling as we continue to see a strong clinical benefit rate in this difficult to treat cancer, and clear evidence of a dose response, with patients at the higher dosing level seeing improved outcomes. We plan on testing higher dosage levels to determine the extent of this improvement," said Dr. Matt Coffey, Chief Operating Officer of Oncolytics. "We recently announced a second study in multiple myeloma examining REOLYSIN together with bortezomib, with the goal of identifying the best standard of care combination to advance into later stage clinical testing."

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.

"Based on these evolving data and input received from key opinion leaders, we believe multiple myeloma to be a compelling registration target," said Dr. Brad Thompson, President and CEO of Oncolytics. "We intend to discuss the design of a potential registration study with regulatory agencies."

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 outcome measures include reovirus replication, safety, and tolerability. Secondary outcome measures include examining objective response, duration of response, clinical benefit, progression-free survival, and time to progression. Other outcome measures will include 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.