Biotech Values

[genisi]

Stage IV melanoma patients have very few options and awful 5-year survival rates. Pazdur is quite right calling DTIC (and I'd add Temodar) "toxic placebo". IL-2 has better effect on the disease but AEs are too severe for most patients to tolerate. Ipilimumab's MoA is not as smart as Provange, it isn't specific, rather it is generally upregulating the immune response therefore causing many AEs. However, like you said the bar in melanoma isn't all that high and ipi's risk/benefit profile makes me believe it will be approved. Question is will the FDA want to see the ipi+DTIC in 1st line data also or will the ipi+MDX-1379 in 2nd line data will be enough.