Good News for Amgen's Oncolytic virus - maybe big-pharma will look closer at Oncy
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumor tissue and to initiate a systemic anti-tumor immune response.
Of the 295 patients treated with talimogene laherparepvec, almost 4,000 tumor lesions were tracked for this analysis. Half of these lesions were injected with talimogene laherparepvec at least once, while the rest were not injected, including visceral tumor lesions (tumors involving solid organs such as the lungs and liver). The results showed a 50 percent or greater reduction in tumor size in 64 percent of injected tumors. In addition, one-third of uninjected non-visceral tumors, and 15 percent of visceral tumors were also reduced by at least 50 percent. There were 35 melanoma-related surgeries performed during this trial of which 30 percent successfully removed all residual disease.
The most frequently observed adverse events in the Phase 3 study were fatigue, chills and pyrexia. The most common serious adverse events include disease progression in both groups, and cellulitis and pyrexia in the talimogene laherparepvec group. Serious adverse events occurred in 26 percent of talimogene laherparepvec patients and 13 percent of GM-CSF patients. Immune-mediated events were reported infrequently.
"These data add to the body of evidence supporting talimogene laherparepvec's local and distant effect, and its potential ability to stimulate a systemic anti-tumor immune response," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Melanoma remains a devastating and difficult-to-treat disease, and talimogene laherparepvec continues to demonstrate encouraging results in this setting."
nome observed that the Amgen Tvec trial would not produce approvable results because it tested against sagramostim and not the SOC. That made sense. But these reported results - 50% or greater reduction in 64% of injected tumors, 33% of non-injected non-visceral tumors and 15% of visceral tumors - are impressive when compared to historical SOC. Good enough IMO to get an FDA OK. And I agree that should certainly have a positive effect on reo's potential & shareprice.
I began to think the GM-CSF doublet was a nonevent when Jennerex sold out for next to nothing. I wonder how they feel after seeing these results.
The last link to reality on this board just broke. FDA approval for tumor shrinkage? I thought you were smarter than that. BTW Amgen bought Biovex not Jennerex. A minor difference. REO is not tvec. Coffe is not water- pork is not beef- etc How is the trial going??? Longer is better!!!!!! Wonder what happened to poor l'il REO 015 whose OS data you were promised years ago?