TVEC achieved all of it's primary endpoints with p values that were all in the 0.0001 range. The relative risk for progression was 0.13. The time to treatment failure was similarly spectacular. The data for overall survival endpoint has not come close to maturing as a large percentage of the treated group are still alive but censored (as dead) for this second analysis. A quick look at the survival KM shows a very large cohort of survivors in the middle of the treated survival curve. It won't take very much time for these survivors to influence the HR and the p values as the trial matures. The slopes of the curves differ by more than 20% but the censoring of the survivors really influences the data in the middle of the curve.
Doesn't really matter. Amgen tested TVEC against subcutaneous GMCSF, not against any of the current active agents. The comparator isn't valid to any evaluation for approval. Despite Amgen touting the data as evidence of Oncolytic Immunotherapy, there are no immunological data at all. The response data are a bit difficult to decipher as the company looked at a variable number of lesions to determine progression and injected a variable number of lesions, cutaneous and deep. Lots of other quibbling with the data.
Regardless, this provides an example of a successful Ph III trial of an oncolytic virus in a very difficult indication where early responses translate into an overall survival benefit. Amgen will now have to figure out what to do with this "proof of principle" Ph III study. They will either need to pair TVEC with new agents in melanoma and complete another Ph III or move into another indication.....or drop TVEC. Time will tell.
cheers, Geneman
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