Amgen has just released impressive results for their Oncolytic virus - This may be the trigger for a VLA deal. All studies to date have shown VLA to have better results.
First Randomized Study to Evaluate the Combination of IMLYGIC, an Oncolytic Viral Therapy, With a Checkpoint Inhibitor
Data Demonstrate IMLYGIC in Combination With YERVOY® (Ipilimumab) Doubled Objective Response Rate in Unresectable Advanced Melanoma
Responses Not Limited to Injected Lesions; 50 Percent or Higher Reduction in Visceral Lesion Size Occurred More Frequently in Patients in the Combination Arm
THOUSAND OAKS, Calif., June 3, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from the Phase 2 '264 study that demonstrated IMLYGIC® (talimogene laherparepvec) in combination with the immune checkpoint inhibitor YERVOY® (ipilimumab)* more than doubled objective response rate (ORR), defined as the proportion of patients with tumor size reduction, compared to YERVOY alone in patients with unresectable stage IIIB-IV melanoma, meeting the primary endpoint of the study. The analysis showed that 38.8 percent of patients treated with IMLYGIC plus YERVOY achieved an objective response versus 18 percent of patients treated with YERVOY alone (odds ratio=2.9, 95 percent CI: 1.5, 5.5; p=0.002). Patients in the combination arm also experienced nearly double the complete response rate compared to YERVOY alone (13.3 percent versus 7 percent). The results were presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO).
"Metastatic melanoma continues to be one of the most difficult-to-treat and aggressive cancers," said Jason Chesney, M.D., '264 study investigator and acting director of the James Graham Brown Cancer Center, University of Louisville, Louisville, Ky. "The results from this study demonstrate the potential of combining the complementary mechanisms of action of an oncolytic viral immunotherapy and a checkpoint inhibitor to enhance anti-tumor effect in patients with advanced melanoma."
Responses were not limited to injected lesions. Among patients with visceral disease treated with IMLYGIC plus YERVOY, 35 percent had a reduction in size of visceral lesions by at least 50 percent. The rate was 14 percent in patients in the YERVOY arm. Patients in the IMLYGIC plus YERVOY arm experienced a median progression-free survival (PFS) of 8.2 months (median follow up 68 weeks) versus 6.4 months in the YERVOY arm. The effect was not statistically significant (HR=0.83, 95 percent CI; p=0.35); however, the PFS analysis was not event-driven and is still ongoing, with only approximately 50 percent of PFS events reported at this time.
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